Comparing PF-08634404 with Bevacizumab for intestinal neoplasms
Official title: Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer
AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER
- Phase 3
- 2 groups
- Sites in Toronto and Montreal
- Recruiting
Interventions
- Medication
PF-08634404
Solution for infusion
- Biological therapy
Bevacizumab
Injection for intravenous use
- Medication
Chemotherapy
Injection for intravenous use
Canadian Sites (4)
4 of 4 recruiting
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
- Recruiting
Jewish General Hospital
Montreal, Quebec
- Recruiting
McGill University Health Centre
Montreal, Quebec
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Eastern Cooperative Oncology Group performance status (ECOG) 0-1
- +Histological or cytological confirmed colorectal adenocarcinoma.
- +Evidence of Stage IV metastatic disease.
- +No prior systemic therapy for metastatic disease.
- +At least one measurable lesion according to RECIST 1.1 per InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → assessment.
- +Adequate hepatic, liver, and renal function
Exclusion
- −Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
- −Participants are excluded from the study if any of the following criteria apply:
- −Locally confirmed BRAF V600E mutation
- −Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer
- −Clinically significant risk of hemorrhage or fistula
- −History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
- −Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
- −Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
- −Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
- −Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis
- −Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
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 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives PF-08634404 and Chemotherapy.
Registry label: A: PF-08634404 + Chemotherapy
Group B, the comparison group, receives Bevacizumab and Chemotherapy.
Registry label: B: Bevacizumab + Chemotherapy
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.
One group receives an existing treatment, so the two can be compared.
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 800 people.
The study is currently expected to finish around August 2031.
The main measurement is taken over: Approximately 4 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) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR) — measured over Approximately 4 years.
Overall survival (OS) — measured over Approximately 4 years.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07222800 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 PF-08634404Drug
Solution for 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 BevacizumabBiological
Injection for intravenous use
From the trial registry — its own words, unedited.
What a biological is here: A treatment made from or by living systems — such as antibodies, vaccines, or cell-based therapies.
Read the full explanation → · in clinical review
About ChemotherapyDrug
Injection for intravenous use
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.
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?
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: Approximately 4 years.
The study as a whole is currently expected to finish around 2031-08-01.
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 800 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 29 locations, including: Toronto, Ontario, Canada; Montreal, Quebec, Canada; Big Rapids, Michigan, United States; Grand Rapids, Michigan, United States; Holland, Michigan, United States; Norton Shores, Michigan, United States, and 23 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 learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have colorectal cancer that has spread to other parts of your body. * Be in good enough health to receive study treatment. * Should not be pregnant before starting treatment. Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects. The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment. * The study is expected to last approximately 33 months for each participant. * Participants will have regular visits to the study site for treatment, health checks, and tests. * After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects. * Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.
Other Sites (34)
The Cancer & Hematology Centers
Big Rapids, Michigan, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
The Cancer & Hematology Centers
Grand Rapids, Michigan, United States
The Cancer & Hematology Centers
Holland, Michigan, United States
The Cancer & Hematology Centers
Norton Shores, Michigan, United States
Avera Cancer Institute- Marshall
Marshall, Minnesota, United States
Mayo Clinic Hospital, Methodist Campus, Research Pharmacy
Rochester, Minnesota, United States
Mayo Clinic Pharmacy
Rochester, Minnesota, United States
Mayo Clinic Cancer Center Outpatient Pharmacy
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Rochester Methodist Clinical Research Unit
Rochester, Minnesota, United States
St. Marys Campus
Rochester, Minnesota, United States
NYOH Albany Cancer Center
Albany, New York, United States
Hematology-Oncology Associates of Central New York, PC
Auburn, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Babylon, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
Brooklyn, New York, United States
Hematology-Oncology Associates of Central New York, PC
Camillus, New York, United States
New York Oncology Hematology - Clifton Park Cancer Center
Clifton Park, New York, United States
Hematology-Oncology Associates of Central New York, PC
East Syracuse, New York, United States
North Shore Hematology Oncology Associates P.C. DBA New York Cancer and Blood Specialists
New Hyde Park, New York, United States
And 14 more sites worldwide.
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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.