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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1252-0338 | Registry Identifier | WHO |
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In this study, adults with non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) and squamous-cell carcinoma of the head and neck (SCCHN) will be treated with TAK-676 and pembrolizumab following radiotherapy. The main aims of this study are to check if people are improving after treatment with TAK-676, getting side effects from these combined treatments, and how much TAK-676 people with these cancers can receive without getting unacceptable side effects from it.
Participants will receive radiotherapy, then at least 40 hours later will receive pembrolizumab followed by TAK-676 slowly through a vein (infusion). Participants will receive an infusion of pembrolizumab at the same dose every 3 weeks. Different small groups of participants will receive lower to higher doses of TAK-676 on specific days of a 21-day cycle. This study will be happening at sites in North America.
The drug being tested in this study is called TAK-676. This study will evaluate the safety, tolerability and preliminary antitumor activity of TAK-676 with pembrolizumab following radiation therapy in the treatment of advanced NSCLC, TNBC or SCCHN that has progressed on checkpoint inhibitors (CPIs) and will estimate the maximum tolerated dose (MTD) and determine the recommended phase 2 dose (RP2D) of this combination.
The study will enroll approximately 65 participants. Participants will be assigned to dose escalating cohorts based on Bayesian Optimal Interval (BOIN) design. The starting dose of TAK-676 will be 0.2 mg and the subsequent dosing will be initiated based on the available safety and tolerability data from the previous cohort.
This multi-center trial will be conducted in the United States. There will be many clinic visits. The number of visits will depend on the number of cycles of treatment. Participants will attend an end of treatment (EOT) visit 30 days after receiving their last dose of study drug or before the start of subsequent systemic anticancer therapy, whichever occurs first. They might continue to have check-ups every 12 weeks if they left the study for a reason apart from their cancer getting worse.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Dose Escalation Phase: Radiation + Pembrolizumab + TAK-676 | Experimental | Participants will receive image-guided radiation therapy between Day -8 and Day -2. Participants will then receive pembrolizumab 200 milligram (mg), infusion, intravenously (IV), once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by TAK-676 infusion with escalating doses (0.2 mg and above), IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab | Drug | IV infusion. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity | AE: any untoward medical occurrence in participants administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. Severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1: Mild (asymptomatic/mild symptoms; clinical/diagnostic observations only; intervention not indicated); Grade 2: Moderate (minimal, local/noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3: Severe (severe/medically significant but not immediately life-threatening hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death related to AE. | From first dose of study drug administration up to 32 months |
| Number of Participants With Dose-limiting Toxicities (DLTs) | A DLT was defined as any TEAE that occurred during Cycle 1 and was considered by investigator to be at least possibly related to TAK-676 in combination with pembrolizumab. TEAEs meeting DLT definitions occurring in later cycles were considered in the determination of recommended phase 2 dose (RP2D) of TAK-676. DLTs were assessed based on NCI CTCAE version 5.0. | During Cycle 1 (cycle length= 21 days) |
| Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) | TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. An SAE is defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) may require intervention to prevent items 1 through 5 above. b) may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) Assessed by Investigator as Per RECIST v1.1 | ORR was defined as the percentage of participants who achieved confirmed complete response (cCR) or confirmed partial response (cPR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version1.1 (RECIST, V1.1). Complete Response (CR) for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 millimeter (mm) and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (<10 mm short axis). Partial Response (PR) was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to nearest single decimal place. |
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Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Participants must have at least 2 measurable lesions (i.e. ≥10 mm longest diameter for extranodal lesions, ≥15 mm short axis for lymph nodes), with at least one inside and at least one other outside of the radiation field. The tumor outside the radiation field must be accessible for biopsy, and the participant must consent to tumor biopsy at screening and during treatment.
Participants must have pathologically confirmed (cytological diagnosis is adequate) advanced or metastatic NSCLC, TNBC, or SCCHN who have:
Adequate bone marrow, renal and hepatic functions.
Left ventricular ejection fraction (LVEF) >50%, as measured by echocardiogram or multiple-gated acquisition (MUGA) scan within 4 weeks before receiving the first dose of study drug.
