RECRUITING

A 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 With Homozygous MTAP Deletion (MountainTAP-30)

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Conditions

Pancreatic Ductal AdenocarcinomaPRMT5MTAPMRTX1719MountainTAPPancreatic cancerPDAC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the safety and efficacy of 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.

Official Title

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

Quick Facts

Study Start:2025-11-03
Study Completion:2029-05-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07076121

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Histologically or cytologically confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (PDAC).
  2. * Evidence of homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss detected in tumor tissue.
  3. * Metastatic disease with at least 1 measurable lesion as per Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1).
  4. * Participants must not have received any systemic anticancer treatments in the metastatic setting.
  5. * 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.
  6. * Initial cycle of nab-p/gem administered in the metastatic setting must have been completed prior to randomization.
  1. * Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.
  2. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0142
Phoenix, Arizona, 85054
United States
Local Institution - 0306
Springdale, Arkansas, 72762
United States
Local Institution - 0157
San Francisco, California, 94115
United States
Local Institution - 0139
Jacksonville, Florida, 32224
United States
Local Institution - 0132
Tampa, Florida, 33612
United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, 30060
United States
Local Institution - 0126
Boise, Idaho, 83712
United States
Local Institution - 0168
Chicago, Illinois, 60637
United States
Local Institution - 0125
Westwood, Kansas, 66205
United States
Local Institution - 0145
Baltimore, Maryland, 21287
United States
Local Institution - 0245
Boston, Massachusetts, 02114
United States
Local Institution - 0120
Boston, Massachusetts, 02215
United States
Local Institution - 0191
Detroit, Michigan, 48202
United States
Local Institution - 0192
Grand Rapids, Michigan, 49503
United States
Local Institution - 0182
Rochester, Minnesota, 55905
United States
Local Institution - 0290
Omaha, Nebraska, 68105
United States
Local Institution - 0144
Buffalo, New York, 14263
United States
Local Institution - 0146
New Hyde Park, New York, 11042
United States
Local Institution - 0143
New York, New York, 10016
United States
Local Institution - 0140
New York, New York, 10029
United States
Local Institution - 0279
New York, New York, 10065
United States
Local Institution - 0161
Rochester, New York, 14642
United States
Local Institution - 0129
Chapel Hill, North Carolina, 27514
United States
Local Institution - 0184
Portland, Oregon, 97227
United States
Local Institution - 0162
Portland, Oregon, 97239
United States
Local Institution - 0250
Bethlehem, Pennsylvania, 18015
United States
Local Institution - 0301
Lancaster, Pennsylvania, 17601
United States
Local Institution - 0158
Philadelphia, Pennsylvania, 19107
United States
Local Institution - 0289
Pittsburgh, Pennsylvania, 15232
United States
Local Institution - 0167
Nashville, Tennessee, 37203
United States
Local Institution - 0244
Nashville, Tennessee, 37203
United States
Local Institution - 0196
Dallas, Texas, 75246
United States
Local Institution - 0164
Houston, Texas, 77030
United States
Local Institution - 0159
Fairfax, Virginia, 22031
United States
Local Institution - 0348
Norfolk, Virginia, 23502
United States
Local Institution - 0337
Seattle, Washington, 98109
United States
Local Institution - 0195
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-11-03
Study Completion Date2029-05-03

Study Record Updates

Study Start Date2025-11-03
Study Completion Date2029-05-03

Terms related to this study

Keywords Provided by Researchers

  • PRMT5
  • MTAP
  • MRTX1719
  • MountainTAP
  • Pancreatic cancer
  • PDAC

Additional Relevant MeSH Terms

  • Pancreatic Ductal Adenocarcinoma