A Study of BMS-986406 as Monotherapy and Combination Therapies in Participants With Advanced Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Cancer

Treatments: Biological: Nivolumab; Drug: Pemetrexed; Biological: BMS-986406; Drug: Carboplatin; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05298592

U1111-1270-3670 (Registry Identifier)

CA111-001

2021-006872-17 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of BMS-986406 administered alone, in combination with nivolumab, or in combination with nivolumab and platinum-doublet chemotherapy (PDCT) in participants with advanced tumors.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Parts 1A, 1B, 1C:

• Histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent malignant tumor. Eligible tumor types are non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction, castration-resistant prostate cancer (CRPC), ovarian, squamous cell carcinoma of the head and neck (SCCHN), bladder, melanoma, mesothelioma, triple negative breast cancer (TNBC), and soft tissue sarcoma, except for participants with tumors with central nervous system (CNS) metastases as the only site of active disease

Part 1D:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) of non-squamous or squamous histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease, who have not had systemic therapy for metastatic or recurrent disease.

All Parts:

• Measurable disease by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), Prostate Cancer Working Group 3 (PCWG3) (for prostate cancer), or modified Response Evaluation Criteria in Solid tumors (mRECIST) (for mesothelioma)
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Adequate organ function

Exclusion criteria

• Prior organ or tissue allograft
• Leptomeningeal metastases
• Untreated CNS metastases
• Serious or uncontrolled medical disorders

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 5 patient groups

Part 1A: BMS-986406 (Monotherapy Dose Escalation)

Experimental group

Treatment:

Biological: BMS-986406

Part 1B: BMS-986406 + Nivolumab (Combination Dose Escalation)

Experimental group

Treatment:

Biological: BMS-986406

Biological: Nivolumab

Part 1C: BMS-986406 + Nivolumab (Indication-Specific Dose Expansion)

Experimental group

Treatment:

Biological: BMS-986406

Biological: Nivolumab

Part 2: BMS-986406 + Nivolumab (Expansion Cohorts)

Experimental group

Treatment:

Biological: BMS-986406

Biological: Nivolumab

Part 1D: BMS-986406 + Nivolumab + Carboplatin with Pemetrexed or Paclitaxel

Experimental group

Treatment:

Drug: Paclitaxel

Drug: Carboplatin

Drug: Pemetrexed

Biological: BMS-986406

Biological: Nivolumab