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)
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Interventions
- Registration Number
- NCT07076121
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 470
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A BMS-986504 - Arm A Gemcitabine - Arm A Nab-paclitaxel - Arm B BMS-986504 - Arm B Gemcitabine - Arm B Nab-paclitaxel - Arm C Gemcitabine - Arm C Nab-paclitaxel - Arm C Placebo - Arm D Gemcitabine - Arm D Nab-paclitaxel - Arm D Placebo - Arm E BMS-986504 - Arm E Gemcitabine - Arm E Nab-paclitaxel - Arm F Gemcitabine - Arm F Nab-paclitaxel - Arm F Placebo -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Objective Response (OR) as assessed by RECIST v1.1 Up to 3 years after last participant is randomized Duration of Response (DOR) as assessed by RECIST v1.1 Up to 3 years after last participant is randomized Defined as the time between the date of the first documentation of objective tumor response (complete response (CR) or partial response (PR)) and the date of disease progression or to death from any cause (whichever occurs first)
Time to Objective Response (TTOR) as assessed by RECIST v1.1 Up to 3 years after last participant is randomized Defined as the time between randomization to the date of the first documentation of objective tumor response
Disease control as assessed by RECIST v1.1 Up to 3 years after last participant is randomized Defined as the best overall response (BOR) of confirmed CR, PR, or stable disease (SD)
PFS as assessed by RECIST v1.1 Up to 3 years after last participant is randomized
Trial Locations
- Locations (258)
Local Institution - 0142
🇺🇸Phoenix, Arizona, United States
Local Institution - 0306
🇺🇸Springdale, Arkansas, United States
Local Institution - 0157
🇺🇸San Francisco, California, United States
Local Institution - 0139
🇺🇸Jacksonville, Florida, United States
Local Institution - 0132
🇺🇸Tampa, Florida, United States
Local Institution - 0193
🇺🇸Marietta, Georgia, United States
Local Institution - 0126
🇺🇸Boise, Idaho, United States
Local Institution - 0168
🇺🇸Chicago, Illinois, United States
Local Institution - 0125
🇺🇸Westwood, Kansas, United States
Local Institution - 0145
🇺🇸Baltimore, Maryland, United States
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