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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001316-29 | EudraCT Number |
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Due to low enrolment of participants
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This study is a sub-study of the master protocol 205801 (NCT03739710). This sub study will assess the clinical activity of novel regimen (Feladilimab plus Ipilimumab) in participants with NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feladilimab plus Ipilimumab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feladilimab | Drug | Feladilimab will be administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary). | Up to 29 weeks |
| Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as febrile neutropenia as defined by CTCAE v5; Grade 4 neutropenia of >7 days in duration; Grade 4 anemia and Grade 3-4 thrombocytopenia with bleeding. Non-hematologic criteria, comprising Grade 4 toxicity; Grade 3 pneumonitis of any duration; Grade 3 toxicity that does not resolve to ≤Grade 1 or baseline within 3 days despite optimal supportive care; any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity Any other toxicity considered to be dose-limiting that occurs beyond four weeks was considered as DLT. Any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT. | Up to 21 days |
| Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Overall Response Rate (ORR) | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline). |
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Inclusion Criteria:
Participants capable of giving signed informed consent/assent.
Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
Participants capable of giving signed informed consent/assent.
Male or female, aged 18 years or older at the time consent is obtained. Participants in Korea must be age 19 years or older at the time consent is obtained.
Participants with histologically or cytologically confirmed diagnosis of NSCLC (squamous or non-squamous) and
Measurable disease, presenting with at least 1 measurable lesion per RECIST 1.1.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.
A tumor tissue sample obtained at any time from the initial diagnosis of NSCLC to time of study entry is mandatory. Although a fresh tumor tissue sample obtained during screening is preferred, archival tumor specimen is acceptable.
Adequate organ function as defined in the protocol.
A male participant must agree to use a highly effective contraception during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions apply:
i) Not a woman of childbearing potential (WOCBP) or ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment.
Life expectancy of at least 12 weeks.
Exclusion Criteria:
Participants who received prior treatment with the following therapies (calculation is based on date of last therapy to date of first dose of study treatment):
Received greater than (>)2 prior lines of therapy for NSCLC, including participants with BRAF molecular alternations.
Invasive malignancy or history of invasive malignancy other than disease under study within the last 2 years, except
Carcinomatous meningitis (regardless of clinical status) and uncontrolled or symptomatic Central nervous system (CNS) metastases.
Major surgery less than or equal to (<=) 28 days of first dose of study treatment.
Autoimmune disease (current or history) or syndrome that required systemic treatment within the past 2 years. Replacement therapies which include physiological doses of corticosteroids for treatment of endocrinopathies (for example, adrenal insufficiency) are not considered systemic treatments.
Receiving systemic steroids (>10 milligrams [mg]) oral prednisone or equivalent) or other immunosuppressive agents within 7 days prior to first dose of study treatment.
Prior allogeneic/autologous bone marrow or solid organ transplantation.
Receipt of any live vaccine within 30 days prior to first dose of study treatment.
Toxicity from previous anticancer treatment that includes:
History (current and past) of idiopathic pulmonary fibrosis, pneumonitis (for past- pneumonitis exclusion only if steroids were required for treatment), interstitial lung disease, or organizing pneumonia.
Recent history (within the past 6 months) of uncontrolled symptomatic ascites, pleural or pericardial effusions.
Recent history (within the past 6 months) of gastrointestinal obstruction that required surgery, acute diverticulitis, inflammatory bowel disease, or intra-abdominal abscess.
History or evidence of cardiac abnormalities within the 6 months prior to enrollment which include
Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypo-albuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.
Active infection requiring systemic therapy <=7 days prior to first dose of study treatment.
Participants with known human immunodeficiency virus infection.
Participants with history of severe hypersensitivity to mAb or hypersensitivity to any of the study treatment(s) or their excipients.
Participants requiring ongoing therapy with a medication that is a strong inhibitor or inducer of the cytochrome P 3A4 (CYP3A4) enzymes.
Any serious and/or unstable pre-existing medical (aside from malignancy), psychiatric disorder, or other condition that could interfere with participant's safety, obtaining informed consent, or compliance to the study procedures in the opinion of the investigator.
