Comparing 5 approaches for untreated, unresectable, or metastatic colorectal cancer
Official title: A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
- Phase 2
- 5 groups
- Sites in Calgary, Halifax and 4 more cities
- Recruiting
Interventions (5)
- Medication
Pumitamig
Specified dose on specified days
- Medication
FOLFOX
Specified dose on specified days
- Medication
FOLFIRI
Specified dose on specified days
- Medication
Bevacizumab
Specified dose on specified days
- Medication
CAPOX
Specified dose on specified days
Canadian Sites (8)
3 of 8 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec
- Recruiting
Jewish General Hospital
Montreal, Quebec
- Recruiting
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUS
Sherbrooke, Quebec
- Not yet recruiting
Local Institution - 0550
Calgary, Alberta
- Not yet recruiting
Local Institution - 0260
Halifax, Nova Scotia
- Not yet recruiting
Local Institution - 0255
Ottawa, Ontario
- Withdrawn
Local Institution - 0424
Toronto, Ontario
- Not yet recruiting
Local Institution - 0421
Toronto, Ontario
Eligibility Criteria
See who this study is looking for15 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used).
- +Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing.
- +Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
- +Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
- +Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
- +Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
- +Other protocolProtocolThe detailed plan a study must follow.Read more →-defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteria apply.
- +Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery.
- +Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
Exclusion
- −Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression.
- −Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence.
- −Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome.
- −Other protocolProtocolThe detailed plan a study must follow.Read more →-defined InclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more →/Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
- −Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy.
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 →/3 — a combined study that runs the middle stage and the large comparison stage together.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 5 groups in this study.
Groups A and B receive one or more of: Pumitamig, FOLFOX and FOLFIRI.
Registry label: A: Arm A1 · B: Arm A2
Group C receives one or more of: FOLFOX, FOLFIRI and Bevacizumab.
Registry label: C: Arm B
Group D receives one or more of: Pumitamig, FOLFOX, FOLFIRI and CAPOX.
Registry label: D: Arm C
Group E receives one or more of: FOLFOX, FOLFIRI, Bevacizumab and CAPOX.
Registry label: E: Arm D
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
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.
Neither you nor the study team would know which group you are in until the study ends.
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.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
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.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 990 people.
The study is currently expected to finish around March 2034.
The main measurement is taken over: Up to 5 years.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → assessment — measured over Up to 5 years.
Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) — measured over Up to 5 years.
Overall Survival (OS) — measured over Up to 5 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07221357 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 PumitamigDrug
Specified dose on specified days
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 FOLFOXDrug
Specified dose on specified days
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 FOLFIRIDrug
Specified dose on specified days
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
Specified dose on specified days
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 CAPOXDrug
Specified dose on specified days
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: a minimum age of 18 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.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
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 a minimum age of 18 years, with no upper limit given.
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.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 5 years.
The study as a whole is currently expected to finish around 2034-03-11.
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 990 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 16 locations, including: Calgary, Alberta, Canada; Halifax, Nova Scotia, Canada; Ottawa, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Sherbrooke, Quebec, Canada, and 10 more.
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 purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer
Other Sites (10)
Local Institution - 0430
Ann Arbor, Michigan, United States
Local Institution - 0254
Grand Rapids, Michigan, United States
Minnesota Oncology
Maple Grove, Minnesota, United States
Northwell Health/ RJ Zuckerberg Cancer Center
Lake Success, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Mineola, New York, United States
New York Cancer and Blood Specialists
Shirley, New York, United States
Local Institution - 0491
Edmonds, Washington, United States
Local Institution - 0253
Seattle, Washington, United States
Local Institution - 0629
Spokane, Washington, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
If this study interests you
Three things you can do from here. None of them commits you to anything.
Save it to your Collection
Keep it with the other studies you are looking at.
Share it with your doctor
Send the study to your own clinician to talk through together.
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Or answer a few questions to see which studies in Canada are closest to what you described.
This 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.