Description:
The purpose of this study is to assess the safety profile of nivolumab plus relatlimab in
combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus
relatlimab in combination with PDCT improves progression free survival (PFS) when compared to
nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small
cell lung cancer (NSCLC).
Title
- Brief Title: A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
- Official Title: A Phase 2 Randomized Double-blind Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
Clinical Trial IDs
- ORG STUDY ID:
CA224-104
- SECONDARY ID:
2020-004026-31
- SECONDARY ID:
U1111-1256-8115
- NCT ID:
NCT04623775
Conditions
- Non-small Cell Lunch Cancer
- Recurrent Non-small Cell Lung Cancer
- Metastatic Non-small Cell Lung Cancer
Interventions
Drug | Synonyms | Arms |
---|
Nivolumab | | Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) |
Relatlimab | | Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) |
Carboplatin | | Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) |
Cisplatin | | Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) |
Paclitaxel | | Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) |
Nab-Paclitaxel | | Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) |
Pemetrexed | | Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) |
Purpose
The purpose of this study is to assess the safety profile of nivolumab plus relatlimab in
combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus
relatlimab in combination with PDCT improves progression free survival (PFS) when compared to
nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small
cell lung cancer (NSCLC).
Trial Arms
Name | Type | Description | Interventions |
---|
Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT)) | Experimental | | - Nivolumab
- Relatlimab
- Carboplatin
- Cisplatin
- Paclitaxel
- Nab-Paclitaxel
- Pemetrexed
|
Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT)) | Experimental | | - Nivolumab
- Relatlimab
- Carboplatin
- Cisplatin
- Paclitaxel
- Nab-Paclitaxel
- Pemetrexed
|
Part 2: Arm C (Nivolumab + Relatlimab Dose 1 or Dose 2 + PDCT) | Experimental | | - Nivolumab
- Relatlimab
- Carboplatin
- Cisplatin
- Paclitaxel
- Nab-Paclitaxel
- Pemetrexed
|
Part 2: Arm D (Nivolumab + Placebo + PDCT) | Placebo Comparator | | - Nivolumab
- Carboplatin
- Cisplatin
- Paclitaxel
- Nab-Paclitaxel
- Pemetrexed
|
Eligibility Criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com
Inclusion Criteria:
- Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous
(SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th
International Association for the Study of Lung Cancer Classification) or recurrent
disease following multi-modal therapy for locally advanced disease
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or
equal to 1 at screening and confirmed prior to randomization
- Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI)
per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria
- No prior systemic anti-cancer treatment (including epidermal growth factor receptor
(EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for
advanced or metastatic disease
Exclusion Criteria:
- Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma
proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy
- Untreated CNS metastases
- Leptomeningeal metastases (carcinomatous meningitis)
- Concurrent malignancy requiring treatment or history of prior malignancy active within
2 years prior to randomization (ie, participants with a history of prior malignancy
are eligible if treatment was completed at least 2 years before randomization and the
participant has no evidence of disease)
- Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed
death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic
T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug
specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Treatment-related adverse events (TRAEs) leading to discontinuation within 12 weeks after the first dose |
Time Frame: | Up to 10 months, from first participant's first dose |
Safety Issue: | |
Description: | Part 1 |
Secondary Outcome Measures
Measure: | Incidence of TRAEs leading to discontinuation |
Time Frame: | Up to 10 months, 30 days from participant's last dose |
Safety Issue: | |
Description: | Part 1 |
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Up to 10 months, 30 days from participant's last dose |
Safety Issue: | |
Description: | Part 1 |
Measure: | Incidence of Serious Adverse Events (SAEs) |
Time Frame: | Up to 10 months, 30 days from participant's last dose |
Safety Issue: | |
Description: | Part 1 |
Measure: | Incidence of select Adverse Events (AEs) |
Time Frame: | Up to 10 months, 30 days from participant's last dose |
Safety Issue: | |
Description: | Part 1 |
Measure: | PFS per RECIST v1.1 by BICR in biomarker subgroups |
Time Frame: | Until progression, up to 21 months |
Safety Issue: | |
Description: | Part 2 |
Measure: | Overall response rate (ORR) per RECIST v1.1 by BICR |
Time Frame: | Up to 21 months |
Safety Issue: | |
Description: | Part 2 |
Measure: | Incidence of Adverse Events (AEs) |
Time Frame: | Up to 21 months |
Safety Issue: | |
Description: | Part 2 |
Measure: | Incidence of Serious Adverse Events (SAEs) |
Time Frame: | Up to 21 months |
Safety Issue: | |
Description: | Part 2 |
Measure: | Incidence of select Adverse Events (AEs) |
Time Frame: | Up to 21 months |
Safety Issue: | |
Description: | Part 2 |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Bristol-Myers Squibb |
Trial Keywords
- Stage IV Non-small Cell Lunch Cancer
- Recurrent Non-small Cell Lung Cancer
- Metastatic Non-small Cell Lung Cancer
- Relatlimab
- Nivolumab
- Chemotherapy
Last Updated
August 25, 2021