Pregnant or lactating female participants.
Participant who is currently participating in or has participated in a study of an investigational device within 4 weeks prior to the first dose of study treatment.
Participants with presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
Participants with positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
Participants with positive hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, and recombinant erythropoietin) within 14 days before the first dose of study intervention.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States | ||
| GSK Investigational Site |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data 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 will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated 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.
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This is a sub-study of the master study NCT03739710. This sub study was terminated due to low enrolment of participants. The study was planned to include two phases - Part 1 and Part 2. No participants from this sub study were enrolled in part 2 as study was early terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Feladilimab + Ipilimumab | Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Feladilimab + Ipilimumab | Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Part 1: Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, or is a congenital anomaly/birth defect, other situations which involved medical or scientific judgment or is associated with liver injury and impaired liver function. SAEs are subset of AEs. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA dictionary). | Safety Population included all participants who received at least one dose of treatment. | Posted | Count of Participants | Participants | Up to 29 weeks |
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All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 29 weeks.
Safety Population included all participants who received at least one dose of treatment.
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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 | Feladilimab + Ipilimumab | Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders | v24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | v24.1 | Systematic Assessment |
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| 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 | May 23, 2022 | Apr 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2021 | May 24, 2025 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Ipilimumab |
| Drug |
Ipilimumab will be administered |
|
| Baseline (Day 1) and up to 29 weeks |
| Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. | Baseline (Day 1) and up to 29 weeks |
| Part 1: Number of Participants With Worst Case Change Post-baseline in Urinalysis Parameters | Urine samples were collected for evaluation of urinalysis parameters using dipstick method. The dipstick test gave results in a semi-quantitative manner. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'Any increase', or 'no changes/decreased' values have been presented. | Baseline (Day 1) and up to 29 weeks |
| Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine | Urine samples were collected from participants to assess urine pH levels. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in urine pH were reported. | Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation) |
| Part 1: Change From Baseline in Specific Gravity of Urine | Urine samples were collected from participants to analyze urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in specific gravity of urine were reported. | Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation) |
| Part 1: Number of Participants With AE Leading to Dose Modifications | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. The number of participants who experienced AE leading to dose modifications were evaluated. | Up to 29 weeks |
| Part 2: Overall Survival | OS is defined as the time from randomization until death due to any cause. | Up to 29 weeks |
| Up to 29 weeks |
| Part 1: Disease Control Rate (DCR) | DCR was defined as the percentage of participants with a confirmed CR + PR at any time, plus stable disease (SD) >=12 weeks. PR was defined as at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. | Up to 29 weeks |
| Part 1: Maximum Concentration (Cmax) and Minimum Concentration (Cmin) | Blood samples were collected for PK analysis. | Up to 29 weeks |
| Part 2: Milestone Survival Rate at 12 and 18 Months | Milestone survival rate is the proportion of participants who are alive at a specific, predefined point in time after a certain event or diagnosis post treatment. | At 12 and 18 months |
| Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) Based on RECIST 1.1 | Complete Response [CR], Partial Response [PR], stable disease [SD], and progressive disease (PD) as assessed by the investigator per IMWG. CR defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm; PR was defined as at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | Up to 29 weeks |
