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)

Bristol-Myers Squibb (BMS)

Status and phase

Begins enrollment in 3 months

Phase 3

Phase 2

Conditions

Pancreatic Ductal Adenocarcinoma

Treatments

Drug: BMS-986504

Drug: Placebo

Drug: Nab-paclitaxel

Drug: Gemcitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT07076121

U1111-1320-4708 (Other Identifier)

2025-522598-12 (Other Identifier)

CA240-0030

Details and patient eligibility

About

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.

Enrollment

470 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

470 participants in 6 patient groups, including a placebo group

Arm A

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: BMS-986504

Arm B

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: BMS-986504

Arm C

Placebo Comparator group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: Placebo

Arm D

Placebo Comparator group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: Placebo

Arm E

Experimental group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: BMS-986504

Arm F

Placebo Comparator group

Treatment:

Drug: Gemcitabine

Drug: Nab-paclitaxel

Drug: Placebo

Trial contacts and locations

259

Central trial contact

First line of the email MUST contain the NCT# and Site #.; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

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