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Clinical Futility of TAK 500 met. No further development with this compound
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This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors.
The aims of the study are:
Participants may receive TAK-500 for up to 1 year. Participants may continue with their treatment if they have continuing benefit and if this is approved by their study doctor. Participants who are receiving TAK-500 either alone or with pembrolizumab will continue with their treatment until their disease progresses or until they or their study doctor decide they should stop this treatment.
The drug being tested in this study is called TAK-500. The study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of TAK-500 when used as a single agent (SA) and in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors.
The study will be conducted in 2 phases: Dose Escalation and Dose Expansion Phase. The study will enroll approximately 313 participants (approximately 82 in the Dose Escalation Phase and approximately 231 in Dose Expansion Phase). The dose escalation phase will determine the recommended dose of TAK-500 along with the combination agents for the dose expansion phase. All the participants will be assigned to one of the 9 arms:
This multi-center trial will be conducted globally. Participants with demonstrated clinical benefit may continue treatment beyond 1 year if approved by the sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Agent Dose Escalation: TAK-500 8 µg/kg | Experimental | Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year. |
|
| Single Agent Dose Escalation: TAK-500 8 µg/kg + 1 TOCI | Experimental | Participants received premedication with 8 mg/kg tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
|
| Single Agent Dose Escalation: TAK-500 16 µg/kg | Experimental | Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
|
| Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 DEX | Experimental | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
|
| Single Agent Dose Escalation: TAK-500 16 µg/kg + 2 DEX | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAK-500 | Drug | TAK-500 IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). | Up to approximately 32.8 months |
| Dose Escalation: Number of Participants With Grade 3 or Higher TEAEs | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. | Up to approximately 32.8 months |
| Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0. | Up to Cycle 1 (1 cycle = 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Cmax: Maximum Serum Concentration for TAK-500 | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) | |
| Dose Escalation: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500 |
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Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
Individuals with the following pathologically confirmed (cytological diagnosis is adequate) select locally advanced or metastatic solid tumors, whose disease has progressed on or are intolerant to standard therapy:
Gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma (HCC), nonsquamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), mesothelioma, triple-negative breast cancer (TNBC), renal clear cell carcinoma (RCC) and nasopharyngeal carcinoma (NPC). Participants who are intolerant to all standard therapies are those who have developed clinical or laboratory abnormalities that prevent continued drug administration as evaluated by the principal investigator at the time of screening.
For dose expansion in 2L nonsquamous NSCLC (TAK-500 plus pembrolizumab):
Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic nonsquamous NSCLC.
Participants may not have a known targetable driver mutation, rearrangement or amplification (eg, EGFR, ALK, MET, ROS1, BRAF, KRASG12C, etc.).
Must have had disease progression while on or following 1 prior line of therapy:
- Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting. OR Disease progression/recurrence within 6 months of the completion of anti-PD-(L)1 therapy if administered in the adjuvant/neoadjuvant setting. Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA4 antibody and/or chemotherapy (eg, carboplatin and pemetrexed).
Participants are eligible regardless of PD-L1 status.
For dose expansion in 3L nonsquamous NSCLC (TAK-500 SA):
Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic nonsquamous NSCLC.
Participants may not have a known targetable driver mutation, rearrangement or amplification (eg, EGFR, ALK, MET, ROS1, BRAF, KRASG12C, etc.).
Must have had disease progression while on or following 2 prior lines of therapy:
Participants are eligible regardless of PD-L1 status.
For dose expansion in 2L pancreatic adenocarcinoma (TAK-500 SA and TAK-500 plus pembrolizumab):
Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic pancreatic adenocarcinoma.
Must have had disease progression while on or following 1 prior line of therapy:
- One prior line of fluorouracil- or gemcitabine-based chemotherapy (eg, FOLFIRINOX, FOLFOX, FOLFIRI, gemcitabine/nab-paclitaxel) in the metastatic/recurrent locally advanced setting. Prior chemotherapy in the neoadjuvant/adjuvant setting does not qualify unless the participant had progression of disease within 6 months of completion of neoadjuvant/adjuvant chemotherapy.
Must not have had prior exposure to anti-PD-(L)1 therapy.
Participants with MSI-H/dMMR disease are not eligible.
Participants are eligible regardless of PD-L1 status.
For dose expansion in 3L RCC (TAK-500 plus pembrolizumab):
Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic RCC.
Must have had disease progression while on or following 2 prior lines of therapy:
Participants are eligible regardless of PD-L1 status.
