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New hope for colorectal cancer: experimental combo trial launches

NCT ID NCT06792695

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 19, 2026 · Updated 5 times

Summary

This phase 2 trial is testing a new immunotherapy drug called volrustomig, combined with standard chemotherapy (FOLFIRI) and bevacizumab, in 120 people with metastatic colorectal cancer. The goal is to see if the combination is safe and helps control the cancer longer. Participants must have measurable disease and no prior treatment for advanced cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Volrustomig (an experimental immunotherapy) combined with FOLFIRI chemotherapy and bevacizumab
What this could lead to
If successful, this could lead to a new treatment option that helps control metastatic colorectal cancer for longer.
What could go wrong
This is an early phase 2 trial with only 120 participants, so results may not apply to everyone. The experimental drug may cause side effects or not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Overall Inclusion Criteria: * Histopathologically confirmed colorectal adenocarcinoma. * Provision of FFPE tumor sample collected as per SoC. * Presence of measurable disease by RECIST 1.1 criteria. * ECOG performance status of 0 or 1. * Life expectancy ≥ 12 weeks at the time of screening. Substudy Inclusion Criteria: * No radiological evidence of liver metastasis. * No prior systemic therapy for mCRC, except for neoadjuvant/adjuvant chemotherapy where, \> 6 months have elapsed between completion of therapy and documented date of diagnosis of recurrent or metastatic disease. * Known pMMR/MSS status (only pMMR/MSS mCRC allowed). * Adequate organ and bone marrow function * Body weight \> 35 kg at screening and at randomization. * Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Overall Exclusion Criteria: * Central nervous system metastases or spinal cord compression * Known history of severe allergy to any monoclonal antibody or study intervention. * Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy. * History of another primary malignancy. Substudy Exclusion Criteria: * Potentially resectable disease with multidisciplinary plan for radical surgery. * Active or prior documented autoimmune or inflammatory disorders or cardiac conditions. * Participants with a prior history of hypertensive crisis or hypertensive encephalopathy or bleeding risks. * Deep venous thrombosis, pulmonary embolism, arterial thrombosis, transient ischemic attack or cerebrovascular accident. * History of abdominal or tracheoesophageal fistula, GI perforation and/or fistulae, or intraabdominal abscess within 6 months prior to randomization. * Prior exposure to immune mediated therapy.

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma colorectal cancer colorectal neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic colorectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    72 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Research Site

