A Phase II Study Evaluating BMS-986504 in MTAP-deleted Pancreatic Cancer

NCT07283705 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2025-0804NCI-2025-09221
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Phase 2 Study; BMS-986504; MTAP-deleted Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Safety and adverse events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (3)

Cohort 1

EXPERIMENTAL

Will receive a combination of BMS-986504, gemcitabine, and nab-paclitaxel for 4 treatment cycles.

Drug: BMS-986504; Drug: Gemcitabine; Drug: Nab-paclitaxel

Cohort 2

EXPERIMENTAL

Will receive a combination of BMS-986504, gemcitabine, and nab-paclitaxel for 4-6 months, followed by Maintenance Therapy with BMS-986504 by itself for as long as the disease does not get worse.

Drug: BMS-986504; Drug: Gemcitabine; Drug: Nab-paclitaxel

Cohort 3

EXPERIMENTAL

Will receive a combination of BMS-986504, and the combination treatment mFOLFIRINOX (oxaliplatin, irinotecan, and 5-fluorouracil) for 4-6 months.

Drug: BMS-986504; Drug: mFOLFIRINOX

Interventions

BMS-986504 DRUG

Given by po

Cohort 1; Cohort 2; Cohort 3

Gemcitabine DRUG

Given by IV

Cohort 1; Cohort 2

Nab-paclitaxel DRUG

Given by IV

Cohort 1; Cohort 2

mFOLFIRINOX DRUG

Given by iv

Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Gemcitabine; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Maria P Morelli, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria P Morelli, MD

CONTACT

713-745-1297; giclinicaltrials@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 16, 2025
• Study Start (Estimated): May 18, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2031
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

US (1)