Clinically significant toxic effects of previous therapy have recovered to Grade 1 (per NCI CTCAE, V5.0) or baseline, except for alopecia, Grade 2 peripheral neuropathy, and/or autoimmune endocrinopathies with stable endocrine replacement therapy.
Exclusion Criteria:
History of any serious cardiac or cerebrovascular conditions in the last 6 months, including uncontrolled congestive heart disease, unstable angina, myocardial infarction, hypertension greater than or equal to (≥) 160/100 millimeter of mercury (mmHg) in spite of optimal therapy, cardiac arrhythmias, pericardial effusion, cardiomyopathy, or symptomatic stroke. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular weight heparin, will be allowed.
History of brain metastasis unless:
Known history of uncontrolled autoimmune disorders, human immunodeficiency virus (HIV) infection, or other relevant congenital or acquired immunodeficiencies.
Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV]-ribonucleic acid [RNA]).
Treatment with any investigational products and systemic anticancer drugs (including vascular endothelial growth factor (VEGF) inhibitors), within 14 days or 5 half-lives, whichever is shorter, before Cycle 1 Day 1 (C1D1) of study drugs.
Prior radiation to lesions chosen for biopsy or response assessment.
Prior radiation to lesions other than those chosen for radiation therapy or biopsy in the current protocol within 4 weeks of C1D1 of study drug(s).
Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 7 days of start of radiation therapy, with the following exceptions:
Receipt of live attenuated vaccine (example, tuberculosis Bacillus Calmette-guerin [BCG] vaccine, oral polio vaccine, measles, rotavirus, yellow fiver) within 28 days of C1D1 of study drug(s).
Recipients of allogeneic or autologous stem cell transplantation or organ transplantation.
Ongoing Grade ≥2 infection or participants with Grade ≥2 fever of malignant origin.
Fridericia's corrected QT interval (QTcF) >450 milliseconds (msec) (males) or >475 msec (females) on a 12-lead electrocardiogram (ECG) during the screening period.
Grade ≥2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 pre-dose assessment.
Oxygen saturation less than (<) 92% on room air at screening or during C1D1 predose assessment.
Use of medications that are known clinical organic anion transporting polypeptide 1B1 (OATP1B1) and/or OATP1B3 inhibitors, concurrently or within 14 days of C1D1 of study drugs.
Current smoker.
Vaping within 90 days of C1D1 of study drugs.
Current diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade ≥2 pleural effusion or ascites not controlled by tap or requiring indwelling catheters.
Treated with other stimulator of interferon genes (STING) agonists/antagonist and toll-like receptors agonists within the past 6 months.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Duarte | California | 91010-3012 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41888610 | Derived | Saravanakumar A, Deng R, Dong L, Haridas S, Xia CQ, Appleman VA, Abu-Yousif AO, Piatkov K, Wang H. Population-Based Modeling to Predict Human PK/PD of TAK-500, an Anti-CCR2 Antibody-Drug Conjugate for First-in-Human Study in Cancer Patients. Clin Transl Sci. 2026 Apr;19(4):e70522. doi: 10.1111/cts.70522. | |
| 41296842 | Derived |
| 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 a diagnosis of non-small-cell lung cancer (NSCLC), triple-negative breast cancer (TNBC) or squamous-cell carcinoma of the head and neck (SCCHN) were enrolled to receive radiotherapy, pembrolizumab 200 milligram (mg), intravenous (IV) infusion and TAK-676 IV infusion.
