The purpose of this study is to evaluate the efficacy and safety of standard chemotherapy with or without INCB161734 in participants with metastatic pancreatic ductal adenocarcinoma (PDAC).
Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation
No prior systemic treatment in the metastatic setting
ECOG Performance status 0-1
Adequate organ function
Prior treatment with any KRAS inhibitor
Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug
Known active CNS metastases
Parallel
INCB161734
DrugOral; tablet
Placebo
DrugOral; tablet
Investigator's choice of chemotherapy
DrugThe investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause.
Progression-free survival (PFS) by BICR
Defined as the time from the date of randomization to the date of the first documented progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.
Objective Response by BICR
Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.
Duration of Response (DOR) by BICR
Defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by BICR per RECIST v1.1 or death from any cause.
Disease control by BICR
Defined as having CR, PR, or stable disease (SD) as the best response determined by BICR per RECIST v1.1.
Progression-Free Survival (PFS) by investigator assessment
Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per RECIST v1.1 or death due to any cause.
Objective response by investigator assessment
Defined as CR or PR as determined by the investigator per RECIST v1.1.
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Incyte Corporation
Lead sponsor
Qiagen Manchester Ltd
Collaborator
