Clincosm LogoSign in Get a demo

A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06094296
Collaborator
(none)
196
Enrollment
13
Locations
5
Arms
47.2
Anticipated Duration (Months)
15.1
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) versus nivolumab in combination with PDCT in the first-line treatment of Stage IV or recurrent non-small cell lung cancer (NSCLC).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
196 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Phase 2 Study of BMS-986315 and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)
Anticipated Study Start Date :
Nov 3, 2023
Anticipated Primary Completion Date :
Oct 10, 2026
Anticipated Study Completion Date :
Oct 10, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT

Drug: BMS-986315
Specified dose on specified days
Other Names:
  • Anti-NKG2A

    • Drug: Pemetrexed
    Specified dose on specified days

    Drug: Cisplatin
    Specified dose on specified days

    Drug: Carboplatin
    Specified dose on specified days

    Drug: Paclitaxel
    Specified dose on specified days
    Experimental: Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

    Drug: BMS-986315
    Specified dose on specified days
    Other Names:
  • Anti-NKG2A

    • Drug: Pemetrexed
    Specified dose on specified days

    Drug: Cisplatin
    Specified dose on specified days

    Drug: Carboplatin
    Specified dose on specified days

    Drug: Paclitaxel
    Specified dose on specified days
    Active Comparator: Part 2: Nivolumab + Histology-based PDCT

    Drug: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    • Drug: Pemetrexed
    Specified dose on specified days

    Drug: Cisplatin
    Specified dose on specified days

    Drug: Carboplatin
    Specified dose on specified days

    Drug: Paclitaxel
    Specified dose on specified days
    Experimental: Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

    Drug: BMS-986315
    Specified dose on specified days
    Other Names:
  • Anti-NKG2A

    • Drug: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    • Drug: Pemetrexed
    Specified dose on specified days

    Drug: Cisplatin
    Specified dose on specified days

    Drug: Carboplatin
    Specified dose on specified days

    Drug: Paclitaxel
    Specified dose on specified days
    Experimental: Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

    Drug: BMS-986315
    Specified dose on specified days
    Other Names:
  • Anti-NKG2A

    • Drug: Nivolumab
    Specified dose on specified days
    Other Names:
  • Opdivo
  • BMS-936558

    • Drug: Pemetrexed
    Specified dose on specified days

    Drug: Cisplatin
    Specified dose on specified days

    Drug: Carboplatin
    Specified dose on specified days

    Drug: Paclitaxel
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Part 1: Number of Participants with Adverse Events (AEs) [Up to 100 days after discontinuation of study treatment]

    2. Part 1: Number of Participants with Treatment-related AEs (TRAEs) [Up to 100 days after discontinuation of study treatment]

    3. Part 1: Number of Participants with Serious AEs (SAEs) [Up to 100 days after discontinuation of study treatment]

    4. Part 1: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria [Up to 100 days after discontinuation of study treatment]

    5. Part 1: Number of Participants with AEs Leading to Discontinuation [Up to 100 days after discontinuation of study treatment]

    6. Part 1: Number of Participants with AEs Leading to Death [Up to 100 days after discontinuation of study treatment]

    7. Part 2: Objective Response Rate (ORR) [Up to 5 years]

    Secondary Outcome Measures

    1. Part 2: Progression Free Survival (PFS) [Up to 5 years]

    2. Part 2: Number of Participants with AEs [Up to 100 days after discontinuation of study treatment]

    3. Part 2: Number of Participants with TRAEs [Up to 100 days after discontinuation of study treatment]

    4. Part 2: Number of Participants with SAEs [Up to 100 days after discontinuation of study treatment]

    5. Part 2: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria [Up to 100 days after discontinuation of study treatment]

    6. Part 2: Duration of Response (DOR) [Up to 5 years]

    7. Part 2: Time to Response (TTR) [Up to 5 years]

    8. Part 2: Disease Control Rate (DCR) [Up to 5 years]

    9. Part 2: Maximum Observed Serum Concentration (Cmax) [Predose and postdose up to 2 years]

    10. Part 2: Time of Cmax (Tmax) [Predose and postdose up to 2 years]

    11. Part 2: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T]) [Predose and postdose up to 2 years]

    12. Part 2: Number of Participants with Anti-drug Antibodies to BMS-986315 [Up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Participants must have NSCLC with Stage IV or recurrent disease following multimodal therapy for locally advanced disease.

    • Study treatment must be first-line therapy for Stage IV or recurrent disease.

    • Participants in all parts of the study must have:

    • measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1. (RECIST v1.1)

    • an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

    • a life expectancy of at least 3 months at the time of first dose

    Exclusion Criteria:

    • Untreated symptomatic central nervous system metastases

    • Participants with epidermal growth factor receptor (EGFR)/ALK receptor tyrosine kinase (ALK)/ROS proto-oncogene 1 (ROS1)/neurotrophic tyrosine receptor kinase (NTRK)/MET proto-oncogene (MET)/B-Raf proto-oncogene (BRAF)/RET proto-oncogene (RET) mutations amenable to targeted therapies

    • Participants with any known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results

    Note: Other protocol-defined inclusion/exclusion criteria apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saint Alphonsus Regional Medical Center Boise Idaho United States 83706
    2 MAYO Rochester Minnesota United States 55905
    3 The Medical University of South Carolina Charleston South Carolina United States 29425
    4 Swedish Cancer Institute Seattle Washington United States 98275
    5 Local Institution - 0022 Cordoba City Provincia De Cordoba Argentina X5004FHP
    6 Local Institution - 0043 Vina Del Mar Valparaiso Chile 252 0598
    7 Local Institution - 0006 Rome Italy 00128
    8 Local Institution - 0015 Gdansk Pomorskie Poland 80-952
    9 Local Institution - 0066 Cluj-Napoca Cluj Romania 400132
    10 Local Institution - 0062 Cluj-Napoca Romania 400015
    11 Local Institution - 0060 Cluj-napoca Romania 400641
    12 Local Institution - 0061 Craiova Romania 200347
    13 Local Institution - 0065 Floresti Romania 407280

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT06094296
    Other Study ID Numbers:
    • CA047-1009
    • 2022-503007-22
    • U1111-1282-5699
    First Posted:
    Oct 23, 2023
    Last Update Posted:
    Oct 23, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Pharmacokinetics
    BMS-986315
    Nivolumab
    Platinum doublet chemotherapy
    NSCLC
    Lung cancer
    Additional relevant MeSH terms:
    Lung Neoplasms
    Paclitaxel
    Carboplatin
    Nivolumab
    Pemetrexed

    Study Results

    No Results Posted as of Oct 23, 2023