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| Name | Class |
|---|---|
| MedImmune LLC | INDUSTRY |
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The purpose of this study is to evaluate if the combination of GSK3359609 and tremelimumab is safe and tolerable (Part 1) and provides significant survival benefit to subjects with relapsed/refractory (R/R) Head and Neck Squamous Cell Carcinomas (HNSCC) to warrant further clinical investigation (Part 2). Part 1 (dose escalation) will enroll subjects with advanced, selected solid tumors. Subjects will receive escalating doses of GSK3359609 and tremelimumab in combination in Part 1. Part 2 is randomized expansion and will enroll subjects with R/R HNSCC who have disease progression after receiving at least 1 platinum-based chemotherapy and at least 1 anti-programmed death receptor protein-1 (PD-1)/anti-programmed death-ligand 1 (PD-L1) therapy, whether in combination or separately. In Part 2, subjects will be randomized in a ratio of 2:1 to receive either GSK3359609 in combination with tremelimumab at the recommended Phase 2 dose or investigators choice of a single-agent standard of care (SOC) therapy including paclitaxel, docetaxel or cetuximab. The total duration of subjects in the study will be approximately 4 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: feladilimab +tremelimumab | Experimental | In Part 1, subjects with advanced selected solid tumors will be enrolled. Subjects will be administered escalating doses of feladilimab and tremelimumab in combination. feladilimab will be administered every 3 weeks and tremelimumab will be administered every 3 weeks for 6 doses and every 12 weeks thereafter. |
|
| Part 2: feladilimab +tremelimumab | Experimental | In Part 2, subjects with R/R HNSCC who have disease progression after receiving at least one platinum-based chemotherapy and at least one anti-PD-1/PD-L1 will be enrolled. Subjects will be administered feladilimab in combination with tremelimumab at recommended Phase 2 dose as determined from Part 1. |
|
| Part 2: SOC | Active Comparator | In Part 2, subjects with R/R HNSCC who have disease progression after receiving at least one platinum-based chemotherapy and at least one anti-PD-1/PD-L1 will be enrolled. Subjects will be administered a single agent SOC therapy of either paclitaxel, docetaxel or cetuximab as per the investigators choice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| feladilimab | Drug | feladilimab is humanized anti-ICOS agonist immunoglobulin G (IgG) 4 monoclonal antibody (mAb), which will be administered as an intravenous (IV) infusion once every 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1 | A DLT is considered by the investigator to be clinically relevant, attributed event within first 28 days of intervention meeting the following criteria of toxicity, Hematologic: Febrile neutropenia, Grade 4 neutropenia of greater than (>) 7 days in duration or requiring Granulocyte- Colony stimulating factor (G-CSF), Grade 4 anemia and Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; Non-hematologic: Grade 4 toxicity, Grade 3 pneumonitis, any greater than or equal to (≥) Grade 2 pneumonitis that does not resolve to less than or equal to (≤ ) Grade 1 within 3 days of the initiation of maximal supportive care, Grade 3 toxicity that does not resolve to Grade 1 or baseline within 3 days despite optimal supportive care and any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity. | Up to 28 days |
| Number of Participants With DLTs According to Severity-Part 1 | The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE. | Up to 28 days |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before. AESIs are defined as events of potential immunologic etiology, including immune related AEs. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate-Part 1 | Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 millimeter [mm]) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per response evaluation criteria in solid tumors (RECIST) version 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38349570 | Background | Hilton JF, Ott PA, Hansen AR, Li Z, Mathew M, Messina CH, Dave V, Ji X, Karpinich NO, Hirschfeld S, Ballas M, Zandberg DP. INDUCE-2: A Phase I/II, open-label, two-part study of feladilimab in combination with tremelimumab in patients with advanced solid tumors. Cancer Immunol Immunother. 2024 Feb 13;73(3):44. doi: 10.1007/s00262-023-03623-z. |
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GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
The results presented are for Part 1 of the study. Part 2 was not initiated due to Sponsor decision to not proceed based on scientific and portfolio priority reasons and lack of adequate efficacy and not due to safety reasons in Part 1. A total of 26 participants were enrolled in this study.
