Back to resultsA 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)
Primary Purpose
NSCLC
Status
Not yet recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986315
Nivolumab
Pemetrexed
Cisplatin
Carboplatin
Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for NSCLC focused on measuring Pharmacokinetics, BMS-986315, Nivolumab, Platinum doublet chemotherapy, NSCLC, Lung cancer
Eligibility Criteria
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.
Sites / Locations
- Saint Alphonsus Regional Medical Center
- MAYO
- The Medical University of South Carolina
- Swedish Cancer Institute
- Local Institution - 0022
- Local Institution - 0043
- Local Institution - 0006
- Local Institution - 0015
- Local Institution - 0066
- Local Institution - 0062
- Local Institution - 0060
- Local Institution - 0061
- Local Institution - 0065
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Active Comparator
Experimental
Experimental
Arm Label
Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT
Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
Part 2: Nivolumab + Histology-based PDCT
Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT
Arm Description
Outcomes
Primary Outcome Measures
Part 1: Number of Participants with Adverse Events (AEs)
Part 1: Number of Participants with Treatment-related AEs (TRAEs)
Part 1: Number of Participants with Serious AEs (SAEs)
Part 1: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria
Part 1: Number of Participants with AEs Leading to Discontinuation
Part 1: Number of Participants with AEs Leading to Death
Part 2: Objective Response Rate (ORR)
Secondary Outcome Measures
Part 2: Progression Free Survival (PFS)
Part 2: Number of Participants with AEs
Part 2: Number of Participants with TRAEs
Part 2: Number of Participants with SAEs
Part 2: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria
Part 2: Duration of Response (DOR)
Part 2: Time to Response (TTR)
Part 2: Disease Control Rate (DCR)
Part 2: Maximum Observed Serum Concentration (Cmax)
Part 2: Time of Cmax (Tmax)
Part 2: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
Part 2: Number of Participants with Anti-drug Antibodies to BMS-986315
Full Information
NCT ID
NCT06094296
First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT06094296
Brief Title
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)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 3, 2023 (Anticipated)
Primary Completion Date
October 10, 2026 (Anticipated)
Study Completion Date
October 10, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NSCLC
Keywords
Pharmacokinetics, BMS-986315, Nivolumab, Platinum doublet chemotherapy, NSCLC, Lung cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
196 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT
Arm Type
Experimental
Arm Title
Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
Arm Type
Experimental
Arm Title
Part 2: Nivolumab + Histology-based PDCT
Arm Type
Active Comparator
Arm Title
Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
Arm Type
Experimental
Arm Title
Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BMS-986315
Other Intervention Name(s)
Anti-NKG2A
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo, BMS-936558
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Pemetrexed
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Part 1: Number of Participants with Adverse Events (AEs)
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 1: Number of Participants with Treatment-related AEs (TRAEs)
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 1: Number of Participants with Serious AEs (SAEs)
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 1: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 1: Number of Participants with AEs Leading to Discontinuation
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 1: Number of Participants with AEs Leading to Death
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 2: Objective Response Rate (ORR)
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Part 2: Progression Free Survival (PFS)
Time Frame
Up to 5 years
Title
Part 2: Number of Participants with AEs
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 2: Number of Participants with TRAEs
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 2: Number of Participants with SAEs
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 2: Number of Participants with AEs Meeting Protocol-defined Dose Limiting Toxicity DLT Criteria
Time Frame
Up to 100 days after discontinuation of study treatment
Title
Part 2: Duration of Response (DOR)
Time Frame
Up to 5 years
Title
Part 2: Time to Response (TTR)
Time Frame
Up to 5 years
Title
Part 2: Disease Control Rate (DCR)
Time Frame
Up to 5 years
Title
Part 2: Maximum Observed Serum Concentration (Cmax)
Time Frame
Predose and postdose up to 2 years
Title
Part 2: Time of Cmax (Tmax)
Time Frame
Predose and postdose up to 2 years
Title
Part 2: Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration (AUC[0-T])
Time Frame
Predose and postdose up to 2 years
Title
Part 2: Number of Participants with Anti-drug Antibodies to BMS-986315
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain the NCT# and Site #.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bobby Chawla, Site 0058
Phone
208-367-3131
Facility Name
MAYO
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Konstantinos Leventakos, Site 0064
Phone
507-284-2511
Facility Name
The Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariam Alexander, Site 0059
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98275
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Paulson, Site 0063
Facility Name
Local Institution - 0022
City
Cordoba City
State/Province
Provincia De Cordoba
ZIP/Postal Code
X5004FHP
Country
Argentina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0043
City
Vina Del Mar
State/Province
Valparaiso
ZIP/Postal Code
252 0598
Country
Chile
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0043
Facility Name
Local Institution - 0006
City
Rome
ZIP/Postal Code
00128
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0006
Facility Name
Local Institution - 0015
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0066
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400132
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0066
Facility Name
Local Institution - 0062
City
Cluj-Napoca
ZIP/Postal Code
400015
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0062
Facility Name
Local Institution - 0060
City
Cluj-napoca
ZIP/Postal Code
400641
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0060
Facility Name
Local Institution - 0061
City
Craiova
ZIP/Postal Code
200347
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0061
Facility Name
Local Institution - 0065
City
Floresti
ZIP/Postal Code
407280
Country
Romania
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0065
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form
Learn more about this trial
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)
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