UPCC 14225 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

Study on Investigational Medication for Metastatic Pancreatic Cancer

Enrolling By Invitation
18 years or above
All
Phase 2/3
470 participants needed
1 Location

Brief description of study

The purpose of this study is to assess the safety and efficacy of Navlimetostat (BMS-986504), a selective, MTA-cooperative PRMT5 inhibitor, in combination with Nab-paclitaxel/Gemcitabine (nab-p/gem) versus placebo in combination with nab-p/gem, in participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) with homozygous methylthioadenosine phosphorylase (MTAP) deletion.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Pancreatic Ductal Adenocarcinoma
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the effects of an investigational medication combined with nab-paclitaxel and gemcitabine compared to a placebo with the same combination in people with untreated metastatic pancreatic ductal adenocarcinoma (PDAC) who have a specific genetic deletion called homozygous MTAP deletion. The study aims to explore the safety and efficacy of this treatment.

Participants will be randomly assigned to receive either the investigational medication or a placebo, both in combination with nab-paclitaxel and gemcitabine. The study procedures include regular monitoring, imaging tests, and assessments to measure the response of the cancer to the treatment. A placebo used in this study is an inactive substance that looks like the investigational medicine but does not contain any medicine.

  • Who can participate: Adults with metastatic pancreatic ductal adenocarcinoma and a confirmed homozygous MTAP deletion, who have not received prior systemic treatment for metastatic cancer, can participate.
  • Study details: Participants will be assigned to receive either the investigational medication or a placebo, along with other treatments. They will undergo regular health checks and imaging tests to track the progress of their treatment.
Updated on 03 Jun 2026. Study ID: 25-1648
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