Must have at least 1 RECIST version 1.1 measurable lesion. Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions unless there has been demonstrated radiographic progression in that lesion. RECIST v1.1 target lesions must include at least 1 lesion that was not previously irradiated.
Adequate bone marrow, renal, and hepatic functions, as determined by the following laboratory parameters:
Left ventricular ejection fraction (LVEF) >50%, as measured by echocardiogram or multiple gated acquisition scan (MUGA) within 4 weeks before receiving the first dose of study drug.
For participants with HCC only: Child-Pugh score less than or equal to 7 (Child-Pugh A or B7).
Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version 5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy.
Participants previously treated with fully human/humanized antineoplastic monoclonal antibodies must not have received treatment with such antibodies for at least 4 weeks or the time period equal to the dosing interval, whichever is shorter. No washout period is required for prior treatment with pembrolizumab or other anti-programmed cell death protein 1 (PD-1) antibodies, although the first study dose of these drugs must not occur at an interval less than standard of care (that is, 3 weeks for 200 mg of IV pembrolizumab).
Exclusion Criteria:
History of any of the following <=6 months before first dose of study drug(s): congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, persistent hypertension >=160/100 millimeters of mercury (mmHg) despite optimal medical therapy, ongoing cardiac arrhythmias of Grade >2 (including atrial flutter/ fibrillation or intermittent ventricular tachycardia), other ongoing serious cardiac conditions (example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy), or symptomatic cerebrovascular events. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.
QT interval with Fridericia correction method >450 milliseconds (men) or >475 milliseconds (women) on a 12- lead ECG during the screening period.
Grade >=2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 predose assessment.
Oxygen saturation <92% on room air at screening or during C1D1 predose assessment.
Treatment with other STING agonists/antagonists, Toll-like receptor agonists or CCR2 agonist/antagonist within the past 6 months.
Active diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade >=2 pleural effusion not controlled by tap or requiring indwelling catheters.
Grade >=2 fever of malignant origin.
Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV] RNA).
History of hepatic encephalopathy.
Prior or current clinically significant ascites, as measured by physical examination, that requires active paracentesis for control.
Treatment with any investigational products or other anticancer therapy (including chemotherapy, targeted agents, and immunotherapy), within 14 days or 5 half-lives, whichever is shorter, before C1D1 of study drug(s).
Radiation therapy within 14 days (42 days for radiation to the lungs) and/ or systemic treatment with radionuclides within 42 days before C1D1 of study drug(s). Participants with clinically relevant ongoing pulmonary complications from prior radiation therapy are not eligible.
Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 14 days of C1D1 of study drug(s), with the following exceptions:
Recipients of allogeneic or autologous stem cell transplantation or organ transplantation.
Additional criteria specific for participants in TAK-500 and pembrolizumab combination arm only:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| City of Hope Comprehensive Cancer Center |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link | View source |
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Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Participants with the specified pathologically confirmed locally advanced or metastatic solid tumors, whose disease had progressed on or is intolerant to all standard therapy were enrolled in the study. The study was terminated before initiation of Dose Expansion Phase.
Participants took part in the study at sites in the United States from 14 April 2022 to 06 January 2025.
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Agent Dose Escalation: TAK-500 8 µg/kg | Participants received TAK-500, 8 micrograms per kilogram (µg/kg), intravenous (IV) infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year. |
| FG001 | Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 13, 2023 | Dec 11, 2025 |
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Participants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year.
