Comparing Volrustomig with FOLFIRI (Fluorouracil (5-FU), for metastatic colorectal cancer
Official title: A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
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)
Interventions
Volrustomig
Volrustomig will be administered as intravenous (IV) infusion.
FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)
FOLFIRI will be administered as IV infusion.
Bevacizumab
Bevacizumab will be administered as IV infusion.
Canadian Sites (4)
Research Site
Victoria, British Columbia, Canada
Research Site
Barrie, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for23 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Histopathologically confirmed colorectal adenocarcinoma.
- +Provision of FFPE tumor sample collected as per SoCStandard of careThe treatment normally given for a condition outside a study.Read more →.
- +Presence of measurable disease by RECIST 1.1 criteria.
- +Life expectancy ≥ 12 weeks at the time of screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
- +Substudy Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
- +No radiological evidence of liver metastasis.
- +Known pMMR/MSS status (only pMMR/MSS mCRC allowed).
- +Adequate organ and bone marrow function
- +Body weight \> 35 kg at screening and at randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- +ECOG performance status of 0 or 1.
- +Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- +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.
Exclusion
- −Known history of severe allergy to any monoclonal antibody or study intervention.
- −Central nervous system metastases or spinal cord compression
- −Any unresolved toxicity CTCAE Grade ≥ 2 from a previous anticancer therapy.
- −History of another primary malignancy.
- −Substudy Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
- −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 randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
- −Prior exposure to immune mediated therapy.
- −Potentially resectable disease with multidisciplinary plan for radical surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Volrustomig, FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan), Bevacizumab.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 130 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 80 people.
The study is currently expected to finish around September 2028.
The main measurement is taken over: Approximately 3 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Progression Free Survival (PFS) — measured over Approximately 3 years.
Number of Participants with Adverse EventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (AEs) — measured over Approximately 3 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06792695 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About VolrustomigDrug
Volrustomig will be administered as intravenous (IV) infusion.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About FOLFIRI (Fluorouracil (5-FU), leucovorin, irinotecan)Drug
FOLFIRI will be administered as IV infusion.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About BevacizumabDrug
Bevacizumab will be administered as IV infusion.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 130 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 130 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Approximately 3 years.
The study as a whole is currently expected to finish around 2028-09-29.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 80 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 6 locations, including: Victoria, British Columbia, Canada; Barrie, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Rochester, Minnesota, United States; Rochester, New York, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Other Sites (2)
Research Site
Rochester, Minnesota, United States
Research Site
Rochester, New York, United States
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.