A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
Running, not enrolling · Phase 2
Conditions studied: Metastatic Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT05217446
- Run by
- Pfizer
- People needed
- 108
- Starts
- 2022-07-11
- Expected to finish
- 2027-01-26
- Last updated by the study team
- 2026-07-31
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
- Locally confirmed BRAF V600E mutation in tumor tissue or blood
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Have not received prior systemic regimens for metastatic disease.
- Measurable disease per RECIST 1.1
- Adequate organ function
You may not qualify if…
- Colorectal adenocarcinoma that is RAS mutant or for which RAS mutation status is unknown
- Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
- Immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
- Presence of acute or chronic pancreatitis
- Clinically significant cardiovascular diseases (eg, thromboembolic or cerebrovascular accident events ≤ 12 wks prior)
- Received a live or live-attenuated vaccine within 30 days of planned start of study medication
- Previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
- Previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
Where it is running
- Mayo Clinic Hospital — Phoenix, Arizona, United States
- Mayo Clinic — Scottsdale, Arizona, United States
- Mount Sinai Cancer Center — Miami Beach, Florida, United States
- The West Clinic, PLLC dba West Cancer Center — Germantown, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Austin Health — Heidelberg, Victoria, Australia
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
- Royal Melbourne Hospital — Parkville, Victoria, Australia
- Imelda General Hospital — Bonheiden, Antwerpen, Belgium
- Institut Jules Bordet — Anderlecht, Bruxelles-capitale, Région de, Belgium
- Cliniques universitaires Saint-Luc — Brussels, Bruxelles-capitale, Région de, Belgium
- The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada
- Sunnybrook Health Sciences - Odette Cancer Centre — Toronto, Ontario, Canada
- Saskatchewan Health Authority — Saskatoon, Saskatchewan, Canada
- Saskatoon Cancer Center — Saskatoon, Saskatchewan, Canada
- Fakultni nemocnice Hradec Kralove — Hradec Králové, Hradec Králové, Czechia
- Fakultni Thomayerova nemocnice — Prague, Praha 4, Czechia
- Fakultni nemocnice Bulovka — Prague, Praha 8, Czechia
- Herlev and Gentofte Hospital — Copenhagen, Capital Region, Denmark
- Rigshospitalet — Copenhagen, Capital, Denmark
- Aalborg Universitetshospital, Syd — Aalborg, North Denmark, Denmark
- Vejle Hospital, Department of Oncology — Vejle, Region Syddanmark, Denmark
- Vejle Sygehus — Vejle, Region Syddanmark, Denmark
- Hôpital Européen Georges Pompidou — Paris, Paris, France
- Mayo Clinic Building - Phoenix — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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