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Looking for participantsPhase2/Phase3

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

Sponsor: Bristol-Myers Squibb

NCT ID: NCT07221357

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Pumitamig (drug), FOLFOX (drug), FOLFIRI (drug), Bevacizumab (drug)
How long the study runs
Study runs about 99 months (dates as stated)
About the drug or intervention
Pumitamig — drug: Specified dose on specified days · FOLFOX — drug: Specified dose on specified days · FOLFIRI — drug: Specified dose on specified days · Bevacizumab — drug: Specified dose on specified days · CAPOX — drug: Specified dose on specified days
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
990
Started
2025-12-31
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for untreated, unresectable, or metastatic colorectal cancer
  • • Phase2/Phase3 - 990 participants
  • • 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?

  • • Ages 18 Years and over
  • • Diagnosed with untreated, unresectable, or metastatic colorectal cancer

Where?

  • • Norwich - Norfolk and Norwich University Hospitals NHS Foundation Trust
  • • Manchester - The Christie NHS Foundation Trust
  • • Metropolitan Borough of Wirral - Local Institution - 0599
  • • Oxford - Oxford University Hospitals NHS Trust
  • • +11 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

Untreated, Unresectable, or Metastatic Colorectal Cancer

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

MSIBRAFPD-L1CD137

Treatment history

Treatments you must have had:

  • ✓ measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1

What the study is looking for

  • ✓Inclusion Criteria
  • ✓Participant must previously untreated, confirmed by a biopsy recurrent or that has spread colorectal adenocarcinoma,...
  • ✓Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high...
  • ✓Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local...
  • ✓Participant must have cancer that can be measured on scans as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
See the full criteria
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 Is This Study? (15 UK sites)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich NR47UY, United Kingdom

Recruiting
Hospital R&D contact (matched)

Julie Dawson

rdsubmissions@nnuh.nhs.uk01603 286611

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Local Institution - 0599

Metropolitan Borough of Wirral L63 4JY, United Kingdom

NOT_YET_RECRUITING

Oxford University Hospitals NHS Trust

Oxford OX3 7LJ, United Kingdom

Recruiting
Site contact (verified)
Victoria Woodcock, Site 0366+441865741841

The Royal Surrey County Hospital NHS Foundation Trust

Guildford GU27XX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Barnett

rsc-tr.ResearchAndDevelopment@nhs.net01483 688600

University Hospitals Birmingham

Birmingham B15 2TH, United Kingdom

Recruiting
Site contact (verified)
Victoria Kunene, Site 0540+441216272000

Velindre Cancer Centre

Cardiff CF14 2TL, United Kingdom

Recruiting
Hospital R&D contact (matched)

Sarah Townsend

Velindre.R&Doffice@wales.nhs.uk02920 196165

Local Institution - 0602

Dorchester DT1 2JY, United Kingdom

NOT_YET_RECRUITING

Local Institution - 0307

Glasgow G12 0YN, United Kingdom

NOT_YET_RECRUITING

Royal Free London NHS Foundation Trust

London NW32QG, United Kingdom

Recruiting
Site contact (verified)
Nikos Diamantis, Site 0600442034655501

Royal Marsden Hospital Sutton

London SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Naureen Starling, Site 0596442086426011

St. George's Hospital

London SW170QT, United Kingdom

Recruiting
Site contact (verified)
Dimitra Repana, Site 0639+442071882006

Royal Marsden Hospital

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Naureen Starling, Site 0316442086426011

Maidstone and Tunbridge Wells NHS Trust

Maidstone ME16 9QQ, United Kingdom

Recruiting
Site contact (verified)
Mark Hill, Site 0368+441622225041

Freeman Hospital

Newcastle upon Tyne NE7 7DN, United Kingdom

Recruiting

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09