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

Purpose

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.

Condition

  • CRC (Colorectal Cancer)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
INCA33890 		INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
  • Drug: INCA33890
    INCA33890 will be administered at protocol defined dose.
  • Drug: Bevacizumab
    Bevacizumab will be administered at protocol defined dose.
  • Drug: FOLFOX
    FOLFOX will be administered at protocol defined dose.
Placebo Comparator
Placebo 		Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.
  • Drug: Placebo
    Placebo will be administered at protocol defined dose.
  • Drug: Bevacizumab
    Bevacizumab will be administered at protocol defined dose.
  • Drug: FOLFOX
    FOLFOX will be administered at protocol defined dose.

Recruiting Locations

Roche Tissue Diagnostics, Companion Diagnostics
Tucson, Arizona 85755

Memorial Care Orange Coast Medical Center
Fountain Valley, California 92708

Sarah Cannon Research Institute Scri Oncology Partners
Aurora, Colorado 80012

Florida Oncology & Hematology
Fort Myers, Florida 33912

Community Health Network, Inc.
Indianapolis, Indiana 46250

Hematology Oncology of Indiana
Indianapolis, Indiana 46260

Cancer Center For Blood Disorders A Division of American Oncology Partners P.A
Bethesda, Maryland 20817

Sarah Cannon Research Institute Scri Oncology Partners
Brandywine, Maryland 20613

Missouri Cancer Associates
Columbia, Missouri 65201

Midamerica Cancer Care
Kansas City, Missouri 64121

Oncology Hematology Associates
Springfield, Missouri 65807

Washington University School of Medicine
St Louis, Missouri 63110

Presbyterian Rust Medical Center
Rio Rancho, New Mexico 87124

Messino Cancer Center
Asheville, North Carolina 28806

Alliance Cancer Specialists
Doylestown, Pennsylvania 18901

Cancer Care Associates of York
York, Pennsylvania 17403

Provision Center For Biomedical Research
Knoxville, Tennessee 37909

Texas Oncology
Austin, Texas 78745

Shenandoah Oncology
Winchester, Virginia 22601

Pan American Center For Oncology Trials Llc Dorado Office
Dorado, Puerto Rico 00646

More Details

Status
Recruiting
Sponsor
Incyte Corporation

Study Contact

Incyte Corporation Call Center (US)
1.855.463.3463
medinfo@incyte.com