Participants took part in the study at 5 investigative sites in the United States from 09 September 2021 to 30 April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiation + Pembrolizumab +Dazostinag 0.2 Milligrams (mg) | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| 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 | Feb 18, 2022 | Apr 30, 2025 |
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| TAK-676 |
| Drug |
IV infusion. |
|
| Image-guided radiation therapy | Radiation | Radiation therapy. |
|
| From first dose of study drug administration up to 32 months |
| Number of Participants With One or More TEAEs Leading to Dose Modifications | TEAE: Any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. | From first dose of study drug administration up to 32 months |
| Number of Participants With One or More TEAEs Leading to Treatment Discontinuation | TEAE: Any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. | From first dose of study drug administration up to 32 months |
| Up to 32 months |
| Duration of Response (DOR) For All Tumor Lesions Assessed by Investigator as Per RECIST v1.1 | DOR:time from 1st documentation of cPR/better to 1st documentation of progressive disease(PD) for responders(cPR or better).PR:at least 30% decrease in sum of LD of target lesions,with reference of baseline sum LD.2nd assessment confirming PR must have taken place at least 4 weeks after response of interest.PD of Target Lesions:at least 20% increase in sum of LD of target lesions,with reference of smallest sum LD recorded since treatment started/appearance of 1/more new lesions.PD of Nontarget Lesions:unequivocal progression of existing non-target lesions.Responders without documentation of PD were censored at last response assessment that was stable disease(SD) or better.SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,with reference of smallest sum LD since treatment started.Evaluation was determined by investigator according to RECIST, V1.1.2nd assessment confirming CR/PR must have taken place at least 4 weeks after response of interest. | Up to 32 months |
| Time to Response (TTR) For All Tumor Lesions Assessed by Investigator as Per RECIST v1.1 | TTR was defined as the time from the date of first dose administration to the date of first documented cPR or better as determined by the investigator according to RECIST, V1.1. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | Up to 32 months |
| Overall Response Rate Assessed by Investigator as Per Modified Intratumoral Immunotherapy RECIST (Modified itRECIST) | ORR was defined as the percentage of participants who achieve cCR or cPR as determined by the investigator according to Modified itRECIST. CR for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (<10 mm short axis). PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to the nearest single decimal place. | Up to 32 months |
| Overall Response Rate For Tumors Within the Radiation Field (ORRirradiated) | ORRirradiated was defined as the percentage of participants who achieve cCRirradiated or cPRirradiated in the tumor lesions lying within the radiation field as determined by the investigator according to modified itRECIST. CR for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (<10 mm short axis). PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to the nearest single decimal place. | Up to 32 months |
| Overall Response Rate For Tumors Outside the Radiation Field (ORRnonirradiated) | ORRnonirradiated was defined as the percentage of participants who achieve cCRnonirradiated or cPRnonirradiated in the tumor lesions lying outside of the radiation field as determined by the investigator according to modified itRECIST. CR for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (<10 mm short axis). PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to the nearest single decimal place. | Up to 32 months |
| Duration of Response (DOR) For Tumors Within the Radiation Field (DORirradiated) | DORirradiated for tumor lesions lying within radiation field: as time from the date of first documentation of a cPRirradiated or better to the date of first documentation of irradiated PD in those lesions for irradiated responders (cPRirradiated or better). PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Irradiated responders without documentation of irradiated PD were censored at the date of last response assessment that is irradiated SD or better. PD of Target Lesions: at least a 20% increase in sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of 1 or more new lesions. PD of Nontarget Lesions: unequivocal progression of existing non-target lesions. Evaluation was determined by the investigator according to modified itRECIST. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | Up to 32 months |
| Duration of Response (DOR) For Tumors Outside the Radiation Field (DORnonirradiated) | DORnonirradiated for tumor lesions lying outside of the radiation field was defined as time from the date of first documentation of a cPRnonirradiated or better to the date of first documentation of nonirradiated PD in those lesions for nonirradiated responders (cPRnonirradiated or better). PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Nonirradiated responders without documentation of nonirradiated PD were censored at the date of last response assessment that is nonirradiated SD or better. Evaluation was determined by the investigator according to modified itRECIST. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | Up to 32 months |
| Time to Response (TTR) For Tumors Within the Radiation Field (TTRirradiated) | TTRirradiated in the tumor lesions lying within the radiation field was defined as the time from the date of first dose administration to the date of first documented cPRirradiated or better as determined by the investigator according to modified itRECIST. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | Up to 32 months |
