A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
CANTOR
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)
2 other identifiers
interventional
120
12 countries
76
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2025
Typical duration for phase_2
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2025
CompletedStudy Start
First participant enrolled
March 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 7, 2028
April 20, 2026
April 1, 2026
2.2 years
January 20, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS)
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.
Approximately 3 years
Number of Participants with Adverse Events (AEs)
Number of participants who received at least one dose of study treatment will be assessed.
Approximately 3 years
Secondary Outcomes (8)
Overall Survival (OS)
Approximately 3 years
Objective Response Rate (ORR)
Approximately 3 years
Disease Control Rate (DCR)
Approximately 3 years
Duration of Response (DOR)
Approximately 3 years
Time to second progression or death (PFS2)
Approximately 3 years
- +3 more secondary outcomes
Study Arms (2)
Volrustomig + FOLFIRI+ Bevacizumab group (Arm A)
EXPERIMENTALParticipants will receive FOLFIRI and bevacizumab together with volrustomig.
FOLFIRI+ BEVACIZUMAB group (Arm B)
ACTIVE COMPARATORPartcipants will receive FOLFIRI and bevacizumab.
Interventions
Volrustomig will be administered as intravenous (IV) infusion.
Bevacizumab will be administered as IV infusion.
FOLFIRI will be administered as IV infusion.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Parexelcollaborator
Study Sites (76)
Research Site
Scottsdale, Arizona, 85259, United States
Research Site
Los Angeles, California, 90089, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Baltimore, Maryland, 21224, United States
Research Site
Boston, Massachusetts, 02114, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
Trenton, New Jersey, 08690, United States
Research Site
Rochester, New York, 14618, United States
Research Site
Cleveland, Ohio, 44106, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Nashville, Tennessee, 37232, United States
Research Site
Houston, Texas, 77030, United States
Research Site
East Melbourne, 3002, Australia
Research Site
Wollongong, 2500, Australia
Research Site
Woodville South, 5011, Australia
Research Site
Victoria, British Columbia, V8R 6V5, Canada
Research Site
Barrie, Ontario, L4M 6M2, Canada
Research Site
Toronto, Ontario, M5G 1X6, Canada
Research Site
Montreal, Quebec, H3T 1E2, Canada
Research Site
Beijing, 100142, China
Research Site
Chengdu, 610041, China
Research Site
Harbin, 150081, China
Research Site
Shanghai, 200003, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 201114, China
Research Site
Wuhan, 430079, China
Research Site
Zhengzhou, 450000, China
Research Site
Bordeaux, 33076, France
Research Site
Marseille, 13273, France
Research Site
Montpellier, 34090, France
Research Site
Montpellier, 34298, France
Research Site
Poitiers, 86021, France
Research Site
Saint-Priez En Jarez, 42270, France
Research Site
Villejuif, 94805, France
Research Site
Berlin, 10117, Germany
Research Site
Dresden, 01307, Germany
Research Site
Essen, 45147, Germany
Research Site
Hamburg, 22763, Germany
Research Site
Marburg, 35043, Germany
Research Site
Bologna, 40133, Italy
Research Site
Castelfranco Veneto, 31033, Italy
Research Site
Florence, 50134, Italy
Research Site
Milan, 20133, Italy
Research Site
Milan, 20162, Italy
Research Site
Naples, 80131, Italy
Research Site
Pavia, 27100, Italy
Research Site
Pisa, 56100, Italy
Research Site
Roma, 00168, Italy
Research Site
Amsterdam, 1066 CX, Netherlands
Research Site
Maastricht, 6202 AZ, Netherlands
Research Site
Zwolle, 8025 AB, Netherlands
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 5505, South Korea
Research Site
Yongin-si, 16995, South Korea
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 8003, Spain
Research Site
Madrid, 28007, Spain
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28041, Spain
Research Site
Málaga, 29010, Spain
Research Site
Pamplona, 31005, Spain
Research Site
Santander, 39008, Spain
Research Site
Valencia, 46010, Spain
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Taipei, 10002, Taiwan
Research Site
Taoyuan District, 333, Taiwan
Research Site
Yung Kang City, 71044, Taiwan
Research Site
Cambridge, CB2 0XY, United Kingdom
Research Site
London, NW1 2PG, United Kingdom
Research Site
London, W12 0HS, United Kingdom
Research Site
Manchester, M20 4GJ, United Kingdom
Research Site
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2025
First Posted
January 27, 2025
Study Start
March 12, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
June 7, 2028
Last Updated
April 20, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure researchenvironmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes",indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.