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)

Purpose

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.

Condition

  • Pancreatic Ductal Adenocarcinoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A
  • Drug: BMS-986504
    Specified dose on specified days
    Other names:
    • MRTX1719
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Nab-paclitaxel
    Specified dose on specified days
    Other names:
    • Abraxane
Experimental
Arm B
  • Drug: BMS-986504
    Specified dose on specified days
    Other names:
    • MRTX1719
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Nab-paclitaxel
    Specified dose on specified days
    Other names:
    • Abraxane
Placebo Comparator
Arm C
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Nab-paclitaxel
    Specified dose on specified days
    Other names:
    • Abraxane
  • Drug: Placebo
    Specified dose on specified days
Placebo Comparator
Arm D
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Nab-paclitaxel
    Specified dose on specified days
    Other names:
    • Abraxane
  • Drug: Placebo
    Specified dose on specified days
Experimental
Arm E
  • Drug: BMS-986504
    Specified dose on specified days
    Other names:
    • MRTX1719
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Nab-paclitaxel
    Specified dose on specified days
    Other names:
    • Abraxane
Placebo Comparator
Arm F
  • Drug: Gemcitabine
    Specified dose on specified days
  • Drug: Nab-paclitaxel
    Specified dose on specified days
    Other names:
    • Abraxane
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

Highlands Oncology Group
Springdale 4132093, Arkansas 4099753 72762
Contact:
J.Thaddeus Beck, Site 0306
479-872-8130

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta 4207783, Georgia 4197000 30060
Contact:
Walid Shaib, Site 0193
770-281-5124

The Cancer & Hematology Centers
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Sreenivasa Chandana, Site 0192
269-993-6056

University Of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68105
Contact:
Kelsey Klute, Site 0290
701-471-0277

Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success 5123853, New York 5128638 11042
Contact:
Daniel King, Site 0146
516-734-8900

Kaiser Permanente Center for Health Research
Portland 5746545, Oregon 5744337 97227
Contact:
Sandeep Mashru, Site 0184
503-249-3315

St. Luke's University Health Network
Bethlehem 5180225, Pennsylvania 6254927 18015
Contact:
Yull Arriaga, Site 0250
214-995-1863

SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
Contact:
Meredith Pelster, Site 0244
615-986-4366

Texas Oncology - DFW
Dallas 4684888, Texas 4736286 75246
Contact:
Andrew Paulson, Site 0196
214-549-5525

University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Contact:
Shubham Pant, Site 0164
713-745-4538

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com