Actively Recruiting
A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-06-08
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of BMS-986504 combined with chemotherapy and surgery to control pancreatic cancer in patients with a specific genetic deletion called MTAP. This Phase II trial focuses on safety, tolerability, and effectiveness of these treatments in three groups: those with resectable or borderline resectable pancreatic cancer, locally advanced cancer, and metastatic cancer. The study aims to understand how well the treatment works and the complications around surgery and cancer control at 6 months. Participants in Cohort 1 receive BMS-986504 with gemcitabine and nab-paclitaxel chemotherapy for four cycles before and after surgery, followed by maintenance therapy. Cohorts 2 and 3 receive BMS-986504 with standard chemotherapy regimens: gemcitabine and nab-paclitaxel for Cohort 2, and mFOLFIRINOX for Cohort 3, each followed by maintenance treatment as long as the disease does not worsen. Treatments are given by mouth or intravenous infusion depending on the drug. During the study, participants will have regular visits for safety and side effect monitoring, including blood tests and imaging to assess disease control. Researchers will measure treatment safety and adverse events over about one year and evaluate response rates and disease control at six months. Participants must agree to follow the treatment and visit schedules, and the study will last until October 2031.
CONDITIONS
Brief Title
A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Homozygous MTAP deletion detected by NGS on recent or archival tissue or blood samples
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC)
- Adequate organ and marrow function as defined by blood counts and liver and kidney tests
- Allowed prior treatment: 1 month of gemcitabine and nab-paclitaxel (Cohorts 1 and 2) or mFOLFIRINOX (Cohort 3)
- Willingness to follow study protocol including treatments and visits
- Ability to understand and sign informed consent
- Women of child-bearing potential must use highly effective contraception during and after treatment
- Male participants must use condoms during and for months after treatment and agree to refrain from sperm donation
You will not qualify if you...
- Prior treatment with PRMT5 and MAT2A inhibitors
- Recent exposure to investigational agents within 30 days or 5 half-lives
- Other primary cancers unless treated and disease-free for 2 or more years
- Major surgery within 2 weeks before treatment start
- Significant fluid retention requiring drainage within 1 month prior to randomization
- Certain heart conditions including low ejection fraction and prolonged QT interval
- Uncontrolled or significant cardiovascular diseases within 6 months prior to enrollment
- Use of medications that strongly affect CYP3A4/P-glycoprotein or proton-pump inhibitors that cannot be changed
- Active viral hepatitis B or C infections
- Certain HIV conditions unless stable on therapy
- Active infections requiring systemic treatment within 7 days before treatment
- Live vaccine within 30 days before treatment
- Use of botanical preparations for the disease within 4 weeks prior to treatment
- Prior organ transplant
- Allergy to study drugs or components
- Known central nervous system metastases unless treated and stable
- Inability to swallow oral medication or gastrointestinal issues affecting absorption
- Pregnant or breastfeeding women
- History of certain lung diseases or multiple allergies
- Cohort-specific exclusions including metastatic disease or prior treatments as detailed in protocol
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 - 4 to 6 months or until disease progression or discontinuation
Participants receive BMS-986504 in combination with chemotherapy regimens depending on their cohort. Cohort 1 receives BMS-986504, gemcitabine, and nab-paclitaxel for 4 treatment cycles. Cohort 2 receives BMS-986504, gemcitabine, and nab-paclitaxel for 4-6 months followed by maintenance therapy with BMS-986504 alone. Cohort 3 receives BMS-986504 and mFOLFIRINOX for 4-6 months.
Regular visits for treatment and monitoring during therapy
Duration - Up to 1 year or until study completion
Participants are monitored for safety, tolerability, and disease control after treatment completion, including assessment of adverse events and efficacy outcomes.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Maria P Morelli, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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