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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Advanced Solid Tumors
Non-small Cell Lung Cancer

Treatments

Drug: Carboplatin
Biological: BMS-986442
Drug: Pemexetred
Drug: Docetaxel
Drug: Paclitaxel
Biological: Nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05543629
U1111-1283-1243 (Registry Identifier)
2022-501676-26 (EudraCT Number)
CA115-001

Details and patient eligibility

About

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.

Enrollment

225 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

225 participants in 6 patient groups

Part A: BMS-986442 + Nivolumab
Experimental group
Treatment:
Biological: Nivolumab
Biological: BMS-986442
Part B1: BMS-986442 + Nivolumab
Experimental group
Description:
Second line (2L) + Post-immuno-oncology (IO)/Platinum-Doublet Non-small cell lung cancer (NSCLC)
Treatment:
Biological: Nivolumab
Biological: BMS-986442
Part B2: BMS-986442 + Nivolumab
Experimental group
Description:
Post IO Gastric Cancer/Gastroesophageal Junction and Post-IO squamous cell carcinoma of the head and neck (SCCHN)
Treatment:
Biological: Nivolumab
Biological: BMS-986442
Part C: BMS-986442 + Nivolumab + Docetaxel
Experimental group
Treatment:
Biological: Nivolumab
Drug: Docetaxel
Biological: BMS-986442
Part D: BMS-986442 + Nivolumab + Carboplatin + Pemetrexed
Experimental group
Treatment:
Biological: Nivolumab
Drug: Pemexetred
Biological: BMS-986442
Drug: Carboplatin
Part E: BMS-986442 + Nivolumab + Carboplatin + Paclitaxel
Experimental group
Treatment:
Drug: Paclitaxel
Biological: Nivolumab
Biological: BMS-986442
Drug: Carboplatin

Trial contacts and locations

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Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Study Connect Contact Center www.BMSStudyConnect.com

Data sourced from clinicaltrials.gov

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