| Time to Response (TTR) For Tumors Outside the Radiation Field (TTR Nonirradiated) | TTR nonirradiated in the tumor lesions lying outside of the radiation field was defined as the time from the date of first dose administration to the date of first documented cPRnonirradiated or better during the study in response-evaluable population as determined by the investigator according to modified itRECIST. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | Up to 32 months |
| Number of Participants With Increase in T-Cell Infiltration in Tumor Evaluated by Immunohistochemistry | The T-cell infiltration levels were calculated as a change from pre-treatment to post-treatment levels. Number of participants who expressed increase in T-cell infiltration levels between the pre-treatment and post-treatment tumor biopsies are reported. | Up to approximately 32 months |
| Chicago |
| Illinois |
| 60637-1443 |
| United States |
| Laura And Isaac Perlmutter Cancer Center | New York | New York | 10016-4744 | United States |
| Providence Portland Medical Center | Portland | Oregon | 97213-2933 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-0021 | United States |
| Cooper BT, Iams WT, Page DB, Yuan Y, Gerber NK, Luke JJ, Gibbs JP, Gregory RC, Wong KK, Deng J, Perera SA, Ding K, Roberts ER, Berger A, Christensen CL, Tong EX, Maldonado Lopez AE, Appleman VA, Leonard EJ, Parent A, Huang YC, Bay C, Li C, Lineberry N, Raizer J, Olson DJ, Chmura SJ. Phase 1b Study of Dazostinag plus Pembrolizumab after Hypofractionated Radiotherapy in Patients with Select Advanced Solid Tumors. Cancer Res Commun. 2025 Dec 1;5(12):2249-2263. doi: 10.1158/2767-9764.CRC-25-0566. |
| 36923556 | Derived | Carideo Cunniff E, Sato Y, Mai D, Appleman VA, Iwasaki S, Kolev V, Matsuda A, Shi J, Mochizuki M, Yoshikawa M, Huang J, Shen L, Haridas S, Shinde V, Gemski C, Roberts ER, Ghasemi O, Bazzazi H, Menon S, Traore T, Shi P, Thelen TD, Conlon J, Abu-Yousif AO, Arendt C, Shaw MH, Okaniwa M. TAK-676: A Novel Stimulator of Interferon Genes (STING) Agonist Promoting Durable IFN-dependent Antitumor Immunity in Preclinical Studies. Cancer Res Commun. 2022 Jun 23;2(6):489-502. doi: 10.1158/2767-9764.CRC-21-0161. eCollection 2022 Jun. |
| FG001 | Radiation + Pembrolizumab +Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| FG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| FG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| FG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| FG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| FG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| FG007 | Radiation Only | Participants received radiation therapy with daily image guidance using a fractionated dose of 8 gray (Gy) × 3. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set included participants who received at least 1 dose of radiation.
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiation + Pembrolizumab +Dazostinag 0.2 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| BG001 | Radiation + Pembrolizumab +Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| BG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| BG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| BG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| BG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| BG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| BG007 | Radiation Only | Participants received radiation therapy with daily image guidance using a fractionated dose of 8 gray (Gy) × 3. |
| BG008 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| 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 |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Based on TEAEs Severity | AE: any untoward medical occurrence in participants administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. Severity grade is defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0. Grade 1: Mild (asymptomatic/mild symptoms; clinical/diagnostic observations only; intervention not indicated); Grade 2: Moderate (minimal, local/noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3: Severe (severe/medically significant but not immediately life-threatening hospitalization/prolongation of hospitalization indicated; disabling; limiting self-care ADL); Grade 4: Life-threatening consequences, urgent intervention indicated; Grade 5: Death related to AE. | Safety Analysis Set included participants who received at least 1 dose of radiation. | Posted | Count of Participants | Participants | From first dose of study drug administration up to 32 months |
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| Primary | Number of Participants With Dose-limiting Toxicities (DLTs) | A DLT was defined as any TEAE that occurred during Cycle 1 and was considered by investigator to be at least possibly related to TAK-676 in combination with pembrolizumab. TEAEs meeting DLT definitions occurring in later cycles were considered in the determination of recommended phase 2 dose (RP2D) of TAK-676. DLTs were assessed based on NCI CTCAE version 5.0. | The DLT-evaluable Analysis Set included participants who received all Cycle 1 doses of dazostinag, pembrolizumab and 3 doses of radiation without experiencing a DLT by the end of Cycle 1 follow-up and participants who received 3 doses of radiation, pembrolizumab, and the required dazostinag doses up until a DLT during Cycle 1. | Posted | Count of Participants | Participants | During Cycle 1 (cycle length= 21 days) |
