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RecruitingLast updated: 16 February 2026

CANTOR: A study recruiting people with colorectal cancer (CRC) to evaluate how safe and effective new medicines and combinations of medicines areA Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Bowel Cancers Lower gastrointestinal tract

Age

People18 - 130

Trial acronym

CANTOR

Clinical summary

Summary

This is a modular study, that includes a master protocol and substudies.

Participants will be randomly assigned (by chance) to one of the following treatment intervention groups:

  • Volrustomig immunotherapy + FOLFIRI chemotherapy + bevacizumab targeted therapy group (Arm A)
  • FOLFIRI chemotherapy + bevacizumab targeted therapy 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 people with mismatch-repair proficient (pMMR)/Microsatellite stable (MSS) metastatic CRC (mCRC) in the absence of liver metastases and who have not received prior systemic treatment for advanced or metastatic disease.

The eligibility criteria for the overall study and the substudy differ slightly, so please speak to your doctor about whether you are eligible.

Conditions

This trial is treating people with bowel cancer (colorectal cancer)

Eligibility

Inclusion

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.

Exclusion

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.

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific Title

A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)

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