| Part 2: Number of Participants With iRECIST Complete Response (iCR), iRECIST Partial Response (iPR), iRECIST Stable Disease (iSD), iRECIST Confirmed Progressive Disease (iCPD), and iRECIST Unconfirmed Progressive Disease (iUPD) | Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST was to be used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed. | Up to 29 weeks |
| Part 2: Number of Participants With PFS, ORR, DOR, and DCR | PFS defined as time from the date of randomization to the date of disease progression or death, whichever will occurs earlier, per RECIST criteria. ORR defined as the percentage of participants with a confirmed CR or PR at any time per RECIST criteria. DOR defined as the time from first documented evidence of CR or PR until disease progression or death, per RECIST criteria. DCR was defined as the percentage of participants with a confirmed CR + PR at any time, plus stable disease (SD) >=12 weeks. | Up to 29 weeks |
| Part 2: Number of Participants With iPFS, iORR, and iDOR | iPFS defined as time from the date of randomization to the date of disease progression or death, whichever will occurs earlier, per iRECIST criteria. iORR defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iDOR defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. | Up to 29 weeks |
| Part 2: Number of Participants With AEs and SAEs | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were planned to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. | Up to 29 weeks |
| Part 2: Number of Participants With AESI | Number of participants with AESI were planned to be evaluated. | Up to 29 weeks |
| Part 2: Number of Participants With AEs and SAEs Leading to Dose Modification | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. Number of participants with AEs and SAEs leading to dose modification (delays/withdrawal) were planned to be evaluated. | Up to 29 weeks |
| Part 2: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters | Blood samples were to be collected for the analysis of hematology parameters. The laboratory parameters were to be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade were to be defined relative to the Baseline grade. | Up to 29 weeks |
| Part 2: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters | Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade were to be defined relative to the Baseline grade. | Up to 29 weeks |
| Part 2: Number of Participants With Clinically Significant Changes in Vital Signs | Vital signs were planned to be measured after 5 minutes of rest and taken in the same position throughout the study. | Up to 29 weeks |
| Part 2: Maximum Concentration (Cmax) and Minimum Concentration (Cmin) | Blood samples were planned to be collected for PK analysis. | Up to 29 weeks |
| Part 2: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Feladilimab | Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. | Up to 29 weeks |
| Part 2: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Iplimumab | Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. | Up to 29 weeks |
| Brampton |
| Ontario |
| L6R3J7 |
| Canada |
| GSK Investigational Site | Bordeaux | 33076 | France |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Race categories (White and Asian where 0\ | Number | Participants |
|
Participants with Non-Small Cell Lung Cancer (NSCLC) received 24 milligram (mg) Feladilimab first as a 30-minute intravenous (IV) infusion followed by 1 mg/ kilogram (kg) Ipilimumab as IV infusion (started at least 30 minutes following the end of the feladilimab) once every 3 weeks (Q3W). |
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| Primary | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Criteria for dose-limiting toxicity (DLT) included hematologic indicators such as febrile neutropenia as defined by CTCAE v5; Grade 4 neutropenia of >7 days in duration; Grade 4 anemia and Grade 3-4 thrombocytopenia with bleeding. Non-hematologic criteria, comprising Grade 4 toxicity; Grade 3 pneumonitis of any duration; Grade 3 toxicity that does not resolve to ≤Grade 1 or baseline within 3 days despite optimal supportive care; any Grade 2 ocular toxicity requiring systemic steroids, or any ≥ Grade 3 ocular toxicity Any other toxicity considered to be dose-limiting that occurs beyond four weeks was considered as DLT. Any other event which in the judgment of the investigator and GSK Medical Monitor is considered to be a DLT. | Safety Population | Posted | Count of Participants | Participants | Up to 21 days |
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| Primary | Part 1: Number of Participants With Worst-case Change Post-baseline in Hematology Parameters | Blood samples were collected for evaluation of hematology parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. | Safety Population | Posted | Count of Participants | Participants | Baseline (Day 1) and up to 29 weeks |
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| Primary | Part 1: Number of Participants With Worst-case Change Post-baseline in Clinical Chemistry Parameters | Blood samples were collected for evaluation of clinical chemistry parameters. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The number of participants with decreases to low from baseline, changes to normal or no changes from baseline, and increases to high values have been presented. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. | Safety Population. Only those participants with data available in specified categories have been analyzed. | Posted | Count of Participants | Participants | Baseline (Day 1) and up to 29 weeks |
