Phase II Study of BMS-986504 for MTAP-deleted Pancreatic Cancer
This study is looking at BMS-986504 in people with pancreatic cancer that has a specific genetic change called an MTAP deletion. Researchers want to see if BMS-986504, when given with standard chemotherapy like Gemcitabine, Nab-paclitaxel, or mFOLFIRINOX, can help control the cancer. The study will also look at how safe BMS-986504 is and any side effects you might experience. To join, you must be at least 18 years old, have pancreatic cancer with an MTAP deletion confirmed by a genetic test, and be generally well enough to participate. The main goal is to understand the safety of BMS-986504 and how well it helps control the cancer, with safety being measured for about one year.
- Study design
- This is a Phase II interventional study planning to enroll 60 participants. It is designed to evaluate the safety and effectiveness of BMS-986504 in combination with standard treatments.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and adverse events will be measured through study completion, which is an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07283705
A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer
Recruiting
PHASE2Ages 18+InterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~60 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:BMS-986504GemcitabineNab-paclitaxelmFOLFIRINOX
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Maria P Morelli, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
Prior treatment with PRMT5 and MAT2A inhibitors.
Exposure to an investigational agent within 30 days or 5 half-lives (whichever is longer) prior to trial enrolment is not permitted.
Participants with other primary cancers are excluded, except for adequately treated nonmelanoma skin cancer, prostate cancer post-resection with undetectable PSA, in-situ cervical cancer, ductal carcinoma in situ (DCIS) of the breast, Stage 1 Grade 1 endometrial carcinoma, or solid tumors (including lymphomas without bone marrow involvement) curatively treated with no evidence of disease for ≥2 years prior to study entry.
Major surgery within 2 weeks of starting treatment is not permitted. Participants must have recovered from the effects of any major surgery.
Significant third-space fluid retention (e.g., ascites or peritoneal effusion) that requires drainage within 1 month prior to randomization.
Cardiac abnormalities including:
Left ventricular ejection fraction \< 50%
History of prolonged QTc, or QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation \> 480 msec, except for right bundle branch block
Uncontrolled/symptomatic or significant cardiovascular conditions within 6 months prior to enrollment, including but not limited to any of the following:
Cardiac angioplasty or stenting, myocardial infarction, stroke/transient ischemic attack, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, New York Heart Association (NYHA) class III-IV congestive heart failure, pericarditis, myocarditis, atrial fibrillation or other arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade's de pointes)
Ongoing need for a medication with a known risk of Torsade's de Pointes or known as a strong inhibitor or strong inducer of CYP3A4 and/or P-glycoprotein or a proton-pump inhibitor that cannot be switched to alternative treatment prior to study entry. The following drug interaction databases and other literature can be utilized to determine the CYP3A4/Pgp inhibitors and inducers:
https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-anddruginteractions- table-substrates-inhibitors-and-inducers.
https://druginteractions.medicine.iu.edu/MainTable.aspx. Note: Please consult with the Sponsor Medical Monitor for any uncertainties regarding potential CYP3A4 and P-gp modulators.
Active viral hepatitis, including the following:
Any positive test result for hepatitis B virus (HBV) indicating presence of virus, e.g., HBV DNA positive would be excluded. Participants with anti-HBs positive in line with prior vaccination or resolved infection are eligible to enroll.
Any positive test result for hepatitis C virus (HCV) indicating presence of active viral replication (detectable HCV RNA).
Participants with positive HCV antibody and an undetectable HCV RNA are eligible to enroll.
Known human immunodeficiency virus (HIV) positive with an AIDS-defining opportunistic infection within the last year, or a current CD4 count \< 350 cells/μL. Participants with HIV are eligible if they have received established antiretroviral therapy (ART) for at least 4 weeks prior to randomization and continue on ART as clinically indicated while enrolled on study. Viral serology only to be conducted if locally mandated and, if done, must be performed within 28 days of randomization.
Evidence of active infection that requires systemic antibacterial, antiviral, or antifungal therapy ≤ 7 days prior to the first dose of study intervention.
Live/attenuated vaccine received within 30 days of first treatment. The use of inactivated seasonal influenza vaccines (e.g., Fluzone®) will be permitted on study without restriction.
Any botanical preparation (e.g., herbal supplements or traditional Chinese medicines) intended to treat the disease under study within 4 weeks prior to treatment. The concurrent use of any botanical preparation is not permitted while on study.
Prior organ allograft.
History of allergy to study intervention or any of its components.
Known central nervous system (CNS) metastases or leptomeningeal disease is exclusionary unless adequately treated and the participant is no longer on steroids or anticonvulsants.
Participants unable to swallow oral medication or with gastrointestinal disorders that, per the treating physician's judgement, would likely to interfere with drug absorption, are excluded.
Pregnant or breastfeeding women are excluded.
History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or multiple allergies.
Radiographically detectable metastatic disease and/or locally advanced PDAC.
Anticipated need for preoperative radiation therapy (as determined per the treating medical team: medical oncologist and/or surgical oncologist at the time of study enrollment)
Radiographically detectable metastatic disease.
Cytotoxic chemotherapy or targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days prior to Cycle 1 Day 1.
Participants with more than one prior line of therapy are excluded.
Clinically significant persistent toxicities (CTCAE v5.0 Grade ≥2) caused by previous cancer therapy, excluding alopecia and Grade 2 neuropathy, are not allowed.
Cytotoxic chemotherapy or targeted therapy within 28 days of Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 14 or more days prior to Cycle 1 Day 1.
Participants with more than one prior line of therapy are excluded.
Clinically significant persistent toxicities (CTCAE v5.0 Grade ≥2) caused by previous cancer therapy, excluding alopecia and Grade 2 neuropathy, are not allowed
What this trial measures
- Safety and adverse events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0