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)

Phase 3Active Not RecruitingNCT07076121

Bristol-Myers Squibb470 enrolled

Overview

The purpose of this study is to assess the safety and efficacy of Navlimetostat (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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

470

Conditions

Pancreatic Ductal Adenocarcinoma

Interventions

NavlimetostatDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (269)

Mayo Clinic in Arizona - Phoenix

Phoenix, Arizona, United States

Local Institution - 0365

Tucson, Arizona, United States

Highlands Oncology Group

Springdale, Arkansas, United States

Scripps Green Hospital

La Jolla, California, United States

Local Institution - 0157

San Francisco, California, United States

Outcomes

Primary Outcomes

Progression-Free Survival as assessed by Response Evaluation Criteria in Solid Tumors version v1.1 (RECIST v1.1)

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

Time frame: Up to 3 years after last participant is randomized

Overall Survival (OS)

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

Time frame: Up to 3 years after last participant is randomized

Secondary Outcomes

Objective Response (OR) as assessed by RECIST v1.1

Time frame: Up to 3 years after last participant is randomized

Duration of Response (DOR) as assessed by RECIST v1.1

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 frame: Up to 3 years after last participant is randomized

Time to Objective Response (TTOR) as assessed by RECIST v1.1

Defined as the time between randomization to the date of the first documentation of objective tumor response

Time frame: Up to 3 years after last participant is randomized

Disease control as assessed by RECIST v1.1

Defined as the best overall response (BOR) of confirmed CR, PR, or stable disease (SD)

Time frame: Up to 3 years after last participant is randomized

Number of participants with treatment-related adverse events (TRAEs)

Time frame: Up to 28 days after the last drug administration

Number of participants with all-cause treatment-emergent adverse events (TEAEs)

Time frame: Up to 28 days after the last drug administration

Number of participants with treatment-emergent serious adverse events (TESAEs)

Time frame: Up to 28 days after the last drug administration

Number of participants with TEAEs leading to dose interruption, reduction, or discontinuation

Time frame: Up to 28 days after the last drug administration

Number of participants with laboratory abnormalities

Time frame: Up to 28 days after the last drug administration

PFS as assessed by RECIST v1.1

Time frame: Up to 3 years after last participant is randomized