A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
Purpose
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 or docetaxel in participants with advanced solid tumors. This study is a first-in-human (FIH) study of BMS-986340 in participants with advanced solid tumors.
Conditions
- 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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- 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 Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
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Experimental Part 1A: BMS-986340 Dose Escalation |
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Experimental Part 2A: BMS-986340 Dose Expansion |
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Experimental Part 1B: BMS-986340 + Nivolumab Dose Escalation |
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Experimental Part 2B: BMS-986340 + Nivolumab Dose Expansion |
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Experimental Part 1C: BMS-986340 + Docetaxel Dose Escalation |
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Recruiting Locations
Vanderbilt University Medical Center
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Contact:
Jordan Berlin, Site 0052
615-343-4967
Jordan Berlin, Site 0052
615-343-4967
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Study Connect Contact Center www.BMSStudyConnect.com855-907-3286
Clinical.Trials@bms.com