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
Phase 3 – large-scale trial before approval
Conditions:
CRC (Colorectal Cancer)
Sponsor: Incyte Corporation
trial.available_in:
БГ
Overview
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.
Who can participate
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
19
Argentina (1)
Hospital Britanico de Buenos Aires
Buenos Aires
NOT_YET_RECRUITING
Australia (1)
Border Cancer Hospital Dispensary - Albury Wodonga Regional Cancer Centre
Albury , New South Wales
NOT_YET_RECRUITING
Belgium (1)
Universitair Ziekenhuis Brussel
Brussels
NOT_YET_RECRUITING
Brazil (1)
Fundacao Pio Xii Hospital de Cancer de Barretos
Barretos
NOT_YET_RECRUITING
Canada (1)
Cross Cancer Institute
Edmonton , Alberta
NOT_YET_RECRUITING
Denmark (1)
Aalborg Universitetshospital
Aalborg
NOT_YET_RECRUITING
France (1)
Institut de Cancerologie de L'Ouest
Angers
NOT_YET_RECRUITING
Georgia (1)
High Technology Hospital Medcenter
Batumi
NOT_YET_RECRUITING
Italy (1)
Azienda Ospedaliero Universitaria Delle Marche
Ancona
NOT_YET_RECRUITING
Japan (1)
Hyogo Cancer Center
Akashi-shi
NOT_YET_RECRUITING
Netherlands (1)
Meander Medisch Centrum
Amersfoort
NOT_YET_RECRUITING
Norway (1)
Haukeland Universitetssjukehus
Bergen
NOT_YET_RECRUITING
Poland (1)
Wojewodzkie Centrum Szpitalne Kotliny Jeleniogorskiej
Jelenia Góra
NOT_YET_RECRUITING
Puerto Rico (1)
Pan American Center For Oncology Trials Llc Dorado Office