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| Primary | Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) | TEAE: any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. An SAE is defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) may require intervention to prevent items 1 through 5 above. b) may expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization | Safety Analysis Set included participants who received at least 1 dose of radiation. | Posted | Count of Participants | Participants | From first dose of study drug administration up to 32 months |
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| Primary | Number of Participants With One or More TEAEs Leading to Dose Modifications | TEAE: Any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. | Safety Analysis Set included participants who received at least 1 dose of radiation. | Posted | Count of Participants | Participants | From first dose of study drug administration up to 32 months |
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| Primary | Number of Participants With One or More TEAEs Leading to Treatment Discontinuation | TEAE: Any AE either reported for the first time or worsening of a pre-existing event after the first dose of study drug is considered treatment emergent. | Safety Analysis Set included participants who received at least 1 dose of radiation. | Posted | Count of Participants | Participants | From first dose of study drug administration up to 32 months |
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| Secondary | Overall Response Rate (ORR) Assessed by Investigator as Per RECIST v1.1 | ORR was defined as the percentage of participants who achieved confirmed complete response (cCR) or confirmed partial response (cPR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version1.1 (RECIST, V1.1). Complete Response (CR) for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 millimeter (mm) and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (<10 mm short axis). Partial Response (PR) was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to nearest single decimal place. | The response-evaluable analysis subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 32 months |
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| Secondary | Duration of Response (DOR) For All Tumor Lesions Assessed by Investigator as Per RECIST v1.1 | DOR:time from 1st documentation of cPR/better to 1st documentation of progressive disease(PD) for responders(cPR or better).PR:at least 30% decrease in sum of LD of target lesions,with reference of baseline sum LD.2nd assessment confirming PR must have taken place at least 4 weeks after response of interest.PD of Target Lesions:at least 20% increase in sum of LD of target lesions,with reference of smallest sum LD recorded since treatment started/appearance of 1/more new lesions.PD of Nontarget Lesions:unequivocal progression of existing non-target lesions.Responders without documentation of PD were censored at last response assessment that was stable disease(SD) or better.SD:neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,with reference of smallest sum LD since treatment started.Evaluation was determined by investigator according to RECIST, V1.1.2nd assessment confirming CR/PR must have taken place at least 4 weeks after response of interest. | The response-evaluable analysis subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Overall number of participants analyzed signifies participants who had cCR or cPR. Responders without documentation of PD were censored at the date of the last response assessment that was SD or better. | Posted | Median | 95% Confidence Interval | months | Up to 32 months |
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| Secondary | Time to Response (TTR) For All Tumor Lesions Assessed by Investigator as Per RECIST v1.1 | TTR was defined as the time from the date of first dose administration to the date of first documented cPR or better as determined by the investigator according to RECIST, V1.1. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | The Response-evaluable Analysis Subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Overall number of participants analyzed signifies participants who had cPR. | Posted | Median | 95% Confidence Interval | months | Up to 32 months |
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| Secondary | Overall Response Rate Assessed by Investigator as Per Modified Intratumoral Immunotherapy RECIST (Modified itRECIST) | ORR was defined as the percentage of participants who achieve cCR or cPR as determined by the investigator according to Modified itRECIST. CR for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (<10 mm short axis). PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to the nearest single decimal place. | The response-evaluable analysis subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 posttreatment evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 32 months |
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| Secondary | Overall Response Rate For Tumors Within the Radiation Field (ORRirradiated) | ORRirradiated was defined as the percentage of participants who achieve cCRirradiated or cPRirradiated in the tumor lesions lying within the radiation field as determined by the investigator according to modified itRECIST. CR for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (<10 mm short axis). PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to the nearest single decimal place. | The response-evaluable analysis subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 32 months |