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| Primary | Part 1: Number of Participants With Worst Case Change Post-baseline in Urinalysis Parameters | Urine samples were collected for evaluation of urinalysis parameters using dipstick method. The dipstick test gave results in a semi-quantitative manner. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. The summaries of worst-case change from Baseline with respect to normal range have been presented for only those laboratory tests that are gradable by CTCAE v5.0. The number of participants with 'Any increase', or 'no changes/decreased' values have been presented. | Safety Population. Only those participants with data available in specified categories have been analyzed. | Posted | Count of Participants | Participants | Baseline (Day 1) and up to 29 weeks |
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| Primary | Part 1: Change From Baseline in Potential of Hydrogen (pH) of Urine | Urine samples were collected from participants to assess urine pH levels. pH is measured on a numeric scale ranging from 0 to 14; values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH less than 7 is acidic, and a pH greater than 7 is basic. Normal urine has a slightly acid pH (5.0 - 6.0). Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in urine pH were reported. | Safety Population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Potential of Hydrogen (pH) | Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation) |
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| Primary | Part 1: Change From Baseline in Specific Gravity of Urine | Urine samples were collected from participants to analyze urine specific gravity. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Changes from baseline in specific gravity of urine were reported. | Safety Population. Only those participants with data available at specified time points have been analyzed. | Posted | Mean | Standard Deviation | Kilogram per cubic meter | Baseline (Day 1), week 4, week 7, week 10, week 13 and week 29 (Treatment Discontinuation) |
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| Primary | Part 1: Number of Participants With AE Leading to Dose Modifications | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. The number of participants who experienced AE leading to dose modifications were evaluated. | Safety Population | Posted | Count of Participants | Participants | Up to 29 weeks |
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| Primary | Part 2: Overall Survival | OS is defined as the time from randomization until death due to any cause. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
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| Secondary | Part 1: Overall Response Rate (ORR) | ORR was defined as the percentage of participants who had a confirmed complete response (CR) or confirmed partial response (PR) as their best overall response (BOR) recorded from the date of randomization until disease progression or initiation of new anti-cancer therapy, whichever is earlier based on blinded independent central review (BICR) evaluation criteria in solid tumors (RECIST) version 1.1 (v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters (e.g., percent change from baseline). | Safety Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 29 weeks |
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| Secondary | Part 1: Disease Control Rate (DCR) | DCR was defined as the percentage of participants with a confirmed CR + PR at any time, plus stable disease (SD) >=12 weeks. PR was defined as at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR was defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm. Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. | Safety population. No participants had CR, PR, and SD. | Posted | Up to 29 weeks |
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| Secondary | Part 1: Maximum Concentration (Cmax) and Minimum Concentration (Cmin) | Blood samples were collected for PK analysis. | PK Population included all participants from the ITT Population from whom a blood sample is obtained and analyzed for PK concentration. As a result of the study termination, none of the participants had sufficient samples for analysis. Consequently, data was neither collected nor analyzed, and data will never be analyzed for this outcome measure in the future. | Posted | Up to 29 weeks |
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| Secondary | Part 2: Milestone Survival Rate at 12 and 18 Months | Milestone survival rate is the proportion of participants who are alive at a specific, predefined point in time after a certain event or diagnosis post treatment. | No participants were enrolled in Part 2 as study was terminated. | Posted | At 12 and 18 months |
