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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05217446
Registration number
NCT05217446
Ethics application status
Date submitted
19/01/2022
Date registered
1/02/2022
Date last updated
30/04/2024
Titles & IDs
Public title
A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Cancer
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Scientific title
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
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Secondary ID [1]
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2021-003715-26
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Secondary ID [2]
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C4221022
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Universal Trial Number (UTN)
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Trial acronym
SEAMARK
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Encorafenib
Other interventions - Cetuximab
Other interventions - Pembrolizumab
Experimental: Arm A: encorafenib, cetuximab and pembrolizumab - Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.
Active Comparator: Arm B: pembrolizumab - Participants receive pembrolizumab IV.
Treatment: Drugs: Encorafenib
capsule
Other interventions: Cetuximab
IV
Other interventions: Pembrolizumab
IV
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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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:
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Timepoint [1]
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Duration of study, approximately 45 months
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Secondary outcome [1]
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Incidence of adverse events
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Assessment method [1]
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Incidence and severity of AEs graded according to the NCI CTCAE v4.03: encorafenib and cetuximab + pembrolizumab (Arm A) vs pembrolizumab (Arm B)
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Timepoint [1]
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Duration of study, approximately 45 months
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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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)
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Timepoint [2]
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Duration of study, approximately 45 months
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Secondary outcome [3]
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Objective Response (OR)
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Assessment method [3]
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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)
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Timepoint [3]
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Duration of study, approximately 45 months
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Eligibility
Key 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
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/07/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/03/2027
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Actual
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Sample size
Target
104
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [2]
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GenesisCare North Shore - St Leonards
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Gallipoli Medical Research Foundation - Brisbane
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Greenslopes Private Hospital - Greenslopes
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Austin Health - Heidelberg
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [7]
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Royal Melbourne Hospital - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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4120 - Brisbane
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4120 - Greenslopes
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3084 - Heidelberg
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3000 - Melbourne
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Recruitment postcode(s) [7]
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3052 - Parkville
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Recruitment outside Australia
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Antwerpen
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Bruxelles-capitale, Région DE
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Madrid, Comunidad DE
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Madrid
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Stockholms LÄN [se-01]
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Skövde
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London, CITY OF
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United Kingdom
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Birmingham
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Merck Sharp & Dohme LLC
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Commercial sector/Industry
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Merck KGaA, Darmstadt, Germany
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Eli Lilly and Company
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05217446
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for public queries
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Pfizer CT.gov Call Center
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Phone
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1-800-718-1021
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05217446
Download to PDF