    RECRUITING

    Los Angeles, California, 90089, United States

  • Research Site

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Research Site

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • Research Site

    RECRUITING

    Baltimore, Maryland, 21224, United States

  • Research Site

    COMPLETED

    Boston, Massachusetts, 02114, United States

  • Research Site

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Research Site

    RECRUITING

    Trenton, New Jersey, 08690, United States

  • Research Site

    RECRUITING

    Rochester, New York, 14618, United States

  • Research Site

    WITHDRAWN

    Cleveland, Ohio, 44106, United States

  • Research Site

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Research Site

    WITHDRAWN

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    NOT_YET_RECRUITING

    Nashville, Tennessee, 37232, United States

  • Research Site

    RECRUITING

    Houston, Texas, 77030, United States

  • Research Site

    RECRUITING

    East Melbourne, 3002, Australia

  • Research Site

    RECRUITING

    Wollongong, 2500, Australia

  • Research Site

    RECRUITING

    Woodville South, 5011, Australia

  • Research Site

    RECRUITING

    Victoria, British Columbia, V8R 6V5, Canada

  • Research Site

    RECRUITING

    Barrie, Ontario, L4M 6M2, Canada

  • Research Site

    RECRUITING

    Toronto, Ontario, M5G 1X6, Canada

  • Research Site

    RECRUITING

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    NOT_YET_RECRUITING

    Beijing, 100142, China

  • Research Site

    SUSPENDED

    Chengdu, 610041, China

  • Research Site

    NOT_YET_RECRUITING

    Harbin, 150081, China

  • Research Site

    NOT_YET_RECRUITING

    Shanghai, 200003, China

  • Research Site

    SUSPENDED

    Shanghai, 200032, China

  • Research Site

    NOT_YET_RECRUITING

    Shanghai, 201114, China

  • Research Site

    SUSPENDED

    Wuhan, 430079, China

  • Research Site

    SUSPENDED

    Zhengzhou, 450000, China

  • Research Site

    SUSPENDED

    Bordeaux, 33076, France

  • Research Site

    WITHDRAWN

    Marseille, 13273, France

  • Research Site

    RECRUITING

    Montpellier, 34090, France

  • Research Site

    SUSPENDED

    Montpellier, 34298, France

  • Research Site

    RECRUITING

    Poitiers, 86021, France

  • Research Site

    RECRUITING

    Saint-Priez En Jarez, 42270, France

  • Research Site

    RECRUITING

    Villejuif, 94805, France

  • Research Site

    RECRUITING

    Berlin, 10117, Germany

  • Research Site

    RECRUITING

    Dresden, 01307, Germany

  • Research Site

    RECRUITING

    Essen, 45147, Germany

  • Research Site

    RECRUITING

    Hamburg, 22763, Germany

  • Research Site

    RECRUITING

    Marburg, 35043, Germany

  • Research Site

    RECRUITING

    Bologna, 40133, Italy

  • Research Site

    SUSPENDED

    Castelfranco Veneto, 31033, Italy

  • Research Site

    RECRUITING

    Florence, 50134, Italy

  • Research Site

    RECRUITING

    Milan, 20133, Italy

  • Research Site

    SUSPENDED

    Milan, 20162, Italy

  • Research Site

    RECRUITING

    Naples, 80131, Italy

  • Research Site

    SUSPENDED

    Pavia, 27100, Italy

  • Research Site

    SUSPENDED

    Pisa, 56100, Italy

  • Research Site

    SUSPENDED

    Roma, 00168, Italy

  • Research Site

    RECRUITING

    Amsterdam, 1066 CX, Netherlands

  • Research Site

    RECRUITING

    Maastricht, 6202 AZ, Netherlands

  • Research Site

    RECRUITING

    Zwolle, 8025 AB, Netherlands

  • Research Site

    RECRUITING

    Seoul, 03080, South Korea

  • Research Site

    RECRUITING

    Seoul, 06351, South Korea

  • Research Site

    RECRUITING

    Seoul, 06591, South Korea

  • Research Site

    RECRUITING

    Seoul, 5505, South Korea

  • Research Site

    RECRUITING

    Yongin-si, 16995, South Korea

  • Research Site

    RECRUITING

    Barcelona, 08035, Spain

  • Research Site

    RECRUITING

    Barcelona, 8003, Spain

  • Research Site

    SUSPENDED

    Madrid, 28007, Spain

  • Research Site

    RECRUITING

    Madrid, 28034, Spain

  • Research Site

    RECRUITING

    Madrid, 28041, Spain

  • Research Site

    RECRUITING

    Málaga, 29010, Spain

  • Research Site

    RECRUITING

    Pamplona, 31005, Spain

  • Research Site

    RECRUITING

    Santander, 39008, Spain

  • Research Site

    RECRUITING

    Valencia, 46010, Spain

  • Research Site

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Research Site

    RECRUITING

    Taipei, 10002, Taiwan

  • Research Site

    RECRUITING

    Taoyuan, 333, Taiwan

  • Research Site

    RECRUITING

    Yung Kang City, 71044, Taiwan

  • Research Site

    RECRUITING

    Cambridge, CB2 0XY, United Kingdom

  • Research Site

    RECRUITING

    London, NW1 2PG, United Kingdom

  • Research Site

    RECRUITING

    London, W12 0HS, United Kingdom

  • Research Site

    RECRUITING

    Manchester, M20 4GJ, United Kingdom

  • Research Site

    RECRUITING

    Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

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