The study was conducted in United States and Canada.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion once every 3 weeks (Q3W) in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once every 12 weeks (Q12W). |
| FG001 | Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| FG002 | Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| FG003 | Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| FG004 | Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| FG005 | Part 2: Feladilimab +Tremelimumab | In Part 2, participants with Head and Neck Squamous Cell Carcinoma (HNSCC) who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti- Programmed death receptor protein-1 (PD-1)/ Programmed death-ligand 1 (PD-L1) therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the Recommended Phase 2 Dose (RP2D) determination. |
| FG006 | Part 2: Standard of Care (SOC) | In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 milligrams per meter square (mg/m^2)), docetaxel (as an IV infusion once Q3W at a dose of 75 mg/m^2) or cetuximab (at a loading dose of 400 mg/m^2 followed by 250 mg/m^2 once weekly) as per the investigator's choice. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs)-Part 1 | A DLT is considered by the investigator to be clinically relevant, attributed event within first 28 days of intervention meeting the following criteria of toxicity, Hematologic: Febrile neutropenia, Grade 4 neutropenia of greater than (>) 7 days in duration or requiring Granulocyte- Colony stimulating factor (G-CSF), Grade 4 anemia and Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia; Non-hematologic: Grade 4 toxicity, Grade 3 pneumonitis, any greater than or equal to (≥) Grade 2 pneumonitis that does not resolve to less than or equal to (≤ ) Grade 1 within 3 days of the initiation of maximal supportive care, Grade 3 toxicity that does not resolve to Grade 1 or baseline within 3 days despite optimal supportive care and any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity. | All Treated Population includes all participants who received at least 1 dose of Tremelimumab or Feladilimab. | Posted | Count of Participants | Participants | Up to 28 days |
|
Non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 to upto 4 years
All Treated Population included participants who received at least 1 dose of SOC or tremelimumab or feladilimab. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac tamponade | Cardiac disorders | MedDra 24.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDra 24.0 | Systematic Assessment |
The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled in the same.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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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 | Sep 20, 2018 | Jun 10, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2020 | Jun 10, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| D002292 | Carcinoma, Renal Cell |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C520704 | tremelimumab |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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In Part 1, dose escalation will occur using a zone based approach. Part 2 will be randomized, parallel group study wherein the subjects will be randomized in a ratio of 2:1 to either recommended Phase 2 dose combination of GSK3359609 and tremelimumab or SOC (paclitaxel, docetaxel or cetuximab).
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| Tremelimumab | Drug | Tremelimumab is humanized anti-CTLA-4 IgG2 mAb, which will be administered as an IV infusion once every 3 weeks for 6 doses, thereafter once every 12 weeks . |
|
| Docetaxel | Drug | Docetaxel is a microtubule stabilizer which will be administered as an IV infusion once every 3 weeks at a dose of 75 milligrams per meter square (mg/m^2). |
|
| Paclitaxel | Drug | Paclitaxel is a microtubule stabilizer which will be administered as an IV infusion once weekly at a dose of 80 mg/m^2. |
|
| Cetuximab | Drug | Cetuximab is a recombinant, human/mouse chimeric anti-estimated glomerular filtration rate (EGFR) mAb. Cetuximab will be administered at a loading dose of 400 mg/m^2 followed by 250 mg/m^2 once weekly. |
|
| Up to 4 years |
| Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | The number of participants with AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized. | Up to 4 years |
| Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE. | Up to 4 years |
| Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized. | Up to 4 years |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP and DBP were measured after 5 minutes of rest for the participant. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Temperature-Part 1 | Temperature was measured after 5 minutes of rest for the participant. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Pulse Rate-Part 1 | Pulse rate was measured after 5 minutes of rest for the participant. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Respiratory Rate-Part 1 | Respiratory rate was measured after 5 minutes of rest for the participant. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Oxygen Saturation-Part 1 | Oxygen saturation was measured using pulse oximeter after 5 minutes of rest for the participant. | Baseline (Day 1) and Week 4 |
| Number of Participants With Electrocardiogram (ECG) Findings | Single 12-lead ECG was obtained using an automated ECG machine. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator. | Baseline (Pre dose, Day 1) and up to 4 Years |
| Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Blood samples were collected to assess change from Baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet counts. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Hemoglobin Level-Part 1 | Blood samples were collected to assess change from baseline in hemoglobin level. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Hematocrit Level-Part 1 | Blood samples were collected to assess change from baseline in hematocrit level. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Erythrocytes Count-Part 1 | Blood samples were collected to assess change from baseline in Erythrocytes count. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Albumin and Total Protein Levels-Part 1 | Blood samples were collected to assess change from Baseline in albumin and total protein levels. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Blood samples were collected to assess change from baseline in creatinine and bilirubin levels. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | Blood samples were collected to assess change from baseline in ALT, AST ALP, LDH levels. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Amylase and Lipase Levels-Part 1 | Blood samples were collected to assess change from baseline in amylase and lipase levels. | Baseline (Day 1) and week 4 |
| Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Blood samples were collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Specific Gravity of Urine-Part 1 | Urine samples were collected to assess change from baseline in specific gravity of urine. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Urine samples were collected to assess change from baseline in pH of urine. | Baseline (Day 1) and Week 4 |
| Number of Participants With Abnormal Urinalysis Parameters-Part 1 | The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose in urine. Positive test results were considered as abnormal. Number of participants with positive test results have been summarized. | Week 4 |
| Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 | Blood samples were collected to assess change from Baseline in TSH. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Free Triiodothyronine (T3)-Part 1 | Blood samples were collected to assess change from Baseline in free T3. | Baseline (Day 1) and Week 4 |
| Change From Baseline in Free Thyroxine (T4)-Part 1 | Blood samples were collected to assess change from baseline in free T4. | Baseline (Day 1) and Week 4 |
| Overall Survival-Part 2 | For participants in Part 2, overall survival is defined as time from the date of randomization to the date of death due to any cause. | Up to 4 years |
| Up to 4 years |
| Overall Response Rate-Part 2 | Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per RECIST version 1.1. | Up to 4 years |
| Disease Control Rate-Part 1 | Disease control rate is defined as percentage of subjects with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or at least 18 weeks of stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) as per RECIST version 1.1. | Up to 4 years |
| Disease Control Rate-Part 2 | Disease control rate is defined as percentage of subjects with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or at least 18 weeks of stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) as per RECIST version 1.1. | Up to 4 years |
| Progression Free Survival-Part 2 | For Part 2, progression free survival duration is defined as the time from the date of randomization to first documented evidence of disease progression (At least a 20% increase in the sum of diameters of target lesions and In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm) or death (regardless of cause of death), whichever comes first as per RECIST version 1.1. | Up to 4 years |
| Time to Response-Part 2 | Time to response is defined as the time from the first dose to the first documented evidence of complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) for participants with a confirmed CR or PR as per RECIST version 1.1. | Up to 4 years |
| Duration of Response-Part 2 | Duration of response is defined as time from the first documented evidence of response until the first documented sign of disease progression or death among participants who achieve a response (CR [Disappearance of all target lesions. Any pathological lymph nodes {whether target or non-target} must have reduction in short axis to <10 mm or PR [At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters] as per RECIST version 1.1).](streamdown:incomplete-link) | Up to 4 years |
| Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
| Cmax of Tremelimumab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
| Cmax of Feladilimab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1 |
| Cmax of Tremelimumab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1 |
| Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
| Cmin of Tremelimumab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
| Cmin of Feladilimab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1 |
| Cmin of Tremelimumab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1 |
| Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
| AUC(0-t) of Tremelimumab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
| AUC(0-t) of Feladilimab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25, and 4 hours post-infusion at Week 1 |
| AUC(0-t) of Tremelimumab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1 |
| Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Serum samples were collected and tested for the presence of antibodies to feladilimab. | Pre-dose at Week 4, 7, 10 and 13 |
| Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Serum samples were collected and tested for the presence of antibodies to tremelimumab. | Pre-dose at Week 1, 4, 7, 10 and 13 |
| Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 2 | Serum samples will be collected and tested for the presence of antibodies to feladilimab. | Up to 2.5 years |
| Change From Baseline in Free T4-Part 2 | Blood samples will be collected to assess change from baseline in free T4. | Baseline and up to 2 years |
| Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 2 | Serum samples will be collected and tested for the presence of antibodies to tremelimumab. | Up to 2.5 years |
| Number of Participants With AEs, SAEs and AESI-Part 2 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before. AESIs are defined as events of potential immunologic etiology, including immune related AEs. | Up to 4 years |
| Number of Participants With AEs, SAEs, AESIs Based on Severity-Part 2 | The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE | Up to 4 years |
| Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 2 | The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were planned to be summarized. | Up to 4 years |
| Change From Baseline in SBP and DBP-Part 2 | SBP and DBP will be measured after 5 minutes of rest for the participant. | Baseline and up to 2 years |
| Change From Baseline in Temperature-Part 2 | Temperature will be measured after 5 minutes of rest for the participant. | Baseline and up to 2 years |
| Change From Baseline in Pulse Rate-Part 2 | Pulse rate will be measured after 5 minutes of rest for the participant. | Baseline and up to 2 years |
| Change From Baseline in Respiratory Rate-Part 2 | Respiratory rate will be measured after 5 minutes of rest for the participant. | Baseline and up to 2 years |
| Change From Baseline in Oxygen Saturation-Part 2 | Oxygen saturation will be measured using pulse oximetry after 5 minutes of rest for the participant. | Baseline and up to 2 years |
| Change From Baseline in ECG Measurement-Part 2 | Single 12-lead ECG will be obtained using an automated ECG machine. | Baseline (Pre-dose) up to 2 years |
| Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 2 | Blood samples will be collected to assess change from baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count. | Baseline and up to 2 years |
