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A Study 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
A Study 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

NCT07284849

RecruitingPhase 3

Sponsor: Incyte Corporation

Conditions: CRC (Colorectal Cancer)

Interventions: INCA33890, Placebo, Bevacizumab, FOLFOX

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Stage IV colorectal adenocarcinoma not amenable to curative resection.
* No prior systemic treatment for unresectable or metastatic disease. Participants who received adjuvant or neoadjuvant therapy may enroll if there was no recurrence within 12 months of the end of treatment.
* Measurable disease per RECIST v1.1.
* ECOG performance status of 0 or 1.
* Adequate organ function determined by laboratory results.

Exclusion Criteria:

* MSI-H/dMMR per historical data in the medical record.
* BRAF V600E mutation per historical data in the medical record.
* Untreated and/or progressing CNS metastases.
* History of other malignancy within 2 years.
* Treatment with an anti-PD-(L)1 or other immune checkpoint inhibitor for any indication within the last 3 years.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* Significant concurrent and/or uncontrolled medical condition.
* History of organ transplant, including allogeneic stem cell transplantation.

Other protocol-defined inclusion/exclusion criteria apply.
Locations (254)
  • Mobile, Alabama, United States
  • Tucson, Arizona, United States
  • Tucson, Arizona, United States
  • Fountain Valley, California, United States
  • Fullerton, California, United States
  • Los Alamitos, California, United States
  • Los Angeles, California, United States
  • Aurora, Colorado, United States
  • Hartford, Connecticut, United States
  • Washington D.C., District of Columbia, United States
  • Fort Myers, Florida, United States
  • Gainesville, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Pensacola, Florida, United States
  • Tampa, Florida, United States
  • Locust Grove, Georgia, United States
  • Honolulu, Hawaii, United States
  • Boise, Idaho, United States
  • Carterville, Illinois, United States
  • Chicago, Illinois, United States
  • Evanston, Illinois, United States
  • Springfield, Illinois, United States
  • Indianapolis, Indiana, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Baltimore, Maryland, United States
  • Bethesda, Maryland, United States
  • Brandywine, Maryland, United States
  • + 224 more on CT.gov