A Phase 1/2 Study of BMS-986340 with and without Nivolumab or Docetaxel in Solid Tumors

Phase 1

Recruiting

• Conditions: Male and female participants = 18 years of age with advanced ormetastatic cancers; MedDRA version: 21.0Level: LLTClassification code: 10048683Term: Advanced cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-503651-10-00
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 277

Inclusion Criteria

Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis, Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy, Eastern Cooperative Oncology Group Performance Status of 0 or 1, Radiographically documented progressive disease on or after the most recent therapy, Received standard-of-care therapies, including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), Participants must have advanced or metastatic disease, and have received, be refractory to, not be a candidate for, or be intolerant to existing therapies known to provide clinical benefit for the condition of the participant. Eligible tumor types for each Part are listed below: - Parts 1A and 1B: NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, cervical cancer (SCC or adenocarcinoma), RCC, UC, PDAC, melanoma, OC, or TNBC. - Parts 2A and 2B: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, or up to 3 additional tumor types from Parts 1A and 1B may be considered based on emerging data. - Part 1C: NSCLC, SCCHN, gastric/GEJ adenocarcinoma, OC, or TNBC. Other protocol-defined inclusion criteria apply.

Exclusion Criteria

Women who are pregnant or breastfeeding, Major surgery within 4 weeks of study drug administration, History of or with active interstitial lung disease or pulmonary fibrosis Other protocol-defined exclusion criteria apply, Primary central nervous system (CNS) malignancy, Untreated CNS metastases, Leptomeningeal metastases, Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment, Active, known, or suspected autoimmune disease, Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment, Prior organ or tissue allograft, Uncontrolled or significant cardiovascular disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified