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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
470
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0142
Phoenix, Arizona, United States
NOT_YET_RECRUITINGLocal Institution - 0365
Tucson, Arizona, United States
NOT_YET_RECRUITINGHighlands Oncology Group
Springdale, Arkansas, United States
RECRUITINGLocal Institution - 0373
La Jolla, California, United States
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
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
PFS as assessed by RECIST v1.1
Time frame: Up to 3 years after last participant is randomized
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Local Institution - 0157
San Francisco, California, United States
NOT_YET_RECRUITINGLocal Institution - 0369
Jacksonville, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0139
Jacksonville, Florida, United States
NOT_YET_RECRUITINGLocal Institution - 0132
Tampa, Florida, United States
WITHDRAWNLocal Institution - 0367
Atlanta, Georgia, United States
NOT_YET_RECRUITINGNorthwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia, United States
RECRUITING...and 266 more locations