| Change From Baseline in Hemoglobin Level-Part 2 | Blood samples will be collected to assess change from baseline in hemoglobin level. | Baseline and up to 2 years |
| Change From Baseline in Hematocrit Level-Part 2 | Blood samples will be collected to assess change from baseline in hematocrit level. | Baseline and up to 2 years |
| Change From Baseline in Erythrocytes Count-Part 2 | Blood samples will be collected to assess change from Baseline in erythrocytes count. | Baseline and up to 2 years |
| Change From Baseline in Albumin and Total Protein Levels-Part 2 | Blood samples will be collected to assess change from baseline in albumin and total protein levels. | Baseline and up to 2 years |
| Change From Baseline in Creatinine and Bilirubin Levels-Part 2 | Blood samples will be collected to assess change from baseline in creatinine and bilirubin levels. | Baseline and up to 2 years |
| Change From Baseline in ALT, AST, ALP, LDH Levels-Part 2 | Blood samples will be collected to assess change from baseline in ALT, AST ALP, LDH, amylase and lipase levels. | Baseline and up to 2 years |
| Change From Baseline in Amylase and Lipase Levels-Part 2 | Blood samples were collected to assess change from baseline in amylase and lipase levels. | Baseline and up to 2 years |
| Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels -Part 2 | Blood samples will be collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline. | Baseline and up to 2 years |
| Change From Baseline in Specific Gravity of Urine-Part 2 | Urine samples will be collected to assess change from Baseline in specific gravity of urine. | Baseline and up to 2 years |
| Change From Baseline in pH of Urine-Part 2 | Urine samples will be collected to assess change from baseline in pH of urine. | Baseline and up to 2 years |
| Number of Participants With Abnormal Urinalysis Parameters-Part 2 | The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose. Positive test results were considered as abnormal. Number of participants with positive test results were planned to be summarized. | Up to 2 years |
| Change From Baseline in TSH-Part 2 | Blood samples will be collected to assess change from Baseline in TSH. | Baseline and up to 2 years |
| Change From Baseline in Free T3-Part 2 | Blood samples will be collected to assess change from baseline in free T3. | Baseline and up to 2 years |
| New York |
| New York |
| 10016-4744 |
| United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15232 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Melbourne | Victoria | 3000 | Australia |
| GSK Investigational Site | Ottawa | Ontario | K1H 8L6 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 2M9 | Canada |
| Withdrawal by Subject |
|
| Study Terminated by Sponsor |
|
| BG001 | Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| BG002 | Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| BG003 | Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| BG004 | Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| BG005 | Part 2: Feladilimab + Tremelimumab | In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination. |
| BG006 | Part 2: Standard of Care (SOC) | In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m^2) or cetuximab (at a loading dose of 400 mg/m^2 followed by 250 mg/m^2 once weekly) as per the investigator's choice. |
| BG007 | Total | Total of all reporting groups |
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG000 | Part 1: Feladilimab (GSK3359609) 8 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| OG001 | Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| OG002 | Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| OG003 | Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
| OG004 | Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. |
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| Primary | Number of Participants With DLTs According to Severity-Part 1 | The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE. | All Treated Population | Posted | Count of Participants | Participants | Up to 28 days |
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| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)-Part 1 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before. AESIs are defined as events of potential immunologic etiology, including immune related AEs. | All Treated Population | Posted | Count of Participants | Participants | Up to 4 years |
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| Primary | Number of Participant With AE/SAE/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | The number of participants with AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized. | All Treated Population | Posted | Count of Participants | Participants | Up to 4 years |
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| Primary | Number of Participants With AEs, SAEs, AESIs According to Severity - Part 1 | The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE. | All Treated Population | Posted | Count of Participants | Participants | Up to 4 years |
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| Primary | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 1 | The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were summarized. | All Treated Population | Posted | Count of Participants | Participants | Up to 4 years |
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| Primary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)-Part 1 | SBP and DBP were measured after 5 minutes of rest for the participant. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Millimeters of mercury (mmHg) | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Temperature-Part 1 | Temperature was measured after 5 minutes of rest for the participant. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Celsius (C) | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Pulse Rate-Part 1 | Pulse rate was measured after 5 minutes of rest for the participant. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | beats/minute | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Respiratory Rate-Part 1 | Respiratory rate was measured after 5 minutes of rest for the participant. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | breaths/ minute | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Oxygen Saturation-Part 1 | Oxygen saturation was measured using pulse oximeter after 5 minutes of rest for the participant. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Percentage (%) of Oxygen | Baseline (Day 1) and Week 4 |