|
| Single Agent Dose Escalation: TAK-500 16 µg/kg + 1 TOCI | Experimental | Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year. |
|
| Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX | Experimental | Participants received premedication with dexamethasone 10 mg tablets orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
|
| Single Agent Dose Escalation: TAK-500 24 µg/kg + 1 TOCI | Experimental | Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year. |
|
| Single Agent Dose Escalation: TAK-500 40 µg/kg + 2 DEX | Experimental | Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
|
| Single Agent Dose Escalation: TAK-500 60 µg/kg + 2 DEX | Experimental | Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W for up to 1 year. |
|
| Combination Dose Escalation: TAK-500 8 µg/kg + 1 TOCI + Pembrolizumab | Experimental | Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year. |
|
| Combination Dose Escalation: TAK-500 16 µg/kg + Pembrolizumab + 1 TOCI | Experimental | Participants received premedication with 8 mg/kg tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year, along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year. |
|
| Combination Dose Escalation: TAK 500 24 µg/kg + Pembrolizumab + 2 DEX | Experimental | Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year. |
|
| Combination Dose Escalation: TAK-500 40 µg/kg + Pembrolizumab + 2 DEX | Experimental | Participants received premedication with dexamethasone 10 mg tablet orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W , for up to 1 year along with pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle Q3W for up to 1 year. |
|
| Dose Expansion: TAK-500 | Experimental | Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase. |
|
| Pembrolizumab | Drug | Pembrolizumab IV infusion. |
|
| Tocilizumab | Drug | Tocilizumab IV infusion. |
|
| Dexamethasone | Drug | Dexamethasone IV infusion. |
|
| Dexamethasone | Drug | Dexamethasone tablet. |
|
| Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Serious Adverse Events (SAEs) |
A TEAE is an AE for which the date of onset was on or after the first dose of any study drug and on or before 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). Treatment-emergent SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. |
| Up to approximately 32.8 months |
| Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). | Up to approximately 32.8 months |
| Dose Expansion: Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve confirmed partial response (cPR) or confirmed complete response (cCR) (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete response (CR): defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. Partial response (PR): defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response. | Up to approximately 32.8 months |
| Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
| Dose Escalation: AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500 | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
| Dose Escalation: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500 | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
| Dose Escalation: t1/2: Terminal Disposition Phase Half-life for TAK-500 | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
| Dose Escalation: CL: Total Clearance After Intravenous Administration for TAK-500 | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
| Dose Escalation: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-500 | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
| Dose Escalation: Changes in Intratumoral Tumor Cell Infiltration | Measurement of changes in tumor immune cell infiltration were measured by immunohistochemistry on fresh tumor biopsies taken pre and post treatment (up to 23 days after first administration of TAK-500) for each participant. | Up to 23 days after first administration of TAK-500 |
| Dose Escalation: Number of Participants With Positive Anti-drug Antibody (ADA) (Acquired Immunogenicity) | Number of participants with positive ADA at any scheduled post-baseline visit are reported. | Up to approximately 32.8 months |
| Dose Escalation: Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve cPR or cCR (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per RECIST Version 1.1. CR: defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response. | Up to approximately 32.8 months |
| Dose Escalation: Disease Control Rate (DCR) | DCR is defined as the percentage of participants who achieve cCR + cPR + stable disease (SD) or better (determined by the investigator) greater than (>) 6 weeks during the study in the response-evaluable population. DCR will be assessed as per RECIST Version 1.1. CR: disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions. | Up to approximately 32.8 months |
| Dose Escalation: Duration of Response (DOR) | DOR is defined as the time from the date of first documentation of a cPR or better to the date of first documentation of PD for responders (cPR or better). Responders without documentation of PD will be censored at the date of last response assessment that is SD or better. DOR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions. | Up to approximately 32.8 months |
| Dose Escalation: Time to Response (TTR) | TTR is defined as the time from the date of first dose administration to the date of first documented cPR or better (determined by the investigator) in the safety population. TTR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. | Up to approximately 32.8 months |
| Dose Expansion: Progression Free Survival (PFS) | PFS is defined as the time from date of study treatment to the first documented PD based on RECIST v.1.1, or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions. | Up to approximately 32.8 months |
| Dose Expansion: Overall Survival (OS) | OS is defined as the time from the date of first dose administration to the date of death. | Up to approximately 32.8 months |
| Dose Expansion: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). | Up to approximately 32.8 months |
| Dose Expansion: Number of Participants With Grade 3 or Higher TEAEs | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. | Up to approximately 32.8 months |
| Dose Expansion: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT will be defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0. | Up to approximately 32.8 months |
| Dose Expansion: Number of Participants Reporting One or More Treatment-emergent SAEs | Up to approximately 32.8 months |
| Dose Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). | Up to approximately 32.8 months |
| Duarte |
| California |
| 91010 |
| United States |
| University of California San Diego | La Jolla | California | 92093 | United States |
| University of Colorado - Anschutz Medical Campus - PPDS | Aurora | Colorado | 80045 | United States |
| Sarah Cannon Research Institute | Denver | Colorado | 80218 | United States |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | United States |
| Northwestern | Chicago | Illinois | 60611 | United States |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| New York University | New York | New York | 10016-4744 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| Sarah Cannon Cancer Institute | Nashville | Tennessee | 37203 | United States |
| START South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |
Participants received premedication with 8 milligrams per kilogram (mg/kg) (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| FG002 | Single Agent Dose Escalation: TAK-500 16 µg/kg | Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| FG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| FG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| FG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| FG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| FG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| FG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| FG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| FG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year. |
| FG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| FG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| FG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| FG014 | Dose Expansion: TAK-500 | Participants were planned to receive TAK-500 at recommended doses based on dose escalation cohorts. No participants were enrolled in the expansion phase due to early termination of the study before initiating this phase. |
| Response-evaluable Analysis Set | The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation. |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single Agent Dose Escalation: TAK-500 8 µg/kg | Participants received TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) for up to 1 year. |
| BG001 | Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab (TOCI) followed by TAK-500, 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| BG002 | Single Agent Dose Escalation: TAK-500 16 µg/kg | Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| BG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| BG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| BG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| BG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| BG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| BG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| BG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| BG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| BG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| BG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| BG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| BG014 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). | Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab). | Posted | Count of Participants | Participants | Up to approximately 32.8 months |
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| Primary | Dose Escalation: Number of Participants With Grade 3 or Higher TEAEs | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. | Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab). | Posted | Count of Participants | Participants | Up to approximately 32.8 months |
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| Primary | Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT was defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0. | The DLT-evaluable analysis set included participants who received all required doses of TAK-500 (with pembrolizumab if in a combination cohort) and remain on study for 21 days from first dosing of TAK-500 (through C1D21) without experiencing a DLT or who have a DLT during the first 21 days after study drug administration. | Posted | Count of Participants | Participants | Up to Cycle 1 (1 cycle = 21 days) |
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| Primary | Dose Escalation: Number of Participants Reporting One or More Treatment-emergent Serious Adverse Events (SAEs) | A TEAE is an AE for which the date of onset was on or after the first dose of any study drug and on or before 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). Treatment-emergent SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. | Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab). | Posted | Count of Participants | Participants | Up to approximately 32.8 months |
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| Primary | Dose Escalation: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). | Safety analysis set included participants who had received at least 1 dose, even if incomplete, of any study drug (i.e., TAK-500 or pembrolizumab). | Posted | Count of Participants | Participants | Up to approximately 32.8 months |
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| Primary | Dose Expansion: Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve confirmed partial response (cPR) or confirmed complete response (cCR) (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. Complete response (CR): defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. Partial response (PR): defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response. | Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure. | Posted | Up to approximately 32.8 months |
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| Secondary | Dose Escalation: Cmax: Maximum Serum Concentration for TAK-500 | Data at multiple pre-specified Pharmacokinetic (PK) timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported. | Posted | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
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| Secondary | Dose Escalation: Tmax: Time to Reach the Maximum Serum Concentration (Cmax) for TAK-500 | Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported. | Posted | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
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| Secondary | Dose Escalation: AUCt: Area Under the Serum Concentration-time Curve From Time 0 to Time t for TAK-500 | Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported. | Posted | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
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| Secondary | Dose Escalation: AUCinf: Area Under the Serum Concentration-time Curve From Time 0 to Infinity for TAK-500 | Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported. | Posted | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
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| Secondary | Dose Escalation: t1/2: Terminal Disposition Phase Half-life for TAK-500 | Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported. | Posted | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
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| Secondary | Dose Escalation: CL: Total Clearance After Intravenous Administration for TAK-500 | Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported. | Posted | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
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| Secondary | Dose Escalation: Vss: Volume of Distribution at Steady State After Intravenous Administration for TAK-500 | Data at multiple pre-specified PK timepoints (required for calculating the PK parameters) could not be obtained because of the scarce PK sampling and early study termination. Due to this insufficiency of the data, PK parameters could not be derived and thus not reported. | Posted | Pre-infusion and multiple timepoints post-infusion from Day 1 to Day 15 of Cycles 1, 2, 3, 4, 9, and 15 (Cycle length=21 days) |
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| Secondary | Dose Escalation: Changes in Intratumoral Tumor Cell Infiltration | Measurement of changes in tumor immune cell infiltration were measured by immunohistochemistry on fresh tumor biopsies taken pre and post treatment (up to 23 days after first administration of TAK-500) for each participant. | The tumor biopsy analysis set included participants from the safety population who had baseline and at least 1 postbaseline tumor biopsy sample assessments. | Posted | Mean | Standard Deviation | cells per square millimeter (cells/mm^2) | Up to 23 days after first administration of TAK-500 |