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| Secondary | Overall Response Rate For Tumors Outside the Radiation Field (ORRnonirradiated) | ORRnonirradiated was defined as the percentage of participants who achieve cCRnonirradiated or cPRnonirradiated in the tumor lesions lying outside of the radiation field as determined by the investigator according to modified itRECIST. CR for Target Lesions was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to <10 mm and for Nontarget Lesions was defined as disappearance of all nontarget lesions and normalization of tumor marker level and all lymph nodes must be non-pathological in size (<10 mm short axis). PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. Percentages were rounded off to the nearest single decimal place. | The response-evaluable analysis subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 32 months |
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| Secondary | Duration of Response (DOR) For Tumors Within the Radiation Field (DORirradiated) | DORirradiated for tumor lesions lying within radiation field: as time from the date of first documentation of a cPRirradiated or better to the date of first documentation of irradiated PD in those lesions for irradiated responders (cPRirradiated or better). PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Irradiated responders without documentation of irradiated PD were censored at the date of last response assessment that is irradiated SD or better. PD of Target Lesions: at least a 20% increase in sum of the LD of target lesions, taking as reference the smallest sum LD recorded since treatment started or appearance of 1 or more new lesions. PD of Nontarget Lesions: unequivocal progression of existing non-target lesions. Evaluation was determined by the investigator according to modified itRECIST. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | The Response-evaluable Analysis Subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Overall number of participants analyzed signifies participants who had cCRirradiated or cPRirradiated. Responders without documentation of PD were censored at the date of the last response assessment that was SD or better. | Posted | Median | 95% Confidence Interval | months | Up to 32 months |
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| Secondary | Duration of Response (DOR) For Tumors Outside the Radiation Field (DORnonirradiated) | DORnonirradiated for tumor lesions lying outside of the radiation field was defined as time from the date of first documentation of a cPRnonirradiated or better to the date of first documentation of nonirradiated PD in those lesions for nonirradiated responders (cPRnonirradiated or better). PR was defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Nonirradiated responders without documentation of nonirradiated PD were censored at the date of last response assessment that is nonirradiated SD or better. Evaluation was determined by the investigator according to modified itRECIST. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | The Response-evaluable Analysis Subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Overall number of participants analyzed signifies participants who had cCRnonirradiated or cPRnonirradiated. Responders without documentation of PD were censored at the date of the last response assessment that was SD or better. | Posted | Median | 95% Confidence Interval | months | Up to 32 months |
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| Secondary | Time to Response (TTR) For Tumors Within the Radiation Field (TTRirradiated) | TTRirradiated in the tumor lesions lying within the radiation field was defined as the time from the date of first dose administration to the date of first documented cPRirradiated or better as determined by the investigator according to modified itRECIST. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | The response-evaluable analysis subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Overall number of participants analyzed signifies participants who had cPRirradiated. | Posted | Median | 95% Confidence Interval | months | Up to 32 months |
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| Secondary | Time to Response (TTR) For Tumors Outside the Radiation Field (TTR Nonirradiated) | TTR nonirradiated in the tumor lesions lying outside of the radiation field was defined as the time from the date of first dose administration to the date of first documented cPRnonirradiated or better during the study in response-evaluable population as determined by the investigator according to modified itRECIST. PR was defined as at least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. The second assessment confirming a CR or PR must have taken place at least 4 weeks after the response of interest. | The Response-evaluable Analysis Subset, a subset of the comprehensive response-evaluable analysis set, included participants with measurable disease at baseline and at least 1 post-treatment evaluation. Overall number of participants analyzed signifies participants who had cPRnonirradiated. | Posted | Median | 95% Confidence Interval | months | Up to 32 months |
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| Secondary | Number of Participants With Increase in T-Cell Infiltration in Tumor Evaluated by Immunohistochemistry | The T-cell infiltration levels were calculated as a change from pre-treatment to post-treatment levels. Number of participants who expressed increase in T-cell infiltration levels between the pre-treatment and post-treatment tumor biopsies are reported. | Overall number of participants analyzed are the participants who had paired samples (both pre-treatment and post-treatment biopsy sample) available for analysis, participants who did not have paired samples were not evaluable for this outcome measure. | Posted | Number | participants | Up to approximately 32 months |
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From first dose of study drug administration up to 32 months
Safety Analysis Set included participants who received at least 1 dose of radiation.