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| Primary | Number of Participants With Electrocardiogram (ECG) Findings | Single 12-lead ECG was obtained using an automated ECG machine. ECG findings were categorized as: normal, abnormal - clinically significant (CS), or abnormal - not clinically significant (NCS), as determined by the investigator. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Count of Participants | Participants | Baseline (Pre dose, Day 1) and up to 4 Years |
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| Primary | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 1 | Blood samples were collected to assess change from Baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet counts. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | 10^9 cells/liter | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Hemoglobin Level-Part 1 | Blood samples were collected to assess change from baseline in hemoglobin level. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | grams/liter | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Hematocrit Level-Part 1 | Blood samples were collected to assess change from baseline in hematocrit level. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | fraction of 1 | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Erythrocytes Count-Part 1 | Blood samples were collected to assess change from baseline in Erythrocytes count. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | 10^12 cells/liter | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Albumin and Total Protein Levels-Part 1 | Blood samples were collected to assess change from Baseline in albumin and total protein levels. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | grams/Liter | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Creatinine and Bilirubin Levels-Part 1 | Blood samples were collected to assess change from baseline in creatinine and bilirubin levels. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | micromoles/ Liter | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP), Lactate Dehydrogenase (LDH) Levels-Part 1 | Blood samples were collected to assess change from baseline in ALT, AST ALP, LDH levels. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | International Units/milliliter | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Amylase and Lipase Levels-Part 1 | Blood samples were collected to assess change from baseline in amylase and lipase levels. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Units/milliliter | Baseline (Day 1) and week 4 |
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| Primary | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels-Part 1 | Blood samples were collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | millimoles/Liter | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Specific Gravity of Urine-Part 1 | Urine samples were collected to assess change from baseline in specific gravity of urine. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | Ratio | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Potential of Hydrogen (pH) of Urine-Part 1 | Urine samples were collected to assess change from baseline in pH of urine. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Mean | Standard Deviation | pH | Baseline (Day 1) and Week 4 |
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| Primary | Number of Participants With Abnormal Urinalysis Parameters-Part 1 | The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose in urine. Positive test results were considered as abnormal. Number of participants with positive test results have been summarized. | All Treated Population. Only those participants with data available at the specified data points were analyzed. | Posted | Count of Participants | Participants | Week 4 |
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| Primary | Change From Baseline in Thyroid Stimulating Hormone (TSH) or Thyrotropin-Part 1 | Blood samples were collected to assess change from Baseline in TSH. | All Treated Population. Only those participants with data available at specified time points were analyzed. | Posted | Mean | Standard Deviation | milliUnits/Liter | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Free Triiodothyronine (T3)-Part 1 | Blood samples were collected to assess change from Baseline in free T3. | All Treated Population. Only those participants with data available at specified time points were analyzed. | Posted | Mean | Standard Deviation | Picomoles per liter | Baseline (Day 1) and Week 4 |
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| Primary | Change From Baseline in Free Thyroxine (T4)-Part 1 | Blood samples were collected to assess change from baseline in free T4. | All Treated Population. Only those participants with data available at specified time points were analyzed. | Posted | Mean | Standard Deviation | Picomoles per liter | Baseline (Day 1) and Week 4 |
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| Primary | Overall Survival-Part 2 | For participants in Part 2, overall survival is defined as time from the date of randomization to the date of death due to any cause. | Intent-To-Treat population includes all participants in Part 2 who were planned to be randomized in the trial. Part 1 participants that were dosed at the dose level chosen for expansion in Part 2 were planned to be excluded from the Part 2 ITT. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 4 years |
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| Secondary | Overall Response Rate-Part 1 | Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 millimeter [mm]) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per response evaluation criteria in solid tumors (RECIST) version 1.1. | All Treated Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 4 years |
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| Secondary | Overall Response Rate-Part 2 | Overall response rate is defined as percentage of participants with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) at any time as per RECIST version 1.1. | Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 4 years |
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| Secondary | Disease Control Rate-Part 1 | Disease control rate is defined as percentage of subjects with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or at least 18 weeks of stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) as per RECIST version 1.1. | All Treated Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 4 years |
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| Secondary | Disease Control Rate-Part 2 | Disease control rate is defined as percentage of subjects with confirmed complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) or at least 18 weeks of stable disease (Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD) as per RECIST version 1.1. | Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 4 years |
