Metastatic Colorectal CancerPhase 2CANTORNCT06792695
A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
A Phase 2 study testing Volrustomig, FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan) and Bevacizumab in people with Metastatic Colorectal Cancer, run by AstraZeneca at 56 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- Volrustomig, FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan) and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 56 sitesin 12 countries
- Study dates
- 12 Mar 2025to 29 Sep 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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, prior neoadjuvant/adjuvant chemotherapy is permitted only when given for resected (M0) disease and only after at least 6 months have elapsed since completion of that therapy and 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.
- History of active primary immunodeficiency.
Trial locations and contacts
56 sites in 12 countries.
56 sites in 12 countries
United States10 sites
Research Site
Baltimore, Maryland, 21224
Research Site
Boston, Massachusetts, 02114
Research Site
Houston, Texas, 77030
Research Site
Los Angeles, California, 90089
Research Site
Nashville, Tennessee, 37232
Research Site
Rochester, Minnesota, 55905
Research Site
Rochester, New York, 14618
Research Site
Scottsdale, Arizona, 85259
Research Site
Trenton, New Jersey, 08690
Research Site
Washington D.C., District of Columbia, 20007
Spain8 sites
Research Site
Barcelona, 08035
Research Site
Barcelona, 8003
Research Site
Madrid, 28034
Research Site
Madrid, 28041
Research Site
Málaga, 29010
Research Site
Pamplona, 31005
Research Site
Santander, 39008
Research Site
Valencia, 46010
Germany5 sites
Research Site
Berlin, 10117
Research Site
Dresden, 01307
Research Site
Essen, 45147
Research Site
Hamburg, 22763
Research Site
Marburg, 35043
South Korea5 sites
Research Site
Seoul, 03080
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Research Site
Seoul, 5505
Research Site
Yongin-si, 16995
United Kingdom5 sites
Research Site
Cambridge, CB2 0XY
Research Site
London, NW1 2PG
Research Site
London, W12 0HS
Research Site
Manchester, M20 4GJ
Research Site
Metropolitan Borough of Wirral, CH63 4JY
Canada4 sites
Research Site
Barrie, Ontario, L4M 6M2
Research Site
Montreal, Quebec, H3T 1E2
Research Site
Toronto, Ontario, M5G 1X6
Research Site
Victoria, British Columbia, V8R 6V5
France4 sites
Research Site
Montpellier, 34090
Research Site
Poitiers, 86021
Research Site
Saint-Priez En Jarez, 42270
Research Site
Villejuif, 94805
Italy4 sites
Research Site
Bologna, 40133
Research Site
Florence, 50134
Research Site
Milan, 20133
Research Site
Naples, 80131
Taiwan4 sites
Research Site
Kaohsiung City, 80756
Research Site
Taipei, 10002
Research Site
Taoyuan, 333
Research Site
Yung Kang City, 71044
Australia3 sites
Research Site
East Melbourne, 3002
Research Site
Wollongong, 2500
Research Site
Woodville South, 5011
Netherlands3 sites
Research Site
Amsterdam, 1066 CX
Research Site
Maastricht, 6202 AZ
Research Site
Zwolle, 8025 AB
About this study
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)
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).
Read the 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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- Volrustomig, FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan), Bevacizumab
- Keywords
- Metastatic disease, Immunotherapy, Liver metastasis, Mismatch-repair-proficient, Antibody targeting, Colorectal Cancer, CANTOR
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolrustomigDrug
Also called MEDI5752
Volrustomig will be administered as intravenous (IV) infusion.
FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)Drug
FOLFIRI will be administered as IV infusion.
BevacizumabDrug
Bevacizumab will be administered as IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Volrustomig + FOLFIRI+ Bevacizumab group (Arm A) | Experimental | Participants will receive FOLFIRI and bevacizumab together with volrustomig. Receives: Drug: Volrustomig; Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan); Drug: Bevacizumab |
| FOLFIRI+ BEVACIZUMAB group (Arm B) | Active comparator | Partcipants will receive FOLFIRI and bevacizumab. Receives: Drug: FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan); Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Approximately 3 years
Secondary outcomes (8)
Overall Survival (OS)
OS is defined as the time from randomization until the date of death due to any cause.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start12 Mar 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion29 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06792695
- Sponsor's protocol ID
- D798VC00001
- Other IDs
- 2024-518469-84-00
- Acronym
- CANTOR
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.