A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
About the study
Who can take part
INCLUSION 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, 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
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
Study Locations
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How to Apply
Study’s details
Contition
Cervical Cancer,Gastric/Gastroesophageal Junction Adenocarcinoma,Microsatellite Stable Colorectal Cancer,Non-Small-Cell Lung Cancer,Squamous Cell Carcinoma of Head and Neck,Carcinoma, Renal Cell,Urothelial Carcinoma,Pancreatic Adenocarcinoma,Melanoma,Ovarian Neoplasms,Triple Negative Breast Neoplasms
Age (in years)
18+
Phase
PHASE1/PHASE2
Participants needed
949
Est. Completion Date
Jul 7, 2028
Treatment type
INTERVENTIONAL
Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT04895709
Study number
CA052002
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