A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Purpose
This purpose of this study is to determine if experimental treatment with BMS-986488, alone, or in combinations is safe, tolerable, and has anti-cancer activity in patients with advanced malignant tumors.
Condition
- Advanced Malignant Tumors
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participant must be ≥ 18 years of age. - Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy with any of the following tumor types:. - Part 1A: clear-cell renal cell carcinoma (ccRCC), clear-cell ovarian cancer (ccOC), non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC). - Parts 2A, 1D, 2D: ccRCC. i) Part 1B: solid tumors with KRAS G12C mutation. ii) Part 2B: NSCLC with KRAS G12C mutation. iii) Parts 1C, 2C: colorectal cancer (CRC) with KRAS G12C mutation. - Participants must have an Eastern Cooperative Oncology Groups (ECOG) Performance Status of 0 or 1. - Participants must have measurable disease per RECIST v1.1.
Exclusion Criteria
- Untreated central nervous system (CNS) metastases. - Leptomeningeal metastasis (carcinomatous meningitis). - Impaired cardiac function or clinically significant cardiac disease. - For Parts 1B, 1C, 2B, 2C only (combination with adagrasib):. i) History of pneumonitis or interstitial lung disease (ILD). ii) History of prior severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). - Other protocol-defined inclusion/exclusion criteria apply.
Study Design
- Phase
- Phase 1
- 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-986488 Monotherapy |
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Experimental Part 1B: BMS-986488 + Adagrasib |
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Experimental Part 1C: BMS-986488 + Adagrasib + Cetuximab |
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Experimental Part 1D: BMS-986488 + Nivolumab |
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Experimental Part 2A: BMS-986488 Monotherapy |
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Experimental Part 2B: BMS-986488 + Adagrasib |
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Experimental Part 2C: BMS-986488 + Adagrasib + Cetuximab |
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Experimental Part 2D: BMS-986488 + Nivolumab |
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Recruiting Locations
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
Contact:
Martin Gutierrez, Site 0021
551-996-5863
Martin Gutierrez, Site 0021
551-996-5863
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee 38138
Germantown, Tennessee 38138
Contact:
Daniel Vaena, Site 0024
901-598-1454
Daniel Vaena, Site 0024
901-598-1454
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com