Pancreatic Ductal Adenocarcinoma
Conditions
Keywords
PRMT5, MTAP, MRTX1719, MountainTAP, Pancreatic cancer, PDAC
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.
Interventions
DRUGBMS-986504
Specified dose on specified days
DRUGGemcitabine
Specified dose on specified days
DRUGNab-paclitaxel
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed