Pumitamig + Chemotherapy for Colorectal Cancer

Not yet recruiting at 192 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Checkpoint inhibitors

Disqualifiers: CNS metastases, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 years

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

My colorectal cancer is not known to be mismatch repair deficient or have high microsatellite instability.

My cancer does not have the BRAF V600E mutation.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

I haven't had major heart issues or uncontrolled high blood pressure in the last 6 months.

I haven't had treatments targeting immune checkpoints or specific cancer immunotherapies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pumitamig in combination with chemotherapy or bevacizumab in combination with chemotherapy

Up to 5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Arm D Experimental Treatment 4 Interventions

Group II: Arm C Experimental Treatment 4 Interventions

Group III: Arm B Experimental Treatment 3 Interventions

Group IV: Arm A2 Experimental Treatment 3 Interventions

Group V: Arm A1 Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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

Trials

84

Recruited

120,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07221357

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 ...

2. oncologypipeline.com oncologypipeline.com/apexonco/gastrointestinal-next-pumitamig

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 ...

3. bmsstudyconnect.com bmsstudyconnect.com/no/en/clinical-trials/NCT07221357.html

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-and

Press 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-b51ec

Pumitamig + 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 ...

6. oncologypipeline.com oncologypipeline.com/apexonco/pfizer-moves-vegf-bispecific-fast-lane

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 ...

7. news.bms.com news.bms.com/news/corporate-financial/2025/First-Disclosure-of-Global-Interim-Phase-2-Data-for-BioNTech-and-Bristol-Myers-Squibb-PD-L1xVEGF-A-Bispecific-Antibody-Pumitamig-BNT327-BMS986545-in-Patients-with-Extensive-Stage-Small-Cell-Lung-Cancer-Shows-Encouraging-Antitumor-Activity/default.aspx

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 ...