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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06792695




Registration number
NCT06792695
Ethics application status
Date submitted
20/01/2025
Date registered
25/03/2025

Titles & IDs
Public title
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
Scientific 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)
Secondary ID [1] 0 0
2024-518469-84
Secondary ID [2] 0 0
D798VC00001
Universal Trial Number (UTN)
Trial acronym
CANTOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Volrustomig
Treatment: Drugs - FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
Treatment: Drugs - Bevacizumab

Experimental: Volrustomig + FOLFIRI+ Bevacizumab group (Arm A) - Participants will receive FOLFIRI and bevacizumab together with volrustomig.

Active comparator: FOLFIRI+ BEVACIZUMAB group (Arm B) - Partcipants will receive FOLFIRI and bevacizumab.


Treatment: Drugs: Volrustomig
Volrustomig will be administered as intravenous (IV) infusion.

Treatment: Drugs: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
FOLFIRI will be administered as IV infusion.

Treatment: Drugs: Bevacizumab
Bevacizumab will be administered as IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival (PFS)
Timepoint [1] 0 0
Approximately 3 years
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AEs)
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Approximately 3 years
Secondary outcome [4] 0 0
Duration of Response (DOR)
Timepoint [4] 0 0
Approximately 3 years
Secondary outcome [5] 0 0
Time to second progression or death (PFS2)
Timepoint [5] 0 0
Approximately 3 years
Secondary outcome [6] 0 0
Maximum Observed Concentration (Cmax)
Timepoint [6] 0 0
Approximately 3 years
Secondary outcome [7] 0 0
Observed lowest concentration before the next dose is administered (Ctrough)
Timepoint [7] 0 0
Approximately 3 years
Secondary outcome [8] 0 0
Number of patients with positive Antidrug Antibodies (ADAs)
Timepoint [8] 0 0
Approximately 3 years

Eligibility
Key inclusion criteria
Overall

* 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

* 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
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

* 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
12/01/2028
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - East Melbourne
Recruitment hospital [2] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
British Columbia
Country [12] 0 0
Canada
State/province [12] 0 0
Ontario
Country [13] 0 0
Canada
State/province [13] 0 0
Quebec
Country [14] 0 0
China
State/province [14] 0 0
Beijing
Country [15] 0 0
China
State/province [15] 0 0
Harbin
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
China
State/province [17] 0 0
Zhengzhou City
Country [18] 0 0
France
State/province [18] 0 0
Bordeaux
Country [19] 0 0
France
State/province [19] 0 0
Montpellier
Country [20] 0 0
France
State/province [20] 0 0
Poitiers
Country [21] 0 0
France
State/province [21] 0 0
Saint-Priez En Jarez
Country [22] 0 0
France
State/province [22] 0 0
Villejuif Cedex
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Dresden
Country [25] 0 0
Germany
State/province [25] 0 0
Essen
Country [26] 0 0
Germany
State/province [26] 0 0
Hamburg
Country [27] 0 0
Germany
State/province [27] 0 0
Marburg
Country [28] 0 0
Italy
State/province [28] 0 0
Firenze
Country [29] 0 0
Italy
State/province [29] 0 0
Milano
Country [30] 0 0
Italy
State/province [30] 0 0
Napoli
Country [31] 0 0
Italy
State/province [31] 0 0
Pavia
Country [32] 0 0
Italy
State/province [32] 0 0
Roma
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Yongin-si
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
Malaga
Country [38] 0 0
Spain
State/province [38] 0 0
Pamplona
Country [39] 0 0
Spain
State/province [39] 0 0
Santander
Country [40] 0 0
Spain
State/province [40] 0 0
València
Country [41] 0 0
Taiwan
State/province [41] 0 0
Kaohsiung
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taoyuan
Country [44] 0 0
Taiwan
State/province [44] 0 0
Yung Kang City
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Cambridge
Country [46] 0 0
United Kingdom
State/province [46] 0 0
London
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Manchester
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06792695