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BMS-986504 with nab-paclitaxel and gemcitabine versus placebo with nab-paclitaxel and gemcitabine for untreated metastatic pancreatic ductal adenocarcinoma with MTAP deletion

A Randomized, Phase 2/3 Study Comparing BMS-986504 in Combination With Nab-paclitaxel and Gemcitabine Versus Placebo in Combination With Nab-paclitaxel and Gemcitabine in Participants With Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion

Phase2; Phase3 Interventional Bristol-Myers Squibb · NCT07076121

This trial will test whether adding BMS-986504 to standard nab-paclitaxel plus gemcitabine helps people with untreated metastatic pancreatic ductal adenocarcinoma whose tumors have a homozygous MTAP deletion.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment470 (estimated)
Ages18 Years and up
SexAll
SponsorBristol-Myers Squibb Industry-sponsored
Locations279 sites (Phoenix, Arizona and 278 other locations)
Trial IDNCT07076121 on ClinicalTrials.gov

What this trial studies

This randomized, placebo-controlled Phase 2/3 trial adds BMS-986504, a selective MTA-cooperative PRMT5 inhibitor, to standard nab-paclitaxel plus gemcitabine chemotherapy in participants with untreated metastatic pancreatic ductal adenocarcinoma and confirmed homozygous MTAP deletion. Participants must have measurable metastatic disease and generally no prior systemic therapy in the metastatic setting (one cycle of nab-paclitaxel/gemcitabine may be allowed before randomization). The study compares safety and anti-tumor activity of the combination versus chemotherapy plus placebo, using standard radiographic response criteria and clinical endpoints. Enrollment is restricted to patients whose tumor testing shows MTAP loss to enrich for tumors biologically susceptible to PRMT5 inhibition.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma, a homozygous MTAP deletion or loss on tumor testing, at least one measurable lesion, and no prior systemic therapy in the metastatic setting (one prior cycle of nab‑paclitaxel/gemcitabine may be allowed) are eligible.

Not a fit: Patients whose tumors do not have a homozygous MTAP deletion, who have received prior systemic therapy in the metastatic setting (beyond the allowed single cycle), or who have an active concurrent malignancy requiring treatment are unlikely to benefit from this targeted approach.

Why it matters

Potential benefit: If successful, adding BMS-986504 could improve outcomes for the subset of pancreatic cancer patients whose tumors have MTAP deletion when given with standard chemotherapy.

How similar studies have performed: Preclinical data and early-phase clinical work support targeting PRMT5 in MTAP-deleted tumors, but clinical success specifically in MTAP-deleted pancreatic cancer remains limited and still investigational.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC).
* Evidence of homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss detected in tumor tissue.
* Metastatic disease with at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1).
* Participants must not have received any systemic anticancer treatments in the metastatic setting.
* If clinically indicated and as per investigator discretion, participants may receive up to 1 cycle of Nab-paclitaxel/Gemcitabine (nab-p/gem) in the metastatic setting and must have not progressed or required discontinuation due to intolerable toxicity.
* Initial cycle of nab-p/gem administered in the metastatic setting must have been completed prior to randomization.

Exclusion Criteria:

* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Phoenix, Arizona and 278 other locations

+229 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pancreatic Ductal AdenocarcinomaPRMT5MTAPMRTX1719MountainTAPPancreatic cancerPDAC
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.