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Looking for participantsPhase2

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

Sponsor: AstraZeneca

NCT ID: NCT06792695

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
Volrustomig (drug), FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan) (drug), Bevacizumab (drug)
How long the study runs
Study runs about 42 months (dates as stated)
About the drug or intervention
Volrustomig — drug: Volrustomig will be administered as intravenous (IV) infusion. · FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan) — drug: FOLFIRI will be administered as IV infusion. · Bevacizumab — drug: Bevacizumab will be administered as IV infusion.
Patient visit burden
Not specified by the sponsor

In plain English

This AstraZeneca study is testing new study treatments, used alone or in combination, in people with metastatic colorectal cancer (bowel cancer that has spread). It is for people whose cancer is a type called pMMR/MSS. The exact treatments being studied are not stated in the registry data.

Who can take part

  • Bowel cancer confirmed by examining tissue under a microscope (colorectal adenocarcinoma)
  • A stored tumour tissue sample (FFPE) provided as part of standard care
  • Cancer that can be measured on scans using RECIST 1.1 criteria
  • Able to carry out normal daily activity with little or no restriction (ECOG performance status of 0 or 1)
  • Expected to live at least 12 weeks
  • No evidence of cancer spread to the liver on scans (for the substudy)
  • No previous whole-body drug treatment for advanced bowel cancer, unless it was given before or after surgery and finished more than 6 months before the advanced cancer was diagnosed (for the substudy)
  • Cancer known to be pMMR/MSS type (for the substudy)
  • Healthy enough organs and bone marrow (for the substudy)
  • Body weight over 35 kg (for the substudy)
  • Using contraception in line with local rules for people in clinical studies

Who may not be able to

  • Cancer that has spread to the brain or spinal cord, or pressure on the spinal cord
  • Severe allergic reaction in the past to any monoclonal antibody or study treatment
  • Ongoing side effects from previous cancer treatment rated Grade 2 or worse (CTCAE scale)
  • History of another separate cancer
  • Disease that could be removed with surgery planned by the medical team (for the substudy)
  • Current or past autoimmune or inflammatory conditions, or certain heart conditions (for the substudy)
  • Past severe high blood pressure crises or bleeding risks (for the substudy)
  • Blood clots such as deep vein thrombosis, pulmonary embolism, arterial thrombosis, mini-stroke or stroke (for the substudy)
  • Hole, abnormal connection or abscess in the stomach, gut or windpipe area within 6 months before joining (for the substudy)
  • Previous treatment with immunotherapy-type medicines (for the substudy)

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Not stated — ask the trial team about how long the study lasts, how many visits are needed, and what taking part would involve.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 130 Years
Who
All
Number of participants
80
Started
2025-03-12
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for metastatic colorectal cancer
  • • Phase2 - 80 participants
  • • The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC)

Who can take part?

  • • Ages 18 Years to 130 Years
  • • Diagnosed with metastatic colorectal cancer

Where?

  • • Cambridge - Research Site
  • • London - Research Site
  • • London - Research Site
  • • Manchester - Research Site
  • • +1 more UK sites

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

About This Trial

The main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).

More detail

This is a Phase II, platform, open-label, multi-drug, multicenter, global study. This is a modular study, that includes a master protocol and substudies. Partcipants will be randomised to one of the following intervention groups: * Volrustomig + FOLFIRI + bevacizumab group (Arm A) * FOLFIRI + bevacizumab group (Arm B) The substudy will evaluate the effects of volrustomig in combination with FOLFIRI (irinotecan, 5-FU, and leucovorin) and bevacizumab versus FOLFIRI and bevacizumab only in participants with Mismatch-repair-proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received previous systemic treatment for advanced or metastatic disease.

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 - 130 Years
  • Who can join: All genders
  • How fit you need to be: ECOG 0 or better

What the study is looking for

  • ✓Histopathologically confirmed colorectal adenocarcinoma.
  • ✓Provision of FFPE tumor sample collected as per SoC.
  • ✓Presence of cancer that can be measured on scans by (standard scan measurements) criteria.
  • ✓Fit enough for normal activity (ECOG 0) or 1.
  • ✓Life expectancy ≥ 12 weeks at the time of screening.

Who cannot take part

  • ✗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 cancer.
  • ✗Substudy Exclusion Criteria:
See the full criteria
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.

Where Is This Study? (5 UK sites)

Research Site

Cambridge CB2 0XY, United Kingdom

Recruiting

Research Site

London NW1 2PG, United Kingdom

Recruiting

Research Site

London W12 0HS, United Kingdom

Recruiting

Research Site

Manchester M20 4GJ, United Kingdom

Recruiting

Research Site

Metropolitan Borough of Wirral CH63 4JY, United Kingdom

Recruiting

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08