Actively Recruiting
A Phase 1/1b Open-label Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Led by Bristol-Myers Squibb · Updated on 2026-06-03
437
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and anti-cancer activity of an experimental drug called BMS-986488, given alone or in combination with other treatments, in adults with advanced malignant tumors. This phase 1/1b open-label study focuses on patients with specific types of advanced or metastatic solid tumors, including clear-cell renal cell carcinoma, clear-cell ovarian cancer, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma, among others. The study aims to understand how BMS-986488 works alone and combined with other drugs in these cancers. Participants receive BMS-986488 as a monotherapy or combined with other drugs like Adagrasib, Cetuximab, or Nivolumab. The treatments are given in several study parts, with specified doses on certain days. The study includes parts where BMS-986488 is given alone or with one or two other drugs depending on tumor type and genetic mutations. This non-randomized study is open-label, meaning both doctors and participants know which treatments are given. During the study, participants are closely monitored for side effects and treatment responses using standard measures, such as adverse events, serious adverse events, and dose-limiting toxicities over a safety follow-up period of about 100 days after the last dose. Researchers also measure treatment effects on tumor size and disease control up to 52 weeks after treatment ends. Blood tests track drug levels in the body. The study starts with screening and continues through treatment and safety monitoring, lasting until the end of follow-up in 2027.
CONDITIONS
Brief Title
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older.
- Histologically confirmed diagnosis of a locally advanced and unresectable or metastatic solid tumor malignancy.
- Specific tumor types include clear-cell renal cell carcinoma, clear-cell ovarian cancer, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.
- Tumors with KRAS G12C mutation for certain study parts.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Measurable disease according to RECIST v1.1 criteria.
You will not qualify if you...
- Untreated central nervous system metastases.
- Leptomeningeal metastasis (carcinomatous meningitis).
- Impaired cardiac function or clinically significant cardiac disease.
- For combination with adagrasib: history of pneumonitis or interstitial lung disease.
- History of severe cutaneous adverse reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Other protocol-defined inclusion and exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive BMS-986488 either alone or in combination with Adagrasib, Cetuximab, or Nivolumab according to their assigned study part.
Visits occur on specified dosing days during each 28-day cycle
Duration - Up to approximately 100 days after last dose
Participants are monitored for safety and adverse events after the last dose of study treatment.
Approximately 3 to 4 visits during follow-up
Duration - Up to 52 weeks after end of treatment visit
Participants are followed for survival and disease outcomes up to 52 weeks after the end of treatment.
Visits scheduled periodically during this long-term follow-up period
Trial Site Locations
Total: 8 locations
1
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
2
Local Institution - 0020
Allentown, Pennsylvania, United States, 18103
Active, Not Recruiting
3
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States, 38138
Actively Recruiting
4
Local Institution - 0025
Dallas, Texas, United States, 75390
Withdrawn
5
Local Institution - 0031
Brisbane, Queensland, Australia, 4029
Active, Not Recruiting
6
Local Institution - 0032
Vancouver, British Columbia, Canada, V5Z 4E6
Active, Not Recruiting
7
Local Institution - 0015
Montreal, Quebec, Canada, H2X 0A9
Not Yet Recruiting
8
Local Institution - 0016
Québec, Quebec, Canada, G1J 1Z4
Active, Not Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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