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A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
NCT06792695 · AstraZeneca
In plain English
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Official 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)
About this study
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 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.
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-03-12
Estimated completion: 2028-06-07
Last updated: 2026-05-11
Interventions
Drug: VolrustomigDrug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)Drug: Bevacizumab
Primary outcomes
- • Progression Free Survival (PFS) (Approximately 3 years)
- • Number of Participants with Adverse Events (AEs) (Approximately 3 years)
Sponsor
AstraZeneca · industry
With: Parexel
Contacts & investigators
ContactAstraZeneca Clinical Study Information Center · contact · information.center@astrazeneca.com · 1-877-240-9479
All locations (76)
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Scottsdale, Arizona, United States
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Los Angeles, California, United States
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Washington D.C., District of Columbia, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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Rochester, Minnesota, United States
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Trenton, New Jersey, United States
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Rochester, New York, United States
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Cleveland, Ohio, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Nashville, Tennessee, United States
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Houston, Texas, United States
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East Melbourne, Australia
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Wollongong, Australia
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Woodville South, Australia
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Victoria, British Columbia, Canada
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Barrie, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Beijing, China
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Chengdu, China
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Harbin, China
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Shanghai, China
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Shanghai, China
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Shanghai, China
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Wuhan, China
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Zhengzhou, China
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Bordeaux, France
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Marseille, France
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Montpellier, France
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Montpellier, France
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Poitiers, France
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Saint-Priez En Jarez, France
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Villejuif, France
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Berlin, Germany
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Dresden, Germany
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Essen, Germany
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Hamburg, Germany
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Marburg, Germany
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Bologna, Italy
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Castelfranco Veneto, Italy
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Florence, Italy
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Milan, Italy
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Milan, Italy
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Naples, Italy
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Pavia, Italy
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Pisa, Italy
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Roma, Italy
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Amsterdam, Netherlands
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Maastricht, Netherlands
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Zwolle, Netherlands
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Seoul, South Korea
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Yongin-si, South Korea
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Barcelona, Spain
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Barcelona, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Málaga, Spain
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Pamplona, Spain
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Santander, Spain
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Valencia, Spain
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Kaohsiung City, Taiwan
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Taipei, Taiwan
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Taoyuan, Taiwan
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Yung Kang City, Taiwan
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Cambridge, United Kingdom
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London, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Metropolitan Borough of Wirral, United Kingdom