A Study 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
Recruiting · NCT07221357 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 25 US states.
- Local Institution - 0428 - Tucson, Arizona, United States
- Highlands Oncology Group - Springdale, Arkansas, United States
- USC/Norris Comprehensive Cancer Center - Los Angeles, California, United States
- Local Institution - 0330 - Los Angeles, California, United States
- University of California, Irvine (UCI) Health - UC Irvine Medical Center - Orange, California, United States
- Local Institution - 0317 - San Francisco, California, United States
- Florida Cancer Specialists - East - Cape Coral, Florida, United States
- Florida Cancer Specialists - North - St. Petersburg, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Local Institution - 0326 - Atlanta, Georgia, United States
- Northside Hospital - Atlanta, Georgia, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital - Marietta, Georgia, United States
- Local Institution - 0433 - Chicago, Illinois, United States
- Local Institution - 0638 - Fort Wayne, Indiana, United States
- Local Institution - 0335 - Iowa City, Iowa, United States
- Local Institution - 0262 - Baltimore, Maryland, United States
- Maryland Oncology Hematology - Silver Spring - Silver Spring, Maryland, United States
- Local Institution - 0471 - Boston, Massachusetts, United States
- Local Institution - 0430 - Ann Arbor, Michigan, United States
- Local Institution - 0254 - Grand Rapids, Michigan, United States
- Minnesota Oncology - Maple Grove, Minnesota, United States
- Local Institution - 0318 - Kansas City, Missouri, United States
- Washington University School OF Medicine-Siteman Cancer Center - St Louis, Missouri, United States
- University Of Nebraska Medical Center - Omaha, Nebraska, United States
- Northwell Health/ RJ Zuckerberg Cancer Center - Lake Success, New York, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone - Mineola, New York, United States
- New York Cancer and Blood Specialists - Shirley, New York, United States
- Local Institution - 0290 - Charlotte, North Carolina, United States
- Sanford Fargo Medical Center - Fargo, North Dakota, United States
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center - Columbus, Ohio, United States
- Lehigh Valley Health Network - Allentown, Pennsylvania, United States
- Local Institution - 0604 - Pittsburgh, Pennsylvania, United States
- Sanford Cancer Center - Sioux Falls, South Dakota, United States
- Local Institution - 0333 - Nashville, Tennessee, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North - Arlington, Texas, United States
- Texas Oncology, PA - Austin, Texas, United States
- Baylor College of Medicine Medical Center - Houston, Texas, United States
- Texas Oncology - San Antonio - San Antonio, Texas, United States
- Local Institution - 0426 - Salt Lake City, Utah, United States
- Local Institution - 0278 - Fairfax, Virginia, United States
- Virginia Oncology Associates - Norfolk, Virginia, United States
- Local Institution - 0491 - Edmonds, Washington, United States
- Local Institution - 0253 - Seattle, Washington, United States
- Local Institution - 0629 - Spokane, Washington, United States
- Northwest Cancer Specialists, P.C. - Vancouver, Washington, United States
- Local Institution - 0020 - Adana, Turkey (Türkiye)
- Local Institution - 0065 - Ankara, Turkey (Türkiye)
- Local Institution - 0609 - Avellino, Italy
- Institut Català d'Oncologia (ICO) - Badalona - Badalona, Spain
- Local Institution - 0610 - Bari, Italy
- Local Institution - 0409 - Beijing, China
- Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin - Berlin, Germany
- St. Josef und St. Elisabeth Hospital gGmbH - Bochum, Germany
- Local Institution - 0118 - Brussels, Belgium
- Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) - Buenos Aires, Argentina
- Velindre Cancer Centre - Cardiff, United Kingdom
- Azienda Ospedaliera Garibaldi - Catania, Italy
- Local Institution - 0588 - Chemnitz, Germany
- Local Institution - 0653 - Chihuahua City, Mexico
Showing 60 of 283 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →