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Study of Volrustomig for Metastatic Colorectal Cancer

This study is looking at new ways to treat metastatic colorectal cancer (cancer that has spread). It tests a drug called Volrustomig in combination with standard treatments, FOLFIRI (a chemotherapy combination of Fluorouracil, leucovorin, and irinotecan) and Bevacizumab. You might be eligible if you have colorectal adenocarcinoma that has spread, meet certain health criteria like an ECOG performance status of 0 or 1, and have a life expectancy of at least 12 weeks. The study will measure how long people live without their cancer getting worse (Progression Free Survival) and track any side effects over about 3 years. This study is currently unclear on its recruitment status and plans to enroll 80 participants.

Study design
This is a Phase II, open-label study, meaning you and your doctors will know which treatment you are receiving. It is a multi-drug, multicenter study that will randomly assign participants to one of two treatment groups.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will follow participants for approximately 3 years to measure Progression Free Survival and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06792695

A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~80 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:VolrustomigFOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)Bevacizumab

At a glance

Recruiting sites
53 of 76 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over Approximately 3 years
+1 more outcome measured

Conditions

Metastatic Colorectal Cancer

Explore related trials

Colorectal CarcinomaMRC1 wt Allele

Where it's being run

76 sites across 27 states
Italy9
Spain9
China8
France7
Germany5
South Korea5
United Kingdom5
Taiwan4

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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.
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.

What this trial measures

  • Progression Free Survival (PFS)Approximately 3 years

    PFS is defined as the time from randomization until progression per Response Evaluation Criteria in Solid Tumours, Version 1.1 (RECIST 1.1) or death due to any cause.

  • Number of Participants with Adverse Events (AEs)Approximately 3 years

    Number of participants who received at least one dose of study treatment will be assessed.