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)

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).

Study Overview

• Status: Recruiting
• Conditions: Metastatic Colorectal Cancer
• Intervention / Treatment: Drug: Volrustomig; Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan); Drug: Bevacizumab

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Australia
  • East Melbourne, Australia, 3002
    • Recruiting
    • Research Site
  • Wollongong, Australia, 2500
    • Recruiting
    • Research Site
  • Woodville South, Australia, 5011
    • Recruiting
    • Research Site
• Canada
  • British Columbia
    • Victoria, British Columbia, Canada, V8R 6V5
      • Recruiting
      • Research Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 6M2
      • Recruiting
      • Research Site
    • Toronto, Ontario, Canada, M5G 1X6
      • Recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H3T 1E2
      • Recruiting
      • Research Site
• China
  • Beijing, China, 100142
    • Not yet recruiting
    • Research Site
  • Chengdu, China, 610041
    • Suspended
    • Research Site
  • Harbin, China, 150081
    • Not yet recruiting
    • Research Site
  • Shanghai, China, 201114
    • Not yet recruiting
    • Research Site
  • Shanghai, China, 200032
    • Suspended
    • Research Site
  • Shanghai, China, 200003
    • Not yet recruiting
    • Research Site
  • Wuhan, China, 430079
    • Suspended
    • Research Site
  • Zhengzhou, China, 450000
    • Suspended
    • Research Site
• France
  • Bordeaux, France, 33076
    • Not yet recruiting
    • Research Site
  • Marseille, France, 13273
    • Withdrawn
    • Research Site
  • Montpellier, France, 34298
    • Not yet recruiting
    • Research Site
  • Montpellier, France, 34090
    • Not yet recruiting
    • Research Site
  • Poitiers, France, 86021
    • Recruiting
    • Research Site
  • Saint-Priez En Jarez, France, 42270
    • Recruiting
    • Research Site
  • Villejuif, France, 94805
    • Recruiting
    • Research Site
• Germany
  • Berlin, Germany, 10117
    • Not yet recruiting
    • Research Site
  • Dresden, Germany, 01307
    • Recruiting
    • Research Site
  • Essen, Germany, 45147
    • Recruiting
    • Research Site
  • Hamburg, Germany, 22763
    • Recruiting
    • Research Site
  • Marburg, Germany, 35043
    • Recruiting
    • Research Site
• Italy
  • Bologna, Italy, 40133
    • Recruiting
    • Research Site
  • Castelfranco Veneto, Italy, 31033
    • Not yet recruiting
    • Research Site
  • Florence, Italy, 50134
    • Recruiting
    • Research Site
  • Milan, Italy, 20133
    • Not yet recruiting
    • Research Site
  • Milan, Italy, 20162
    • Not yet recruiting
    • Research Site
  • Naples, Italy, 80131
    • Not yet recruiting
    • Research Site
  • Pavia, Italy, 27100
    • Not yet recruiting
    • Research Site
  • Pisa, Italy, 56100
    • Not yet recruiting
    • Research Site
  • Roma, Italy, 00168
    • Not yet recruiting
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1066 CX
    • Recruiting
    • Research Site
  • Maastricht, Netherlands, 6202 AZ
    • Recruiting
    • Research Site
  • Zwolle, Netherlands, 8025 AB
    • Recruiting
    • Research Site
• South Korea
  • Seoul, South Korea, 03080
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06351
    • Recruiting
    • Research Site
  • Seoul, South Korea, 5505
    • Recruiting
    • Research Site
  • Seoul, South Korea, 06591
    • Recruiting
    • Research Site
  • Yongin-si, South Korea, 16995
    • Recruiting
    • Research Site
• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Research Site
  • Barcelona, Spain, 8003
    • Recruiting
    • Research Site
  • Madrid, Spain, 28007
    • Not yet recruiting
    • Research Site
  • Madrid, Spain, 28034
    • Recruiting
    • Research Site
  • Madrid, Spain, 28041
    • Recruiting
    • Research Site
  • Málaga, Spain, 29010
    • Recruiting
    • Research Site
  • Pamplona, Spain, 31005
    • Recruiting
    • Research Site
  • Santander, Spain, 39008
    • Recruiting
    • Research Site
  • Valencia, Spain, 46010
    • Recruiting
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 10002
    • Recruiting
    • Research Site
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Research Site
  • Yung Kang City, Taiwan, 71044
    • Recruiting
    • Research Site
• United Kingdom
  • Cambridge, United Kingdom, CB2 0XY
    • Recruiting
    • Research Site
