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Pfizer Oncology
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The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.

Clinical Trial Details

Geo Regions

Category

Gastrointestinal Cancer

Encorafenib

A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER

Phase 2

NCT05217446

Active Not-enrolling

Globe

Locations

United States, Australia, Belgium, Canada, Czechia, Denmark, France, Germany, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, United Kingdom

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Study design
Participant Group/Arm

EXPERIMENTAL: Arm A: encorafenib, cetuximab and pembrolizumab

Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.

Intervention/Treatment

DRUG: Encorafenib

capsule

BIOLOGICAL: Cetuximab

IV

BIOLOGICAL: Pembrolizumab

IV
Participant Group/Arm

ACTIVE_COMPARATOR: Arm B: pembrolizumab

Participants receive pembrolizumab IV.

Intervention/Treatment

BIOLOGICAL: Pembrolizumab

IV
Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
  • 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
Exclusion criteria
  • 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).
Key dates
Study start date
  • July 2022
Estimated Study Completion Date
  • March 2027
Key endpoints
Primary Outcome Measures
Outcome Measure

Progression-free Survival (PFS)

Measure Description

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:

Time Frame

Duration of study, approximately 45 months

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Incidence of adverse events

Measure Description

Incidence and severity of AEs graded according to the NCI CTCAE v4.03: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)

Time Frame

Duration of study, approximately 45 months

Outcome Measure

Overall Survival (OS)

Measure Description

OS is defined as the time from the date of randomization to the date of death due to any cause: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)

Time Frame

Duration of study, approximately 45 months

Outcome Measure

Objective Response (OR)

Measure Description

OR is defined as a CR or PR per RECIST version 1.1 recorded from the date of randomization until date of first documentation of PD, death, or start of new anti-cancer therapy: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)

Time Frame

Duration of study, approximately 45 months

Secondary Outcome Measures table for Clinical Trial
Number of participants

101

Collaborators and investigators

Sponsor: Pfizer

Collaborator: Merck Sharp & Dohme LLC, Merck KGaA, Darmstadt, Germany, Eli Lilly and Company

This information is current as of November 13th 2024.

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For more information, call or email the Pfizer Clinical Trial Contact Center:

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When calling, please reference this study number:

More Information Close NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier. NCT05217446