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A Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
A Phase 1/2 Study of BMS-986340 as Monotherapy and as Combination Therapy in Participants With Advanced Solid Tumors
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable. * 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, (except for Part 1C, 2C and 2D, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated. * Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant. Exclusion Criteria * Women who are pregnant or breastfeeding. * 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. * Major surgery within 4 weeks of study drug administration. * History of or with active interstitial lung disease or pulmonary fibrosis. * Other protocol-defined inclusion/exclusion criteria apply.
About the study
The purpose of this study is to assess the safety, tolerability, and recommended dose(s) of BMS-986340 as monotherapy and in combination with nivolumab, docetaxel, or Pumitamig in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
What is being tested
- BMS-986340 (drug)
- BMS-936558-01 (drug)
- Docetaxel (drug)
- Pumitamig (drug)
Sponsor: Bristol-Myers Squibb · Participants: 1,109 · Started: May 27, 2021
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT04895709
Locations in the U.S.
Conditions
- Cervical Cancer
- Non-Small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
- Kidney Cancer (Renal Cell Carcinoma)
- Urothelial (Transitional Cell) Carcinoma
- Melanoma
- Ovarian Cancer
- Triple-Negative Breast Cancer
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.