Actively Recruiting
A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-04-16
60
Participants Needed
1
Research Sites
280 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
To find out if the combination of BMS-986504 plus neoadjuvant/adjuvant chemotherapy and surgery (Cohort 1) or BMS-986504 plus standard of care chemotherapy (Cohorts 2 and 3) can help to control pancreatic cancer.
CONDITIONS
Official 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 confirmed by next-generation sequencing within 6 months prior to enrollment
- ECOG performance status of 0 or 1
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma
- Adequate organ and marrow function as defined by specific blood and liver function thresholds
- Calculated creatinine clearance of at least 50 mL/min
- Allowed to have received 1 month of gemcitabine plus nab-paclitaxel (cohorts 1 and 2) or mFOLFIRINOX (cohort 3) without disease progression
- Ability and willingness to comply with study protocol and provide informed consent
- Women of child-bearing potential must use highly effective contraception methods during and for at least 9 months after treatment
- Male participants must use condoms during sexual activity with women of child-bearing potential during and for at least 6 months after treatment
- Cohort 1: Resectable or borderline resectable pancreatic adenocarcinoma with no prior neoadjuvant treatment
- Cohort 2: Locally advanced, unresectable pancreatic cancer without prior progression on up to one month of chemotherapy
- Cohort 3: Metastatic pancreatic adenocarcinoma without prior progression on up to one month of chemotherapy
You will not qualify if you...
- Prior treatment with PRMT5 or MAT2A inhibitors
- Use of investigational agents within 30 days or 5 half-lives before enrollment
- Presence of other primary cancers unless adequately treated and disease-free for at least 2 years
- Major surgery within 2 weeks before starting treatment
- Significant fluid retention requiring drainage within 1 month before randomization
- Cardiac abnormalities including reduced ejection fraction, prolonged QTc interval, or recent serious cardiovascular events
- Use of medications with high risk of drug interactions that cannot be changed before study entry
- Active viral hepatitis B or C infection or untreated HIV with recent opportunistic infection
- Active infection requiring systemic therapy within 7 days before first dose
- Live vaccines received within 30 days before treatment
- Use of botanical preparations intended to treat the disease within 4 weeks prior to treatment
- Prior organ transplant
- Allergy to study drugs or components
- Known untreated or unstable central nervous system metastases
- Inability to swallow oral medication or gastrointestinal conditions affecting absorption
- Pregnancy or breastfeeding
- History of interstitial lung disease or other serious lung conditions
- Cohort 1: Presence of metastatic or locally advanced disease or need for preoperative radiation
- Cohorts 2 and 3: Recent chemotherapy or targeted therapy within 28 days before treatment, multiple prior therapy lines, or significant persistent toxicities from previous cancer treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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