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Evaluating new treatments for metastatic colorectal cancer

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)

Phase 2 Interventional AstraZeneca · NCT06792695

This study is testing a new combination of treatments for people with advanced colorectal cancer to see if it works better than the standard treatment.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years to 130 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, bevacizumab
Locations76 sites (Scottsdale, Arizona and 75 other locations)
Trial IDNCT06792695 on ClinicalTrials.gov

What this trial studies

This Phase II, open-label, multi-drug, multicenter study aims to assess the safety and efficacy of novel interventions and combinations in patients with metastatic colorectal cancer. Participants will be randomized into two groups: one receiving a combination of volrustomig, FOLFIRI, and bevacizumab, and the other receiving FOLFIRI and bevacizumab alone. The study specifically targets patients with mismatch-repair-proficient and microsatellite stable metastatic colorectal cancer without liver metastases and who have not undergone prior systemic treatment for advanced disease.

Who should consider this trial

Good fit: Ideal candidates are adults with histologically confirmed colorectal adenocarcinoma, measurable disease, and specific genetic markers (pMMR/MSS) without liver metastases.

Not a fit: Patients with central nervous system metastases or those who have received prior systemic therapy for metastatic colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with metastatic colorectal cancer.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches in colorectal cancer, indicating potential for success in this novel combination.

Eligibility criteria

Show full inclusion / exclusion 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 this trial is running

Scottsdale, Arizona and 75 other locations

+26 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Colorectal CancerMetastatic diseaseImmunotherapyLiver metastasisMismatch-repair-proficientAntibody targetingColorectal CancerCANTOR
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.