The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
700
INCA33890 will be administered at protocol defined dose.
Placebo will be administered at protocol defined dose.
Bevacizumab will be administered at protocol defined dose.
Progression-Free Survival (PFS)
Defined as the time from the date of randomization to the date of the first documented progression as determined by the investigator per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 or death due to any cause.
Time frame: Up to 3 years
Overall Survival (OS)
Defined as the time from the date of randomization to the date of death due to any cause.
Time frame: Up to 4 years
Objective response
Defined as complete response (CR) or partial response (PR) as determined by the investigator per RECIST v1.1.
Time frame: Up to 3 years
Duration of Response (DOR)
Defined as the time from the earliest date of documented response until the earliest date of disease progression as determined by the investigator per RECIST v1.1 or death due to any cause, whichever occurs first.
Time frame: Up to 3 years
Treatment Emergent Adverse Events (TEAEs)
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study treatment, up to 90 days after the last dose INCA33890/placebo (or 30 days after the last dose of any FOLFOX component or bevacizumab if later) or the start of new anticancer therapy, whichever comes first.
Time frame: Up to 4 years
TEAEs leading to dose interruptions, dose reductions or discontinuation of study treatmen
TEAEs leading to dose interruption or study drug discontinuation.
Time frame: Up to 4 years
Change from baseline in EQ-5D-5L score at protocol-defined visits
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FOLFOX will be administered at protocol defined dose.
Mitchell Cancer Institute
Mobile, Alabama, United States
NOT_YET_RECRUITINGThe University of Arizona Cancer Center
Tucson, Arizona, United States
NOT_YET_RECRUITINGRoche Tissue Diagnostics, Companion Diagnostics
Tucson, Arizona, United States
RECRUITINGMemorial Care Orange Coast Medical Center
Fountain Valley, California, United States
RECRUITINGProvidence Medical Foundation
Fullerton, California, United States
RECRUITINGCancer & Blood Research Center
Los Alamitos, California, United States
RECRUITINGUniversity of California Los Angeles Health
Los Angeles, California, United States
NOT_YET_RECRUITINGSarah Cannon Research Institute Scri Oncology Partners
Aurora, Colorado, United States
RECRUITINGHartford Hospital
Hartford, Connecticut, United States
NOT_YET_RECRUITINGGeorge Washington University
Washington D.C., District of Columbia, United States
NOT_YET_RECRUITING...and 270 more locations
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).
Time frame: Up to 4 years
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 (C30) at protocol-defined visits
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.
Time frame: Up to 4 years
Change from baseline in Functional Assessment of Cancer Therapy Colorectal Symptom Index (FCSI)-9 score at protocol-defined visits
The FCSI-9 is a 9-item questionnaire derived from the FACT-C questionnaire to be a briefer, more targeted symptom-specific measure for patients with CRC. The FCSI-9 assesses common symptoms of CRC, including energy, pain, weight loss, nausea, diarrhea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The questionnaire is scored to produce a single total score, with a higher score indicating less symptoms.
Time frame: Up to 4 years