A Study of BMS-986442 With Nivolumab With or Without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05543629

Collaborator

(none)

225

Enrollment

Location

Arms

49.1

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate BMS-986442 in combination with nivolumab (with or without chemotherapy) for its antitumor efficacy and benefit to participants.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumors Non-small Cell Lung Cancer	Biological: BMS-986442 Biological: Nivolumab Drug: Docetaxel Drug: Carboplatin Drug: Pemexetred Drug: Paclitaxel	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

225 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1b/2 Study of BMS-986442 in Combination With Nivolumab or Nivolumab and Chemotherapies in Participants With Advanced Solid Tumors and Non-small Cell Lung Cancer

Anticipated Study Start Date :

Sep 28, 2022

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

Nov 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: BMS-986442 + Nivolumab	Biological: BMS-986442 Specified dose on specified days Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558
Experimental: Part B1: BMS-986442 + Nivolumab Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)	Biological: BMS-986442 Specified dose on specified days Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558
Experimental: Part B2: BMS-986442 + Nivolumab Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)	Biological: BMS-986442 Specified dose on specified days Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558
Experimental: Part C: BMS-986442 + Nivolumab + Docetaxel	Biological: BMS-986442 Specified dose on specified days Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Drug: Docetaxel Specified dose on specified days Other Names: Taxane / Toxotere chemotherapy
Experimental: Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed	Biological: BMS-986442 Specified dose on specified days Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Drug: Carboplatin Specified dose on specified days Other Names: Platinum chemotherapy Drug: Pemexetred Specified dose on specified days Other Names: Folate analog metabolic inhibitor
Experimental: Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel	Biological: BMS-986442 Specified dose on specified days Biological: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558 Drug: Carboplatin Specified dose on specified days Other Names: Platinum chemotherapy Drug: Paclitaxel Specified dose on specified days Other Names: Taxane chemotherapy

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events (AEs) [Up to 119 Weeks]
Incidence of Serious Adverse Events (SAEs) [Up to 119 Weeks]
Incidence of AEs meeting protocol-defined Dose Limiting Toxicity (DLT) criteria [Up to 119 Weeks]
Incidence of AEs leading to discontinuation [Up to 119 Weeks]
Incidence of AEs leading to death [Up to 119 Weeks]

Secondary Outcome Measures

Maximum observed plasma concentration (Cmax) [Up to 119 Weeks]
Time of maximum observed concentration (Tmax) [Up to 119 Weeks]
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) [Up to 119 Weeks]
Incidence of Anti-drug Antibodies (ADAs) to BMS-986442 [Up to 119 Weeks]
Objective Response Rate (ORR) [At 6 months and 12 months]
Duration of Response (DOR) [At 6 months and 12 months]
Disease Control Rate (DCR) [At 6 months and 12 months]
Progression-free Survival Rate (PFSR) [At 6 months and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants in all parts of the study must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Participants must have a life expectancy of at least 3 months at the time of first dose.

Exclusion Criteria:

Untreated symptomatic central nervous system metastases or leptomeningeal metastases.
Concurrent malignancy (present during screening) requiring treatment, or history of prior malignancy active within 2 years prior to randomization in study Part B1 or treatment assignment in all other study parts.
Participants with an active, known, or suspected autoimmune disease.

Other protocol-defined inclusion/exclusion criteria apply.