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| Secondary | Part 2: Number of Participants With Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD) Based on RECIST 1.1 | Complete Response [CR], Partial Response [PR], stable disease [SD], and progressive disease (PD) as assessed by the investigator per IMWG. CR defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 mm; PR was defined as at least 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters; Stable Disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. PD was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With iRECIST Complete Response (iCR), iRECIST Partial Response (iPR), iRECIST Stable Disease (iSD), iRECIST Confirmed Progressive Disease (iCPD), and iRECIST Unconfirmed Progressive Disease (iUPD) | Modified RECIST 1.1 for immune-based therapeutics (iRECIST) is based on RECIST v 1.1 but adapted to account for the unique tumor response seen with immunotherapeutic drugs. iRECIST was to be used to assess tumor response and progression and make treatment decisions. iCR: disappearance of all target lesions; iPR: at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). iCPD: either 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; iSD: stable disease in the absence of CR or PD and iUPD: unconfirmed progressive disease when PD is unconfirmed. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With PFS, ORR, DOR, and DCR | PFS defined as time from the date of randomization to the date of disease progression or death, whichever will occurs earlier, per RECIST criteria. ORR defined as the percentage of participants with a confirmed CR or PR at any time per RECIST criteria. DOR defined as the time from first documented evidence of CR or PR until disease progression or death, per RECIST criteria. DCR was defined as the percentage of participants with a confirmed CR + PR at any time, plus stable disease (SD) >=12 weeks. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With iPFS, iORR, and iDOR | iPFS defined as time from the date of randomization to the date of disease progression or death, whichever will occurs earlier, per iRECIST criteria. iORR defined as the percentage of participants with a confirmed iCR or iPR at any time per iRECIST criteria. iDOR defined as the time from first documented evidence of CR or PR until disease progression or death, per iRECIST criteria. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With AEs and SAEs | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were planned to be coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With AESI | Number of participants with AESI were planned to be evaluated. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With AEs and SAEs Leading to Dose Modification | An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations judged by physician, is associated with liver injury and impaired liver function. AEs and SAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. Number of participants with AEs and SAEs leading to dose modification (delays/withdrawal) were planned to be evaluated. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With Clinically Significant Changes in Hematology Lab Parameters | Blood samples were to be collected for the analysis of hematology parameters. The laboratory parameters were to be graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5. Grade 1 (G1): mild; Grade 2 (G2): moderate; Grade 3 (G3): severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade were to be defined relative to the Baseline grade. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With Clinically Significant Changes in Clinical Chemistry Lab Parameters | Blood samples were to be collected for the analysis of chemistry parameters. The laboratory parameters were to be graded according to CTCAE version 5. G1: mild; G2: moderate; G3: severe or medically significant. Higher grade indicates greater severity and an increase in CTCAE grade were to be defined relative to the Baseline grade. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With Clinically Significant Changes in Vital Signs | Vital signs were planned to be measured after 5 minutes of rest and taken in the same position throughout the study. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Maximum Concentration (Cmax) and Minimum Concentration (Cmin) | Blood samples were planned to be collected for PK analysis. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Feladilimab | Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| Secondary | Part 2: Number of Participants With Post-baseline Positive Anti-drug Antibodies (ADAs) Against Iplimumab | Serum samples were to be collected for the analysis of the presence of ADAs using validated immunoassays. | No participants were enrolled in Part 2 as study was terminated. | Posted | Up to 29 weeks |
|
|
| 4 |
| 8 |
| 3 |
| 8 |
| 8 |
| 8 |
| Pneumonia staphylococcal | Infections and infestations | v24.1 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | v24.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | v24.1 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | v24.1 | Systematic Assessment |
|
| Subacute inflammatory demyelinating polyneuropathy | Nervous system disorders | v24.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | v24.1 | Systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | v24.1 | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | v24.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | v24.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | v24.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | v24.1 | Systematic Assessment |
