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NCT05217446 · ClinicalTrials.gov registry record · Phase 2
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
A Phase 2 study of Metastatic Colorectal Cancer, sponsored by Pfizer.
- Active
- Registry status
- Phase 2
- Development phase
- 107
- Enrollment target
- 20
- Study locations
NCT05217446: Active Phase 2 study of Metastatic Colorectal Cancer, sponsored by Pfizer.
NCT05217446 is a Phase 2 study of Metastatic Colorectal Cancer that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 107 participants, below the 184-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (42% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05217446, a Phase 2 study of Metastatic Colorectal Cancer, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 107 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to mutation) or impaired DNA mismatch repair (MMR) * has a certain type of abnormal gene called "BRAF" and; * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic as an intravenous (IV) infusion (given directly into a vein) at the study clinic. In addition, half of the participants will take encorafenib by mouth at home every day and cetuximab by IV infusion at the study clinic. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Primary Outcome
PFS per investigator, defined as the time from randomization until PD based on investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause, whichever occurs first:
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Cetuximab
- DRUG Encorafenib
Study Locations (20)
Arizona
- Mayo Clinic Building - Phoenix - Phoenix
- Mayo Clinic Hospital - Phoenix
- Mayo Clinic - Scottsdale
Victoria
- Austin Health - Heidelberg
- Peter MacCallum Cancer Centre - Melbourne
- Royal Melbourne Hospital - Parkville
Bruxelles-capitale, Région de
- Institut Jules Bordet - Anderlecht
- Cliniques universitaires Saint-Luc - Brussels
Ontario
- The Ottawa Hospital - General Campus - Ottawa
- Sunnybrook Health Sciences - Odette Cancer Centre - Toronto
Saskatchewan
- Saskatoon City Hospital - Saskatoon
- Saskatoon Cancer Center - Saskatoon
Florida
- Mount Sinai Cancer Center - Miami Beach
Tennessee
- The West Clinic, PLLC dba West Cancer Center - Germantown
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 107 participants |
| Start Date | 2022-07-11 |
| Est. Completion | 2027-01-26 |
| Phase | Phase 2 |
What the registry record for NCT05217446 still lists
NCT05217446 is an interventional study that assigns participants to a tested intervention. The registered 107 participants enrollment target is mid-sized for trials with a published cap, below the 184-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT05217446 names 20 study sites across 13 states, led by Arizona, Victoria, Bruxelles-capitale, Région de.
Frequently Asked Questions
What is clinical trial NCT05217446 about?
NCT05217446 is a clinical study titled "A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer". The purpose of this study is to learn about the effects of three study medicines (encorafenib, cetuximab, and pembrolizumab) given together for the treatment of colorectal cancer that: * is metastatic (spread to other parts of the body); * has the condition of genetic hypermutability (tendency to m...
What is the current status of trial NCT05217446?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 107 participants. The study started on 2022-07-11. Estimated completion is 2027-01-26.
What conditions does trial NCT05217446 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT05217446?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Cetuximab (BIOLOGICAL), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT05217446?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05217446 being conducted?
This trial has 20 study locations across Arizona, Florida, Tennessee, Texas, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05217446's enrollment target sits among peer trials
107 22nd of 45 higher than 24 of 45 other Metastatic Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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