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 | Radiation + Pembrolizumab + Dazostinag 0.2 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.2 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG001 | Radiation + Pembrolizumab + Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first. | 0 | 2 | 1 | 2 | 2 | 2 |
| EG002 | Radiation + Pembrolizumab + Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first. | 1 | 4 | 3 | 4 | 4 | 4 |
| EG003 | Radiation + Pembrolizumab + Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG004 | Radiation + Pembrolizumab + Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first. | 1 | 7 | 3 | 7 | 7 | 7 |
| EG005 | Radiation + Pembrolizumab + Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first. | 2 | 6 | 0 | 6 | 5 | 6 |
| EG006 | Radiation + Pembrolizumab + Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or dazostinag or withdrawal of consent, whichever occurred first. | 1 | 6 | 3 | 6 | 6 | 6 |
| EG007 | Radiation Only | Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3. | 2 | 2 | 1 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Disease progression | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Abnormal loss of weight | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Amylase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Balance disorder | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| Blood creatinine increased | Investigations | MedDRA 27.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Chills | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Conjunctivitis viral | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Contrast media reaction | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Device malfunction | Product Issues | MedDRA 27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Facial paralysis | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
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| Hand fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypoparathyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lichenoid keratosis | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Lung abscess | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastases to spinal cord | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Metastatic neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Optic nerve disorder | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Radiation pneumonitis | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Radiation skin injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Toxic encephalopathy | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Tumour ulceration | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Vaginitis gardnerella | Infections and infestations | MedDRA 27.0 | Systematic Assessment | Number of participants at risk are female participants as this adverse event is specific to females. |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vestibular disorder | Ear and labyrinth disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | 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 | May 2, 2024 | Apr 30, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D064726 | Triple Negative Breast Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D006258 | Head and Neck Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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 |
|
| OG004 |
| Radiation + Pembrolizumab +Dazostinag 2.5 mg |
Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG007 | Radiation Only | Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3. |
| Number of Participants Reporting Any Grade 3 or Higher TEAEs |
|
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
|
|
| Radiation + Pembrolizumab +Dazostinag 0.4 mg |
Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG007 | Radiation Only | Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3. |
|
|
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG007 | Radiation Only | Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3. |
|
|
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG007 | Radiation Only | Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3. |
|
|
| OG001 | Radiation + Pembrolizumab +Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
|
|
| OG001 | Radiation + Pembrolizumab +Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
|
|
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
|
|
| OG001 | Radiation + Pembrolizumab +Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
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| OG001 | Radiation + Pembrolizumab +Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
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| OG001 | Radiation + Pembrolizumab +Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
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| OG001 | Radiation + Pembrolizumab +Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
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| OG001 | Radiation + Pembrolizumab +Dazostinag 0.4 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
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Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first.
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
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Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.4 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
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| OG002 | Radiation + Pembrolizumab +Dazostinag 0.8 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 0.8 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG003 | Radiation + Pembrolizumab +Dazostinag 1.6 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 1.6 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG004 | Radiation + Pembrolizumab +Dazostinag 2.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 2.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG005 | Radiation + Pembrolizumab +Dazostinag 3.5 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 3.5 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG006 | Radiation + Pembrolizumab +Dazostinag 5.0 mg | Participants received image-guided radiation therapy between Day -8 and Day -2. Participants then received pembrolizumab 200 mg, infusion, IV, once on Day 1 of Cycle 1 and then every 3 weeks in each 21-day treatment cycle, followed by dazostinag 5.0 mg infusion, IV, once on Days 1, 8, 15 in each 21-day treatment cycle until disease progression, intolerance to pembrolizumab or TAK-676 or withdrawal of consent, whichever occurred first. |
| OG007 | Radiation Only | Participants received radiation therapy with daily image guidance using a fractionated dose of 8 Gy × 3. |
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