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A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Study of Novel Study Interventions and Combinations in Participants With 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)

NCT06792695•AstraZeneca

View on ClinicalTrials.gov

Summary

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).

Detailed Description

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.

Eligibility

Age

18 - 130 years

Sex

ALL

Healthy Volunteers

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.
•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.
+1 more criteria

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.
•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.

Locations (76)

Research Site

Scottsdale, Arizona, United States

Research Site

Los Angeles, California, United States

Research Site

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

Research Site

Chicago, Illinois, United States

Research Site

Baltimore, Maryland, United States

Research Site

Boston, Massachusetts, United States

Research Site

Rochester, Minnesota, United States

Research Site

Trenton, New Jersey, United States

Research Site

Rochester, New York, United States

Research Site

Cleveland, Ohio, United States

Key Dates

Start Date

March 12, 2025

Primary Completion Date

May 31, 2027

Completion Date

June 7, 2028

Last Updated

January 20, 2026

Enrollment

120

ESTIMATED participants

Conditions

Metastatic Colorectal Cancer

Interventions

Volrustomig

DRUG

FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)

DRUG

Bevacizumab

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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