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Purpose

The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer

Condition

Eligibility

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

Inclusion Criteria

  • Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery. - Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used). - Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing. - Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Exclusion Criteria

  • Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression. - Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence. - Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome. - Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A1
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
  • Drug: FOLFOX
    Specified dose on specified days
  • Drug: FOLFIRI
    Specified dose on specified days
Experimental
Arm A2
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
  • Drug: FOLFOX
    Specified dose on specified days
  • Drug: FOLFIRI
    Specified dose on specified days
Other
Arm B
  • Drug: FOLFOX
    Specified dose on specified days
  • Drug: FOLFIRI
    Specified dose on specified days
  • Drug: Bevacizumab
    Specified dose on specified days
Experimental
Arm C
  • Drug: Pumitamig
    Specified dose on specified days
    Other names:
    • BMS-986545
    • BNT327
    • PM8002
  • Drug: FOLFOX
    Specified dose on specified days
  • Drug: FOLFIRI
    Specified dose on specified days
  • Drug: CAPOX
    Specified dose on specified days
Other
Arm D
  • Drug: FOLFOX
    Specified dose on specified days
  • Drug: FOLFIRI
    Specified dose on specified days
  • Drug: Bevacizumab
    Specified dose on specified days
  • Drug: CAPOX
    Specified dose on specified days

Recruiting Locations

USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Sandra Algaze, Site 0263
818-406-8072

University of California, Irvine (UCI) Health - UC Irvine Medical Center
Orange, California 92868
Contact:
Farshid Dayyani, Site 0345
714-456-5153

Florida Cancer Specialists - East
Cape Coral, Florida 33990
Contact:
Todd Gersten, Site 0574
561-366-4100

Florida Cancer Specialists - North
St. Petersburg, Florida 33705
Contact:
Maen Hussein, Site 0575
727-216-1143

Moffitt Cancer Center
Tampa, Florida 33612
Contact:
Tiago Biachi de Castria, Site 0269
646-673-0129

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta, Georgia 30060
Contact:
Walid Shaib, Site 0369
770-281-5124

Maryland Oncology Hematology - Silver Spring
Silver Spring, Maryland 20904
Contact:
Danubia Hester, Site 0580

Minnesota Oncology
Maple Grove, Minnesota 55369
Contact:
Robert Delaune, Site 0572

Washington University School OF Medicine-Siteman Cancer Center
St Louis, Missouri 63110
Contact:
Moh'd Khushman, Site 0336
314-273-3564

University Of Nebraska Medical Center
Omaha, Nebraska 68198
Contact:
Laura Tenner, Site 0334
402-559-5600

Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York 11042
Contact:
Nicholas Hornstein, Site 0429
323-533-7275

Sanford Fargo Medical Center
Fargo, North Dakota 58102
Contact:
Jeffrey Wiisanen, Site 0526
701-234-2358

Lehigh Valley Health Network
Allentown, Pennsylvania 18103
Contact:
Maged Khalil, Site 0348

Sanford Cancer Center
Sioux Falls, South Dakota 57104
Contact:
Jonathan Bleeker, Site 0312
605-328-8000

SCRI Oncology Partners
Nashville, Tennessee 37203
Contact:
Meredith Pelster, Site 0570
615-986-4366

Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North
Arlington, Texas 76012
Contact:
Laith Abushahin, Site 0573

Texas Oncology, PA
Austin, Texas 78705
Contact:
Vivian Cline, Site 0571
512-427-9400

Texas Oncology - San Antonio
San Antonio, Texas 78240
Contact:
Sridhar Beeram, Site 0576
210-615-1988

Virginia Oncology Associates
Norfolk, Virginia 23502
Contact:
YUE ZHANG, Site 0577
757-466-8683

Northwest Cancer Specialists, P.C.
Vancouver, Washington 98684
Contact:
Spencer Shao, Site 0578
503-528-5005

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.