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| Secondary | Progression Free Survival-Part 2 | For Part 2, progression free survival duration is defined as the time from the date of randomization to first documented evidence of disease progression (At least a 20% increase in the sum of diameters of target lesions and In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm) or death (regardless of cause of death), whichever comes first as per RECIST version 1.1. | Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 4 years |
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| Secondary | Time to Response-Part 2 | Time to response is defined as the time from the first dose to the first documented evidence of complete response (Disappearance of all target lesions. Any pathological lymph nodes [whether target or non-target] must have reduction in short axis to <10 mm) or partial response (At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) for participants with a confirmed CR or PR as per RECIST version 1.1. | Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 4 years |
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| Secondary | Duration of Response-Part 2 | Duration of response is defined as time from the first documented evidence of response until the first documented sign of disease progression or death among participants who achieve a response (CR [Disappearance of all target lesions. Any pathological lymph nodes {whether target or non-target} must have reduction in short axis to <10 mm or PR [At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters] as per RECIST version 1.1).](streamdown:incomplete-link) | Intent-To-Treat Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 4 years |
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| Secondary | Maximum Observed Plasma Concentration (Cmax) of Feladilimab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic (PK) Population includes all participants from the All Treated population for whom at least one PK sample was obtained, analysed and measurable. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
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| Secondary | Cmax of Tremelimumab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/milliliter | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
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| Secondary | Cmax of Feladilimab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1 |
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| Secondary | Cmax of Tremelimumab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25; and 4 hours post-infusion at Week 1 |
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| Secondary | Minimum Observed Plasma Concentration (Cmin) of Feladilimab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/ milliliter | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
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| Secondary | Cmin of Tremelimumab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms/ milliliter | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
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| Secondary | Cmin of Feladilimab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1 |
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| Secondary | Cmin of Tremelimumab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1 |
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| Secondary | Area Under the Plasma Concentration-time Curve (AUC[0-t]) of Feladilimab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. Only those participants with data available at specified time points has been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliLiter | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
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| Secondary | AUC(0-t) of Tremelimumab-Part 1 | Blood samples were collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. Only those participants with data available at specified time points has been analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanograms*hours/milliLiter | Pre-dose, end of infusion and 4 hours post dose at Day 1 |
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| Secondary | AUC(0-t) of Feladilimab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment. | Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, 19, 25, then every 12 weeks for 2 years; end of infusion at Weeks 1, 19 and 25, and 4 hours post-infusion at Week 1 |
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| Secondary | AUC(0-t) of Tremelimumab-Part 2 | Blood samples were planned to be collected at indicated time points for pharmacokinetic assessment | Pharmacokinetic Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Pre-dose at Weeks 1, 2, 4, 7, 10, 13, 16, then every 12 weeks for 2 years; end of infusion; and 4 hours post-infusion at Week 1 |
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| Secondary | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 1 | Serum samples were collected and tested for the presence of antibodies to feladilimab. | All Treated population. Only those participants with data available at specified time points has been analyzed. Number of participants analyzed refers to the analysis population. Number analyzed at each time point refers to the participants for whom screening assays were conducted. | Posted | Count of Participants | Participants | Pre-dose at Week 4, 7, 10 and 13 |
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| Secondary | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 1 | Serum samples were collected and tested for the presence of antibodies to tremelimumab. | All Treated population. Only those participants with data available at specified time points has been analyzed. Number of participants analyzed refers to the analysis population. Number analyzed at each time point refers to the participants for whom screening assays were conducted. | Posted | Count of Participants | Participants | Pre-dose at Week 1, 4, 7, 10 and 13 |
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| Secondary | Number of Participants With Anti-drug Antibodies Against Feladilimab-Part 2 | Serum samples will be collected and tested for the presence of antibodies to feladilimab. | ITT Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 2.5 years |
|
|
| Secondary | Change From Baseline in Free T4-Part 2 | Blood samples will be collected to assess change from baseline in free T4. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Number of Participants With Anti-drug Antibodies Against Tremelimumab-Part 2 | Serum samples will be collected and tested for the presence of antibodies to tremelimumab. | ITT Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 2.5 years |
|
|