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • Research Site
  • London, United Kingdom, W12 0HS
    • Recruiting
    • Research Site
  • Manchester, United Kingdom, M20 4GJ
    • Recruiting
    • Research Site
  • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    • Recruiting
    • Research Site
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Recruiting
      • Research Site
  • California
    • Los Angeles, California, United States, 90089
      • Recruiting
      • Research Site
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • Not yet recruiting
      • Research Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Not yet recruiting
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Recruiting
      • Research Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Completed
      • Research Site
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Research Site
  • New Jersey
    • Trenton, New Jersey, United States, 08690
      • Not yet recruiting
      • Research Site
  • New York
    • Rochester, New York, United States, 14618
      • Recruiting
      • Research Site
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Withdrawn
      • Research Site
  • Oregon
    • Portland, Oregon, United States, 97239
      • Not yet recruiting
      • Research Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Withdrawn
      • Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Not yet recruiting
      • Research Site
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volrustomig + FOLFIRI+ Bevacizumab group (Arm A); Participants will receive FOLFIRI and bevacizumab together with volrustomig.	Drug: Volrustomig; Volrustomig will be administered as intravenous (IV) infusion.; Other Names: MEDI5752; Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan); FOLFIRI will be administered as IV infusion.; Drug: Bevacizumab; Bevacizumab will be administered as IV infusion.
Active Comparator: FOLFIRI+ BEVACIZUMAB group (Arm B); Partcipants will receive FOLFIRI and bevacizumab.	Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan); FOLFIRI will be administered as IV infusion.; Drug: Bevacizumab; Bevacizumab will be administered as IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization until the date of death due to any cause.	Approximately 3 years
Objective Response Rate (ORR)	ORR is defined as the proportion of participants who have a confirmed complete response or confirmed partial response as per RECIST 1.1.	Approximately 3 years
Disease Control Rate (DCR)	DCR is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1 after randomization.	Approximately 3 years
Duration of Response (DOR)	DoR is defined as the time from the date of first documented confirmed response until date of documented progression per RECIST 1.1 or death due to any cause.	Approximately 3 years
Time to second progression or death (PFS2)	PFS2 is defined as the time from randomization to the earliest of the progression event, after first subsequent therapy, or death.	Approximately 3 years
Maximum Observed Concentration (Cmax)	Concentration of novel study intervention in serum and PK parameters as data allow (such as peak and trough concentrations) will be assessed.	Approximately 3 years
Observed lowest concentration before the next dose is administered (Ctrough)	Concentration of novel study intervention in serum and PK parameters as data allow (such as peak and trough concentrations) will be assessed.	Approximately 3 years
Number of patients with positive Antidrug Antibodies (ADAs)	The immunogenicity (ADAs) of novel study intervention in participants with CRC in the absence of liver metastases is investigated.	Approximately 3 years

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): June 7, 2028

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Immunotherapy; Colorectal Cancer; Metastatic disease; Liver metastasis; Mismatch-repair-proficient; Antibody targeting; CANTOR
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Neoplasm Metastasis; Amino Acids, Peptides, and Proteins; Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Camptothecin; Alkaloids; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Pyrimidines; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Uracil; Pyrimidinones; Coenzymes; Bevacizumab; Irinotecan; Fluorouracil; Leucovorin
• Other Study ID Numbers: D798VC00001; 2024-518469-84 (Registry Identifier: EU (CTIS))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No