Recruiting
Phase 3

Chemotherapy & Bevacizumab with INCA33890

Sponsor:

Incyte Corporation

Code:

NCT07284849

Conditions

CRC (Colorectal Cancer)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INCA33890

Placebo

Bevacizumab

FOLFOX

Study Details

Brief summary:

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.

Conditions

CRC (Colorectal Cancer)

Study ID

NCT07284849

Start date

Mar 5, 2026

Status verified date

Oct, 2026

Completion date

Sep 28, 2029

Anticipated

Primary completion date

Dec 29, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

700 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: INCA33890

INCA33890 will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.

placebo comparator: Placebo

Placebo will be administered in combination with bevacizumab and FOLFOX at the protocol-defined dose.

Interventions

INCA33890

INCA33890 will be administered at protocol defined dose.

Placebo

Placebo will be administered at protocol defined dose.

Bevacizumab

Bevacizumab will be administered at protocol defined dose.

FOLFOX

FOLFOX will be administered at protocol defined dose.

Primary outcome measure

  • Progression-Free Survival (PFS) [ Time Frame: Up to 3 years ]

Central Contacts and Locations

Central contacts

Incyte Corporation Call Center (US)

1.855.463.3463medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

+800 00027423eumedinfo@incyte.com

Locations

The University of Arizona Cancer Center

Recruiting

Tucson, Arizona, United States, 85719

Roche Tissue Diagnostics, Companion Diagnostics

Recruiting

Tucson, Arizona, United States, 85755

Memorial Care Orange Coast Medical Center

Recruiting

Fountain Valley, California, United States, 92708

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Cancer & Blood Research Center

Recruiting

Los Alamitos, California, United States, 90720

Sarah Cannon Research Institute Scri Oncology Partners

Recruiting

Aurora, Colorado, United States, 80012

Florida Oncology & Hematology

Recruiting

Fort Myers, Florida, United States, 33912

University of Florida Health

Recruiting

Gainesville, Florida, United States, 32610

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Ascension Sacred Heart Pensacola

Recruiting

Pensacola, Florida, United States, 32504

Piedmont Cancer Institute

Recruiting

Locust Grove, Georgia, United States, 30248

Sih Cancer Institute

Recruiting

Carterville, Illinois, United States, 62918

University of Illinois Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62703

Community Health Network, Inc.

Recruiting

Indianapolis, Indiana, United States, 46250

Hematology Oncology of Indiana

Recruiting

Indianapolis, Indiana, United States, 46260

Saint Agnes Hospital

Recruiting

Baltimore, Maryland, United States, 21229-5201

Cancer Center For Blood Disorders A Division of American Oncology Partners P.A

Recruiting

Bethesda, Maryland, United States, 20817

Sarah Cannon Research Institute Scri Oncology Partners

Recruiting

Brandywine, Maryland, United States, 20613

Trinity Health St Joseph Mercy Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48197

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

Saint Luke'S Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Midamerica Cancer Care

Recruiting

Kansas City, Missouri, United States, 64121

Oncology Hematology Associates

Recruiting

Springfield, Missouri, United States, 65807

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Presbyterian Rust Medical Center

Recruiting

Rio Rancho, New Mexico, United States, 87124

Ny Cancer and Blood Specialists

Recruiting

Shirley, New York, United States, 11967

Messino Cancer Center

Recruiting

Asheville, North Carolina, United States, 28806

The University of North Carolina At Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Alliance Cancer Specialists

Recruiting

Doylestown, Pennsylvania, United States, 18901

Allegheny General Hospital Cancer Institute

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Cancer Care Associates of York

Recruiting

York, Pennsylvania, United States, 17403

Avera Cancer Institute

Recruiting

Sioux Falls, South Dakota, United States, 57105

Provision Center For Biomedical Research

Recruiting

Knoxville, Tennessee, United States, 37909

Ascension Seton Spclty Care Ctr

Recruiting

Austin, Texas, United States, 78712

Texas Oncology

Recruiting

Austin, Texas, United States, 78745

Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Hematology Oncology Associates of Fredericksburg Admin

Recruiting

Fredericksburg, Virginia, United States, 22408

Shenandoah Oncology

Recruiting

Winchester, Virginia, United States, 22601

West Virginia University Cancer Institute

Recruiting

Morgantown, West Virginia, United States, 26506

Thedacare Medical Oncology

Recruiting

Appleton, Wisconsin, United States, 54911

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Hotel-Dieu de Levis

Recruiting

Lévis, Quebec, Canada, G6V 3Z1

More Information

Sponsor

Incyte Corporation

Last update posted

Oct 9, 2026

Last verified

Oct, 2026

Keywords

  • Metastatic Colorectal Cancer
  • Colon Cancer
  • INCA33890

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Incyte Corporation on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.