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
| Arm | Description | Assigned Intervention |
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Experimental Arm A |
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Experimental Arm B |
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Placebo Comparator Arm C |
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Placebo Comparator Arm D |
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Experimental Arm E |
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Placebo Comparator Arm F |
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Recruiting Locations
Highlands Oncology Group
Springdale 4132093, Arkansas 4099753 72762
Springdale 4132093, Arkansas 4099753 72762
Contact:
J.Thaddeus Beck, Site 0306
479-872-8130
J.Thaddeus Beck, Site 0306
479-872-8130
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta 4207783, Georgia 4197000 30060
Marietta 4207783, Georgia 4197000 30060
Contact:
Walid Shaib, Site 0193
770-281-5124
Walid Shaib, Site 0193
770-281-5124
Kaiser Permanente Center for Health Research
Portland 5746545, Oregon 5744337 97227
Portland 5746545, Oregon 5744337 97227
Contact:
Sandeep Mashru, Site 0184
503-249-3315
Sandeep Mashru, Site 0184
503-249-3315
St. Luke's University Health Network
Bethlehem 5180225, Pennsylvania 6254927 18015
Bethlehem 5180225, Pennsylvania 6254927 18015
Contact:
Arturo Loaiza-Bonilla, Site 0250
215-615-5810
Arturo Loaiza-Bonilla, Site 0250
215-615-5810
SCRI Oncology Partners
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
Contact:
Meredith Pelster, Site 0244
615-986-4366
Meredith Pelster, Site 0244
615-986-4366
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com