A Phase 1b/2 Study of BMS-986442 with Nivolumab with or without Chemotherapy in Solid Tumors and Non-small Cell Lung Cancer

Phase 1

Recruiting

Conditions: Solid Tumor, Non-small cell lung cancer
MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2022-503108-26-00

Lead Sponsor: Bristol-Myers Squibb Services Unlimited Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 245

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To characterize the safety and tolerability, and to establish the MTD, MAD, and/or RP2D of BMS-986442 in combination with nivolumab or with nivolumab and chemotherapy;Secondary Objective: To characterize the pharmacokinetics and immunogenicity, as well as assess the preliminary anti-tumor activity of BMS-combination with nivolumab or in combination with nivolumab and chemotherapy986442 administered in combination with nivolumab or in combination with nivolumab and chemotherapy;Primary end point(s): Incidence of AEs, SAEs, AEs meeting protocol defined DLT criteria, AEs leading to discontinuation, and death (per CTCAE v5.0).

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Summary measures of BMS-986442 PK parameters (such as, but not limited to, Cmax, Tmax, and AUC);Secondary end point(s):Incidence of ADAs, and anti tumor efficacy parameters (ORR, DOR, DCR, and PFSR at 6 months and 12 months per RECIST v1.1 by Investigator)