|
| General physical health deterioration | General disorders | v24.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | v24.1 | Systematic Assessment |
|
| Oral fungal infection | Infections and infestations | v24.1 | Systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | v24.1 | Systematic Assessment |
|
| Hypercalcaemia | Metabolism and nutrition disorders | v24.1 | Systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | v24.1 | Systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | v24.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | v24.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | v24.1 | Systematic Assessment |
|
| Cerebellar ataxia | Nervous system disorders | v24.1 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | v24.1 | Systematic Assessment |
|
| Nervous system disorder | Nervous system disorders | v24.1 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | v24.1 | Systematic Assessment |
|
| Psychomotor retardation | Psychiatric disorders | v24.1 | Systematic Assessment |
|
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | v24.1 | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | v24.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | v24.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | v24.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | v24.1 | 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.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Eosinophils, Decrease to Low |
|
| Eosinophils, Change to Normal or No Change |
|
| Eosinophils, Increase to High |
|
| Erythrocytes, Decrease to Low |
|
| Erythrocytes, Change to Normal or No Change |
|
| Erythrocytes, Increase to High |
|
| Hemoglobin, Decrease to Low |
|
| Hemoglobin, Change to Normal or No Change |
|
| Hemoglobin, Increase to High |
|
| Ery. Mean Corpuscular HGB Concentration (EMCHC), Decrease to Low |
|
| EMCHC, Change to Normal or No Change |
|
| EMCHC, Increase to High |
|
| Ery. Mean Corpuscular Hemoglobin (EMCH), Decrease to Low |
|
| EMCH, Change to Normal or No Change |
|
| EMCH, Increase to High |
|
| Ery. Mean Corpuscular Volume (EMCV), Decrease to Low |
|
| EMCV, Change to Normal or No Change |
|
| EMCV, Increase to High |
|
| Hematocrit, Decrease to Low |
|
| Hematocrit, Change to Normal or No Change |
|
| Hematocrit, Increase to High |
|
| Leukocytes, Decrease to Low |
|
| Leukocytes, Change to Normal or No Change |
|
| Leukocytes, Increase to High |
|
| Lymphocytes, Decrease to Low |
|
| Lymphocytes, Change to Normal or No Change |
|
| Lymphocytes, Increase to High |
|
| Monocytes, Decrease to Low |
|
| Monocytes, Change to Normal or No Change |
|
| Monocytes, Increase to High |
|
| Neutrophils, Decrease to Low |
|
| Neutrophils, Change to Normal or No Change |
|
| Neutrophils, Increase to High |
|
| Platelets, Decrease to Low |
|
| Platelets, Change to Normal or No Change |
|
| Platelets, Increase to High |
|
|
| ALT, Increase to High |
|
|
| Albumin, Decrease to Low |
|
|
| Albumin, Change to Normal or No Change |
|
|
| Albumin, Increase to High |
|
|
| Alkaline Phosphatase (AP), Decrease to Low |
|
|
| AP, Change to Normal or No Change |
|
|
| AP, Increase to High |
|
|
| Aspartate Aminotransferase (AST), Decrease to Low |
|
|
| AST, Change to Normal or No Change |
|
|
| AST, Increase to High |
|
|
| Bilirubin, Decrease to Low |
|
|
| Bilirubin, Change to Normal or No Change |
|
|
| Bilirubin, Increase to High |
|
|
| C Reactive Protein (mg/L), Decrease to Low |
|
|
| C Reactive Protein, Change to Normal or No Change |
|
|
| C Reactive Protein, Increase to High |
|
|
| Calcium, Decrease to Low |
|
|
| Calcium, Change to Normal or No Change |
|
|
| Calcium, Increase to High |
|
|
| Creatinine, Decrease to Low |
|
|
| Creatinine, Change to Normal or No Change |
|
|
| Creatinine, Increase to High |
|
|
| Glucose, Decrease to Low |
|
|
| Glucose, Change to Normal or No Change |
|
|
| Glucose, Increase to High |
|
|
| Lactate Dehydrogenase (LDH), Decrease to Low |
|
|
| LDH, Change to Normal or No Change |
|
|
| LDH, Increase to High |
|
|
| Potassium, Decrease to Low |
|
|
| Potassium, Change to Normal or No Change |
|
|
| Potassium, Increase to High |
|
|
| Protein, Decrease to Low |
|
|
| Protein, Change to Normal or No Change |
|
|
| Protein, Increase to High |
|
|
| Sodium, Decrease to Low |
|
|
| Sodium, Change to Normal or No Change |
|
|
| Sodium, Increase to High |
|
|
| Thyrotropin, Decrease to Low |
|
|
| Thyrotropin, Change to Normal or No Change |
|
|
| Thyrotropin, Increase to High |
|
|
| Triiodothyronine, Free, Decrease to Low |
|
|
| Triiodothyronine, Free, Change to Normal or No Change |
|
|
| Triiodothyronine, Free, Increase to High |
|
|
| Troponin T, Decrease to Low |
|
|
| Troponin T, Change to Normal or No Change |
|
|
| Troponin T, Increase to High |
|
|
| Urea, Decrease to Low |
|
|
| Urea, Change to Normal or No Change |
|
|
| Urea, Increase to High |
|
|
| Title | Measurements |
|---|---|
|
|
| WEEK 7 |
|
|
| WEEK 10 |
|
|
| WEEK 13 |
|
|
| WEEK 29 (Treatment Discontinuation) |
|
|
|
| WEEK 7 |
|
|
| WEEK 10 |
|
|
| WEEK 13 |
|
|
| WEEK 29 (Treatment Discontinuation) |
|
|