A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

Condition(s) studied

Investigational drug(s) / intervention(s)

INCB161734: Oral; tablet

Placebo: Oral; tablet

Investigator's choice of chemotherapy: The investigator will select the chemotherapy in accordance with the protocol-defined requirements. The possible choices as defined by the protocol:

Study summary

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).

Eligibility

Primary outcome measure(s)

• Overall Survival (OS) — Up to approximately 3 years
  Defined as the time from the date of randomization to the date of death due to any cause.
• Progression-free survival (PFS) by BICR — Up to approximately 2 years
  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 — Up to approximately 2 years
  Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.

Trial sites (229)

+ 189 more sites — see the full list on the official registry below.