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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04623775
Recruitment Status : Recruiting
First Posted : November 10, 2020
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE November 5, 2020
First Posted Date  ICMJE November 10, 2020
Last Update Posted Date May 24, 2023
Actual Study Start Date  ICMJE February 17, 2021
Estimated Primary Completion Date May 28, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2022)
  • 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 ]
    Part 1
  • Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR) [ Time Frame: 10 months after randomization, up to 21 months ]
    Part 2
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • 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 ]
    Part 1
  • Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by blinded independent clinical review (BICR) [ Time Frame: 10 months after randomization, up to 21 months ]
    Part 2
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2022)
  • Incidence of TRAEs leading to discontinuation [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • Incidence of select Adverse Events (AEs) [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • PFS per RECIST v1.1 by BICR [ Time Frame: Up to approximately 3 years ]
    Part 2
  • Overall response rate (ORR) per RECIST v1.1 by BICR [ Time Frame: Up to approximately 2 years ]
    Part 2
  • Duration of Response (DoR) per RECIST v1.1 by BICR [ Time Frame: At 6 months, 12 months, and 18 months ]
    Part 2
  • Incidence of Adverse Events (AEs) [ Time Frame: Up to 21 months ]
    Part 2
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 21 months ]
    Part 2
  • Incidence of Treatment Related Adverse Events (TRAEs) [ Time Frame: Up to 21 months ]
    Part 2
  • Incidence of Immune-mediated Adverse Events (IMAEs) [ Time Frame: Up to 21 months ]
    Part 2
  • Incidence of select Adverse Events (AEs) [ Time Frame: Up to 21 months ]
    Part 2
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2020)
  • Incidence of TRAEs leading to discontinuation [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • Incidence of select Adverse Events (AEs) [ Time Frame: Up to 10 months, 30 days from participant's last dose ]
    Part 1
  • PFS per RECIST v1.1 by BICR in biomarker subgroups [ Time Frame: Until progression, up to 21 months ]
    Part 2
  • Overall response rate (ORR) per RECIST v1.1 by BICR [ Time Frame: Up to 21 months ]
    Part 2
  • Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 21 months ]
    Part 2
  • Incidence of select Adverse Events (AEs) [ Time Frame: Up to 21 months ]
    Part 2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • Recurrent Non-small Cell Lung Cancer
  • Metastatic Non-small Cell Lung Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
  • Biological: Relatlimab
    Specified dose on specified days
  • Drug: Carboplatin
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Drug: Cisplatin
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Drug: Paclitaxel
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Drug: Nab-Paclitaxel
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
  • Drug: Pemetrexed
    Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
Study Arms  ICMJE
  • Experimental: Part 1: Arm A (Nivolumab + Relatlimab Dose 1 + Platinum Doublet Chemotherapy (PDCT))
    Interventions:
    • Biological: Nivolumab
    • Biological: Relatlimab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Drug: Nab-Paclitaxel
    • Drug: Pemetrexed
  • Experimental: Part 1: Arm B (Nivolumab + Relatlimab Dose 2 + PDCT))
    Interventions:
    • Biological: Nivolumab
    • Biological: Relatlimab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Drug: Nab-Paclitaxel
    • Drug: Pemetrexed
  • Experimental: Part 2: Arm C (Nivolumab + Relatlimab Dose 2 + PDCT)
    Interventions:
    • Biological: Nivolumab
    • Biological: Relatlimab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Drug: Pemetrexed
  • Active Comparator: Part 2: Arm D (Nivolumab + PDCT)
    Interventions:
    • Biological: Nivolumab
    • Drug: Carboplatin
    • Drug: Cisplatin
    • Drug: Paclitaxel
    • Drug: Pemetrexed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2022)		 420
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2020)		 520
Estimated Study Completion Date  ICMJE September 16, 2025
Estimated Primary Completion Date May 28, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   France,   Germany,   Ireland,   Italy,   Mexico,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   Spain,   Switzerland,   Turkey,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04623775
Other Study ID Numbers  ICMJE CA224-104
2020-004026-31 ( EudraCT Number )
U1111-1256-8115 ( Registry Identifier: WHO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Bristol-Myers Squibb
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Bristol-Myers Squibb
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date May 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP