Trial comparing treatments for Untreated, Unresectable, or Metastatic Colorectal Cancer
Official title 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
ClinicalTrials.gov ID: NCT07221357
What this study is testing
What is Pumitamig?
Pumitamig is an investigational medicine being studied as a potential treatment for untreated, unresectable, or metastatic colorectal cancer.
Also referred to as BMS-986545, BNT327, PM8002.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether pumitamig plus chemotherapy is safe and works as well as bevacizumab plus chemotherapy for colorectal cancer.
- Who it's for
- You may be able to join if you have colorectal cancer that has not been treated, cannot be removed, or has spread.
- What's involved
- You will receive either pumitamig or bevacizumab along with chemotherapy. You will have regular visits and tests to check safety and how well the treatment works.
- Time commitment
- The study lasts several months and requires multiple clinic visits for treatment and monitoring.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular...
- 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...
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Springdale, Arkansas, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Francisco, California, United States
- Cape Coral, Florida, United States
- St. Petersburg, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Iowa City, Iowa, United States
- Silver Spring, Maryland, United States
- Maple Grove, Minnesota, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- Lake Success, New York, United States
- Mineola, New York, United States
- Shirley, New York, United States
- Fargo, North Dakota, United States
- Columbus, Ohio, United States
+ 167 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Springdale, Arkansas, United States; Los Angeles, California, United States; Orange, California, United States; San Francisco, California, United States; Cape Coral, Florida, United States; St. Petersburg, Florida, United States and 181 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.