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NCT07076121

A Study Comparing Navlimetostat (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)

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~470 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:NavlimetostatGemcitabineNab-paclitaxelPlacebo

At a glance

Recruiting sites
0 of 269 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)
Measured over Up to 3 years after last participant is randomized
+1 more outcome measured

Conditions

Pancreatic Ductal Adenocarcinoma

Explore related trials

Pancreatic Ductal AdenocarcinomaMTAP Gene

Where it's being run

269 sites across 182 states
New York7
Pennsylvania5
Romania5
Texas4
Germany4
Taiwan4
Turkey (Türkiye)4
Brazil3

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to screening.

What this trial measures

  • Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)Up to 3 years after last participant is randomized

    Defined as the time between the randomization date and the date of progressive disease (PD) or death from any cause (whichever occurs first)

  • Overall Survival (OS)Up to 3 years after last participant is randomized

    Defined as the time from the randomization date to the date of death from any cause