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| Secondary | Dose Escalation: Number of Participants With Positive Anti-drug Antibody (ADA) (Acquired Immunogenicity) | Number of participants with positive ADA at any scheduled post-baseline visit are reported. | The immunogenicity analysis set consisted of participants who received at least 1 dose of TAK-500 and had an ADA status assessment at baseline, and at least 1 postbaseline sample. Overall number analyzed is the number of participants with data available for analyses. | Posted | Count of Participants | Participants | Up to approximately 32.8 months |
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| Secondary | Dose Escalation: Overall Response Rate (ORR) | ORR is defined as the percentage of participants who achieve cPR or cCR (determined by the investigator) during the study in the response-evaluable population. ORR will be assessed as per RECIST Version 1.1. CR: defined as disappearance of all target and non- target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than <10 mm. PR: defined as at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. cPR or cCR is defined as a PR or CR that is confirmed with additional imaging 6 weeks after initial response. | The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation. | Posted | Number | percentage of participants | Up to approximately 32.8 months |
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| Secondary | Dose Escalation: Disease Control Rate (DCR) | DCR is defined as the percentage of participants who achieve cCR + cPR + stable disease (SD) or better (determined by the investigator) greater than (>) 6 weeks during the study in the response-evaluable population. DCR will be assessed as per RECIST Version 1.1. CR: disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions. | The response-evaluable analysis set, a subset of the safety analysis set, included participants with measurable disease at baseline and at least 1 posttreatment tumor evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to approximately 32.8 months |
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| Secondary | Dose Escalation: Duration of Response (DOR) | DOR is defined as the time from the date of first documentation of a cPR or better to the date of first documentation of PD for responders (cPR or better). Responders without documentation of PD will be censored at the date of last response assessment that is SD or better. DOR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD). PD: at least a 20% increase in the sum of diameters of target lesions. | As no participant had a response, there were no evaluable participants for the analyses of this outcome measure. | Posted | Up to approximately 32.8 months |
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| Secondary | Dose Escalation: Time to Response (TTR) | TTR is defined as the time from the date of first dose administration to the date of first documented cPR or better (determined by the investigator) in the safety population. TTR will be assessed as per RECIST Version 1.1. PR: at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. | As no participant had a response, there were no evaluable participants for the analyses of this outcome measure. | Posted | Up to approximately 32.8 months |
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| Secondary | Dose Expansion: Progression Free Survival (PFS) | PFS is defined as the time from date of study treatment to the first documented PD based on RECIST v.1.1, or death due to any cause, whichever occurs first. PD: at least a 20% increase in the sum of diameters of target lesions. | Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure. | Posted | Up to approximately 32.8 months |
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| Secondary | Dose Expansion: Overall Survival (OS) | OS is defined as the time from the date of first dose administration to the date of death. | Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure. | Posted | Up to approximately 32.8 months |
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| Secondary | Dose Expansion: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). | Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure. | Posted | Up to approximately 32.8 months |
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| Secondary | Dose Expansion: Number of Participants With Grade 3 or Higher TEAEs | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). TEAE Grades will be evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. | Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure. | Posted | Up to approximately 32.8 months |
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| Secondary | Dose Expansion: Number of Participants With Dose Limiting Toxicities (DLTs) | DLT will be defined as any of the TEAEs that occur during Cycle 1 and are considered by the investigator to be at least possibly related to TAK-500 as a SA or in combination with pembrolizumab. Toxicity will be evaluated according to NCI CTCAE version 5.0. | Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure. | Posted | Up to approximately 32.8 months |
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| Secondary | Dose Expansion: Number of Participants Reporting One or More Treatment-emergent SAEs | Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure. | Posted | Up to approximately 32.8 months |
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| Secondary | Dose Expansion: Number of Participants With One or More TEAEs Leading to Dose Modifications and Treatment Discontinuations | AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. A TEAE was reported as an AE for which the date of onset was on or after the first dose of any study drug and on or before the 30 days after the last dose of any study drug (or 90 days after the last dose of study drug for immune-mediated AEs). | Due to early study termination, Dose Expansion Phase was not initiated and hence, no data was collected for this outcome measure. | Posted | Up to approximately 32.8 months |
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|
Up to approximately 32.8 months
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Agent Dose Escalation: TAK-500 8 µg/kg | Participants received TAK-500 dose escalation dose starting at 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (once every 3 weeks, Q3W) or once on Day 1, 15 and 29 of each 42-day treatment cycle (once every 2 weeks, Q2W), for up to 1 year. | 1 | 3 | 3 | 3 | 3 | 3 |
| EG001 | Single Agent Dose Escalation: 1 TOCI + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) TOCI followed by TAK-500 8 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year. | 1 | 3 | 3 | 3 | 3 | 3 |
| EG002 | Single Agent Dose Escalation: TAK-500 16 µg/kg | Participants received 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year. | 1 | 5 | 4 | 5 | 5 | 5 |
| EG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year. | 1 | 3 | 2 | 3 | 3 | 3 |
| EG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 16 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 16 µg/kg IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year. | 2 | 7 | 5 | 7 | 7 | 7 |
