Pumitamig + Chemotherapy for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment option for colorectal cancer that has spread and cannot be surgically removed. Researchers aim to determine if combining the experimental drug pumitamig with chemotherapy is safer and more effective than the current combination of bevacizumab with chemotherapy. Individuals diagnosed with colorectal cancer that has not yet been treated and lacks certain genetic markers might find this trial suitable. As a Phase 2 trial, the study measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to important research.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that pumitamig, when combined with chemotherapy, is generally safe and well-tolerated by patients. Earlier studies found no new safety issues, and only a few patients discontinued the treatment, indicating that most can manage the side effects without quitting.
Bevacizumab is another treatment that the FDA has approved for several cancers, including colorectal cancer, confirming its safety for cancer treatment.
Overall, both pumitamig and bevacizumab, when used with chemotherapy, have demonstrated safety for patients. Specifically, pumitamig has a low rate of treatment discontinuation due to side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Pumitamig in combination with chemotherapy for colorectal cancer because it offers a novel approach compared to standard treatments like FOLFOX or FOLFIRI regimens. Pumitamig works by specifically targeting and inhibiting certain pathways that contribute to cancer cell growth, which could potentially enhance the effectiveness of chemotherapy. Additionally, unlike traditional therapies, Pumitamig may offer a more tailored treatment by working synergistically with Bevacizumab, a drug that inhibits blood vessel formation in tumors. This combination could lead to better outcomes by attacking the cancer on multiple fronts.
What evidence suggests that this trial's treatments could be effective for colorectal cancer?
Research has shown that pumitamig, when combined with chemotherapy, may improve outcomes for solid tumors like colorectal cancer. Early results suggest this combination can be effective, especially for patients without certain genetic markers such as dMMR, MSI-H, and BRAF V600E. Pumitamig targets cancer cells more precisely, potentially enhancing the effects of chemotherapy. In this trial, some participants will receive pumitamig with chemotherapy, while others will receive bevacizumab, known for treating colorectal cancer by cutting off the blood supply to tumors. Both treatments are tested in separate arms to determine which works better with chemotherapy in fighting this type of cancer.12367
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for individuals with colorectal cancer that hasn't been treated before and can't be removed by surgery or has spread to other parts of the body. Specific eligibility details are not provided, but typically participants must meet certain health standards and may need to agree to specific study requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pumitamig in combination with chemotherapy or bevacizumab in combination with chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Pumitamig
Trial Overview
The trial is testing the safety and effectiveness of a new treatment called Pumitamig when used with chemotherapy (FOLFOX, FOLFIRI, or CAPOX) compared to an existing treatment, Bevacizumab with the same chemo options in patients with advanced colorectal cancer.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
BioNTech SE
Industry Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University
Citations
NCT07221357 | A Study to Evaluate the Safety and ...
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in ...
Gastrointestinal is next for pumitamig | ApexOnco
The first of the two studies, Rosetta CRC-203, will enrol first-line colorectal cancer patients who are negative for dMMR, MSI-H and BRAF V600E ...
study connect - BMS Clinical Trials
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in ...
4.
investors.biontech.de
investors.biontech.de/news-releases/news-release-details/first-disclosure-global-interim-phase-2-data-biontech-andPress Release - BioNTech
“Today's data add to the growing body of evidence indicating the potential of pumitamig to improve outcomes across a wide range of solid tumors, ...
5.
withpower.com
withpower.com/trial/phase-2-and-3-untreated-unresectable-or-metastatic-colorectal-cancer-2-2026-b51ecPumitamig + Chemotherapy for Colorectal Cancer
The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with ...
Pfizer moves into the VEGF bispecific fast lane | ApexOnco
A pivotal colorectal cancer trial of pumitamig, and Summit's own ivonescimab phase 3 study, are imminent, though the latter hasn't yet got a ...
PD-L1xVEGF-A bispecific antibody pumitamig (BNT327/ ...
Pumitamig plus chemotherapy demonstrated a manageable safety profile with no new safety signals and a low discontinuation rate. The data are ...
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