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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)

NCT04623775

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).

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
NivolumabPart 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
RelatlimabPart 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
CarboplatinPart 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
CisplatinPart 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
PaclitaxelPart 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
Nab-PaclitaxelPart 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
PemetrexedPart 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

NameTypeDescriptionInterventions
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 enrollment (ie, participants with a history of prior malignancy are
             eligible if treatment was completed at least 2 years before registration 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 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 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:Not yet 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

November 10, 2020