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

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.

Defined as having CR, PR, or stable disease (SD) as the best response determined by BICR per RECIST v1.1.

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.

Defined as CR or PR as determined by the investigator per RECIST v1.1.

Defined as the time from the earliest date of documented response until earliest date of disease progression as determined by the investigator per RECIST v1.1 or death from any cause.

Defined as having CR, PR, or SD as the best response as determined by the investigator per RECIST v1.1.

Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until 30 days after the last dose of study drug or the start of new anticancer therapy, whichever occurs first.

TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatment.

The EORTC QLQ-C30 is a validated, self-administered questionnaire developed to assess the quality of life in cancer patients. It consists of 30 questions divided into several subscales, including 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), a global health status/QoL scale, and a number of single-item measures that assess additional symptoms such as dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties.

The EORTC QLQ-PAN26 consists of 26 questions that assess 9 pancreatic cancer-related and treatment-related symptoms (pain, eating-related items, cachexia, hepatic symptoms, side effects, altered bowel habits, ascites, indigestion, and flatulence) and 5 emotional domains specific to pancreatic cancer (body image, healthcare satisfaction, sexuality, fear of future health, and ability to plan for the future). The QLQ-PAN26 is scored on a 4-point scale that ranges from not at all to very much.

The EQ-5D-5L is a validated, self-reported instrument for assessing HRQoL across 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels of severity, ranging from no problems to extreme problems. The questionnaire also includes a visual analog scale for self-rated overall health on a scale from 0 (worst imaginable health) to 100 (best imaginable health).