Clinical Trials/NCT04623775

NCT04623775

Active, not recruiting

Phase 2

A Phase 2 Randomized 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)

Bristol-Myers Squibb125 sites in 5 countries468 target enrollmentFebruary 17, 2021

ConditionsNon-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer

InterventionsNivolumab Relatlimab Carboplatin Cisplatin Paclitaxel Nab-Paclitaxel Pemetrexed

DrugsNivolumab Relatlimab Carboplatin Cisplatin Paclitaxel Nab-Paclitaxel Pemetrexed

Overview

Phase: Phase 2
Intervention: Nivolumab
Conditions: Non-small Cell Lung Cancer
Sponsor: Bristol-Myers Squibb
Enrollment: 468
Locations: 125
Primary Endpoint: TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1
Status: Active, not recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials Related News

Overview

Brief Summary

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).

Registry

clinicaltrials.gov

Start Date

February 17, 2021

End Date

February 27, 2026

Last Updated

6 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Intervention: Nivolumab

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Intervention: Relatlimab

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Intervention: Carboplatin

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Intervention: Cisplatin

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Intervention: Paclitaxel

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Intervention: Nab-Paclitaxel

Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))

Intervention: Pemetrexed

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Intervention: Nivolumab

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Intervention: Relatlimab

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Intervention: Carboplatin

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Intervention: Cisplatin

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Intervention: Paclitaxel

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Intervention: Nab-Paclitaxel

Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))

Intervention: Pemetrexed

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Intervention: Nivolumab

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Intervention: Relatlimab

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Intervention: Carboplatin

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Intervention: Cisplatin

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Intervention: Paclitaxel

Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)

Intervention: Pemetrexed

Part 2: Arm D (Nivolumab + PDCT)

Intervention: Nivolumab

Part 2: Arm D (Nivolumab + PDCT)

Intervention: Carboplatin

Part 2: Arm D (Nivolumab + PDCT)

Intervention: Cisplatin

Part 2: Arm D (Nivolumab + PDCT)

Intervention: Paclitaxel

Part 2: Arm D (Nivolumab + PDCT)

Intervention: Pemetrexed

Outcomes

Primary Outcomes

TRAEs Leading to Discontinuation Within 12 Weeks of First Dose in Part 1

Time Frame: from first dose to 12 weeks after first dose

Percentage of participants with treatment related adverse events (TRAEs) leading to discontinuation within 12 weeks of first dose. AE is defined as any new untoward medical occurrence or worsenig of a preexising medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. Grading will be determined for severity according to the NCI CTCAE v5.0.

ORR Per RECISTS v1.1 by BICR in Part 2

Time Frame: Approximately 14.8 Months

Objective Response Rate (ORR) per RECIST v1.1 by BICR is defined as the number of participants in the randomized population who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on BICR assessments (using RECIST v1.1) divided by the number of participants in the population. BOR is defined as the best response, as determined by the BICR, recorded between the date of randomization and the date of first objectively documented progression per RECIST v1.1 or the date of subsequent therapy, whichever occurs first.

Secondary Outcomes

TRAEs Leading to Discontinuation in Part 1(From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months))
Number of Participants With a Treatment Related AEs in Part 1(From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months))
Number of Participants With Treatment Releted SAEs in Part 1(From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months))
Number of Participants With Treatment Releted Select AEs in Part 1(From first dose to 30 days post last dose of study therapy (Approximately 32.8 Months))
ORR by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2(Approximately 14.8 Months)
DoR Per RECISTS v1.1 by BICR in Part 2(Approximately up to 13.7 months)
Number of Participants With a AE in Part 2(From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months))
Number of Participants With a Treatment Related AEs in Part 2(From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months))
PFS Per RECISTS v1.1 by BICR in Part 2(Ongoing)
PFS by PD-L1 Expression Per RECISTS v1.1 by BICR in Part 2(Ongoing)
PFS by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2(Ongoing)
PFS by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2(Ongoing)
Number of Participants With Treatment Releted Select AEs in Part 2(Ongoing)
Number of Participants With a Treatment Related SAEs in Part 2(From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months))
Number of Participants With Endocrine Immune-mediated Adverse Events in Part 2(From first dose to 30 days post last dose of study therapy (Approximately 14.8 Months))
ORR by LAG-3 Expression Per RECISTS v1.1 by BICR in Part 2(On Going)
ORR by FG-L1 Expression Per RECISTS v1.1 by BICR in Part 2(Ongoing)