| Secondary | Number of Participants With AEs, SAEs and AESI-Part 2 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect and important medical events may jeopardize the subject or may require medical or surgical intervention/SOC to prevent one of the other outcomes mentioned before. AESIs are defined as events of potential immunologic etiology, including immune related AEs. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 4 years |
|
|
| Secondary | Number of Participants With AEs, SAEs, AESIs Based on Severity-Part 2 | The severity of all toxicities were graded using the National Cancer Institute- Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1: Mild reaction; infusion interruption not indicated; intervention not indicated; Grade 2: Requires therapy or infusion interruption but responds promptly to symptomatic treatment or prophylactic medications indicated for ≤24 hours; Grade 3: Prolonged (i.e., not rapidly responsive to symptomatic medication and/or brief interruption of infusion) or recurrence of symptoms following initial improvement; hospitalization indicated for other clinical sequelae; Grade 4: Life-threatening; pressor or ventilatory support indicated; Grade 5: Death related to AE | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 4 years |
|
|
| Secondary | Number of Participants With Severe- AEs/SAEs/DLTs Leading to Dose Modifications/Delays/Withdrawals-Part 2 | The number of participants with severe- AE/SAE/DLTs leading to dose modifications/delays/withdrawals were planned to be summarized. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 4 years |
|
|
| Secondary | Change From Baseline in SBP and DBP-Part 2 | SBP and DBP will be measured after 5 minutes of rest for the participant. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Temperature-Part 2 | Temperature will be measured after 5 minutes of rest for the participant. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Pulse Rate-Part 2 | Pulse rate will be measured after 5 minutes of rest for the participant. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Respiratory Rate-Part 2 | Respiratory rate will be measured after 5 minutes of rest for the participant. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Oxygen Saturation-Part 2 | Oxygen saturation will be measured using pulse oximetry after 5 minutes of rest for the participant. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in ECG Measurement-Part 2 | Single 12-lead ECG will be obtained using an automated ECG machine. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline (Pre-dose) up to 2 years |
|
|
| Secondary | Change From Baseline in Neutrophil, Lymphocyte, Monocyte, Eosinophil, Basophil and Platelet Count-Part 2 | Blood samples will be collected to assess change from baseline in neutrophil, lymphocyte, monocyte, eosinophil, basophil and platelet count. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Hemoglobin Level-Part 2 | Blood samples will be collected to assess change from baseline in hemoglobin level. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Hematocrit Level-Part 2 | Blood samples will be collected to assess change from baseline in hematocrit level. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Erythrocytes Count-Part 2 | Blood samples will be collected to assess change from Baseline in erythrocytes count. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Albumin and Total Protein Levels-Part 2 | Blood samples will be collected to assess change from baseline in albumin and total protein levels. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Creatinine and Bilirubin Levels-Part 2 | Blood samples will be collected to assess change from baseline in creatinine and bilirubin levels. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in ALT, AST, ALP, LDH Levels-Part 2 | Blood samples will be collected to assess change from baseline in ALT, AST ALP, LDH, amylase and lipase levels. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Amylase and Lipase Levels-Part 2 | Blood samples were collected to assess change from baseline in amylase and lipase levels. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Urea, Glucose, Potassium, Sodium and Calcium Levels -Part 2 | Blood samples will be collected to assess change in levels of urea, glucose, potassium, sodium and calcium from baseline. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Specific Gravity of Urine-Part 2 | Urine samples will be collected to assess change from Baseline in specific gravity of urine. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in pH of Urine-Part 2 | Urine samples will be collected to assess change from baseline in pH of urine. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Number of Participants With Abnormal Urinalysis Parameters-Part 2 | The dipstick test gives positive or negative results for protein, ketones, occult blood and glucose. Positive test results were considered as abnormal. Number of participants with positive test results were planned to be summarized. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Up to 2 years |
|
|
| Secondary | Change From Baseline in TSH-Part 2 | Blood samples will be collected to assess change from Baseline in TSH. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| Secondary | Change From Baseline in Free T3-Part 2 | Blood samples will be collected to assess change from baseline in free T3. | All Treated Population. The sponsor made the decision to not continue the study at the end of Part 1 based on the totality of available data due to lack of efficacy and not due to safety. Hence Part 2 was not initiated and participants were not enrolled. | Posted | Baseline and up to 2 years |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Part 1: Feladilimab 24 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. | 0 | 1 | 0 | 1 | 1 | 1 |
| EG002 | Part 1: Feladilimab 8 mg + Tremelimumab 225 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 8 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. | 0 | 5 | 3 | 5 | 5 | 5 |
| EG003 | Part 1: Feladilimab 80 mg + Tremelimumab 75 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 80 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 75 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. | 0 | 3 | 3 | 3 | 3 | 3 |
| EG004 | Part 1: Feladilimab 24 mg + Tremelimumab 225 mg | In Part 1, participants with advanced, selected solid tumors were enrolled. Participants were administered 24 mg Feladilimab first as a 30-minute IV infusion once Q3W in combination with 225 mg tremelimumab as an IV infusion over 60 minutes beginning at least 1 hour and no more than 2 hours once Q3W for 6 doses followed by once Q12W. | 1 | 16 | 6 | 16 | 16 | 16 |