| EG006 | Single Agent Dose Escalation: TAK-500 24 µg/kg + 2 DEX | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 24 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year. | 0 | 3 | 2 | 3 | 3 | 3 |
| EG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500 24 µg/kg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year. | 0 | 2 | 2 | 2 | 2 | 2 |
| EG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 40 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year. | 2 | 6 | 3 | 6 | 6 | 6 |
| EG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of 60 µg/kg TAK-500, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle, Q2W, for up to 1 year. | 1 | 4 | 4 | 4 | 4 | 4 |
| EG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year. | 2 | 5 | 3 | 5 | 5 | 5 |
| EG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W or once on Day 1, 15 and 29 of each 42-day treatment cycle Q2W, for up to 1 year. | 2 | 5 | 4 | 5 | 5 | 5 |
| EG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. | 2 | 7 | 6 | 7 | 7 | 7 |
| EG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. | 0 | 5 | 4 | 5 | 5 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cerebellar stroke | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Device malfunction | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Metastases to peritoneum | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Splenic embolism | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acidosis hyperchloraemic | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Allergic cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Appetite disorder | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bile duct stenosis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood fibrinogen increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chromaturia | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Cytokine release syndrome | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diabetic wound | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Early satiety | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Erosive oesophagitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Glycosuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hepatic encephalopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Herpes simplex reactivation | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypermagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Infusion site extravasation | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| International normalised ratio increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lumbar radiculopathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mesenteric vein embolism | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal candidiasis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumonitis aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Polyarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Superficial vein thrombosis | Vascular disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Troponin I increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 27.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | TrialDisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 20, 2024 | Dec 11, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D008113 | Liver Neoplasms |
| D008654 | Mesothelioma |
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D009303 | Nasopharyngeal Neoplasms |
| D007680 | Kidney Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D008107 | Liver Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018301 | Neoplasms, Mesothelial |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| C502936 | tocilizumab |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG002 | Single Agent Dose Escalation: TAK-500 16 µg/kg | Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
|
|
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
|
|
| OG002 | Single Agent Dose Escalation: TAK-500 16 µg/kg | Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
|
|
| OG002 | Single Agent Dose Escalation: TAK-500 16 µg/kg | Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
|
|
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg |
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
|
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg |
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
|
| OG003 |
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg |
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| OG003 |
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg |
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg |
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg |
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| OG003 |
| Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg |
Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W , for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| OG002 | Single Agent Dose Escalation: TAK-500 16 µg/kg | Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| OG002 | Single Agent Dose Escalation: TAK-500 16 µg/kg | Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| Single Agent Dose Escalation: TAK-500 16 µg/kg |
Participants received TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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| OG003 | Single Agent Dose Escalation: 1 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone (DEX) as a single 10 mg IV bolus 1 hour before the administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG004 | Single Agent Dose Escalation: 2 DEX + TAK-500 16 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle (Q3W) for up to 1 year. |
| OG005 | Single Agent Dose Escalation: 1 TOCI + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 16 µg/kg, IV infusion, intravenously, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG006 | Single Agent Dose Escalation: 2 DEX + TAK-500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG007 | Single Agent Dose Escalation: 1 TOCI + TAK-500 24 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG008 | Single Agent Dose Escalation: 2 DEX + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG009 | Single Agent Dose Escalation: 2 DEX + TAK-500 60 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of TAK-500, 60 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG010 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 8 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle or on Days 1 and 22 in a 42-day cycle (Q3W) for up to 1 year, along with TAK-500, 8 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG011 | Combination Dose Escalation: 1 TOCI + Pembrolizumab + TAK-500 16 µg/kg | Participants received premedication with 8 mg/kg (maximum of 800 mg in a single dose) tocilizumab followed by pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 16 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle Q3W, for up to 1 year. |
| OG012 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK 500 24 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 24 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
| OG013 | Combination Dose Escalation: 2 DEX + Pembrolizumab + TAK-500 40 µg/kg | Participants received premedication with dexamethasone 10 mg orally 12 hours prior and 10 mg IV bolus 1 hour before administration of pembrolizumab 200 mg IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year, along with TAK-500, 40 µg/kg, IV infusion, once on Day 1 of each 21-day treatment cycle, Q3W, for up to 1 year. |
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