| EG005 | Part 2: Feladilimab + Tremelimumab | In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/ PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with Feladilimab and Tremelimumab as an IV infusion after the RP2D determination. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG006 | Part 2: Standard of Care (SOC) | In Part 2, participants with HNSCC who have progressed after receiving at least 1 platinum-based chemotherapy and at least one anti-PD-1/PD-L1 therapy, whether in combination or separately were planned to be enrolled. Participants were planned to be administered with a single agent SOC therapy of either paclitaxel (as an IV infusion once weekly at a dose of 80 mg/m^2), docetaxel (as an IV infusion once every 3 weeks at a dose of 75 mg/m^2) or cetuximab (at a loading dose of 400 mg/m^2 followed by 250 mg/m^2 once weekly) as per the investigator's choice. | 0 | 0 | 0 | 0 | 0 | 0 |
| Colitis | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Death | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Abscess neck | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Bacteraemia | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.0 | Systematic Assessment |
|
| Hydrocephalus | Nervous system disorders | MedDra 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDra 24.0 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDra 24.0 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDra 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDra 24.0 | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDra 24.0 | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | MedDra 24.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDra 24.0 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDra 24.0 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDra 24.0 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDra 24.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Hyperchlorhydria | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Salivary duct inflammation | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Swollen tongue | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Chills | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Malaise | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Pain | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Physical deconditioning | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDra 24.0 | Systematic Assessment |
|
| Hepatitis | Hepatobiliary disorders | MedDra 24.0 | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Catheter site infection | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Fungal infection | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Oesophageal candidiasis | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Oral candidiasis | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Rash pustular | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDra 24.0 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDra 24.0 | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| International normalised ratio increased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDra 24.0 | Systematic Assessment |
|
| Acidosis | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDra 24.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDra 24.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDra 24.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDra 24.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDra 24.0 | Systematic Assessment |
|
| Neuralgia | Nervous system disorders | MedDra 24.0 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDra 24.0 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDra 24.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDra 24.0 | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDra 24.0 | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDra 24.0 | Systematic Assessment |
|
| Chronic kidney disease | Renal and urinary disorders | MedDra 24.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDra 24.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDra 24.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Vitiligo | Skin and subcutaneous tissue disorders | MedDra 24.0 | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDra 24.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDra 24.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDra 24.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 5 |
|
| SAEs |
|
| AESIs |
|
| Any Aes-Dose Delay |
|
| Any Aes-Dose Withdrawal |
|
| Any SAEs-Dose Modification |
|
| Any SAEs-Dose Delay |
|
| Any SAEs-Dose Withdrawal |
|
| Any DLTs-Dose Modification |
|
| Any DLTs-Dose Delay |
|
| Any DLTs-Dose Withdrawal |
|
| Grade 2: AEs |
|
| Grade 3: AEs |
|
| Grade 4: AEs |
|
| Grade 5: AEs |
|
| Grade 1: SAEs |
|
| Grade 2: SAEs |
|
| Grade 3: SAEs |
|
| Grade 4: SAEs |
|
| Grade 5: SAEs |
|
| Grade 1: AESI |
|
| Grade 2: AESI |
|
| Grade 3: AESI |
|
| Grade 4: AESI |
|
| Grade 5: AESI |
|
| Any Severe Aes-Dose Delay |
|
| Any Severe Aes-Dose Withdrawal |
|
| Any Severe SAEs-Dose Modification |
|
| Any Severe SAEs-Dose Delay |
|
| Any Severe SAEs-Dose Withdrawal |
|
| Any Severe DLTs-Dose Modification |
|
| Any Severe DLTs-Dose Delay |
|
| Any Severe DLTs-Dose Withdrawal |
|
|
| SBP, Week 4 |
|
|
| DBP, Baseline (Day 1) |
|
|
| DBP, Week 4 |
|
|
|
| Week 4 |
|
|
|
| Week 4 |
|
|
|
| Week 4 |
|
|
|
| Week 4 |
|
|
|
| Worst case Post-Baseline |
|
|
|
| Basophils, Week 4 |
|
|
| Eosinophils, Baseline (Day 1) |
|
|
| Eosinophils, Week 4 |
|
|
| Lymphocytes, Baseline (Day 1) |
|
|
| Lymphocytes, Week 4 |
|
|
| Monocytes, Baseline (Day 1) |
|
|
| Monocytes, Week 4 |
|
|
| Neutrophils, Baseline (Day 1) |
|
|
| Neutrophils, Week 4 |
|
|
| Platelets, Baseline (Day 1) |
|
|
| Platelets, Week 4 |
|
|
|
| Week 4 |
|
|
|
| Week 4 |
|
|
|
| Week 4 |
|
|
|
| Albumin, Week 4 |
|
|
| Protein, Baseline (Day 1) |
|
|
| Protein, Week 4 |
|
|
|
| Bilirubin, Week 4 |
|
|
| Creatinine, Baseline (Day 1) |
|
|
| Creatinine, Week 4 |
|
|
|
| ALP, Week 4 |
|
|
| ALT, Baseline (Day 1) |
|
|
| ALT, Week 4 |
|
|
| AST, Baseline (Day 1) |
|
|
| AST, Week 4 |
|
|
| LDH, Baseline (Day 1) |
|
|
| LDH, Week 4 |
|
|
|
| Amylase, Week 4 |
|
|
| Lipase, Baseline (Day 1) |
|
|
| Lipase, Week 4 |
|
|
|
| Glucose, Week 4 |
|
|
| Calcium, Baseline (Day 1) |
|
|
| Calcium, Week 4 |
|
|
| Potassium, Baseline (Day 1) |
|
|
| Potassium, Week 4 |
|
|
| Sodium, Baseline (Day 1) |
|
|
| Sodium, Week 4 |
|
|
| Urea, Baseline (Day 1) |
|
|
| Urea, Week 4 |
|
|
|
| Week 4 |
|
|
|
| Week 4 |
|
|
| Dip stick test for Protein |
|
| Dip stick test for Occult Blood |
|
| Dip stick test for Ketones |
|
|
| Week 4 |
|
|
|
| Week 4 |
|
|
| Week 4 |
|
|
|
| Week 7 |
|
|
| Week 10 |
|
|
| Week 13 |
|
|
|
| Week 4 |
|
|
| Week 7 |
|
|
| Week 10 |
|
|
| Week 13 |
|
|
| Abnormal CS |
|
| Abnormal NCS |
|