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Monoclonal Antibodies
Encorafenib + Cetuximab and Pembrolizumab for Colorectal Cancer (SEAMARK Trial)
Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have not received prior systemic regimens for metastatic disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study, approximately 45 months
Awards & highlights
SEAMARK Trial Summary
This trial is studying the effects of 3 drugs given together for colorectal cancer that has spread, is hypermutatable, or has impaired DNA repair. 1 drug is given by IV, and the other 2 are taken orally at home.
Who is the study for?
This trial is for adults with metastatic colorectal cancer that has specific genetic features (MSI-H/dMMR and BRAF V600E mutation), no prior treatments for metastatic disease, good performance status (ECOG 0 or 1), measurable disease, and adequate organ function. It excludes those with certain mutations, brain metastases, pancreatitis, recent live vaccines, previous treatment with similar drugs or immunotherapies.Check my eligibility
What is being tested?
The study tests the combination of Encorafenib plus Cetuximab taken orally at home along with Pembrolizumab given via IV at a clinic compared to just Pembrolizumab alone. The goal is to see if this combo is more effective in treating patients who haven't had any previous systemic treatments for their advanced colorectal cancer.See study design
What are the potential side effects?
Potential side effects include skin reactions from Cetuximab; fatigue, itching or rash from Pembrolizumab; and joint pain or nausea from Encorafenib. There may also be risks of infection due to immune system effects from these medications.
SEAMARK Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I haven't had any systemic treatments for my cancer since it spread.
Select...
I am fully active or can carry out light work.
Select...
My stage IV colorectal cancer is MSI-H/dMMR positive.
Select...
My cancer has a BRAF V600E mutation.
SEAMARK Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration of study, approximately 45 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study, approximately 45 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free Survival (PFS)
Secondary outcome measures
Incidence of adverse events
Objective Response (OR)
Overall Survival (OS)
Side effects data
From 2022 Phase 3 trial • 702 Patients • NCT0292822478%
Diarrhoea
68%
Dermatitis acneiform
59%
Nausea
54%
Fatigue
51%
Vomiting
51%
Dry Skin
43%
Pyrexia
43%
Anaemia
41%
Decreased appetite
38%
Abdominal pain
38%
Constipation
35%
Dyspnoea
32%
Vision blurred
30%
Blood creatine increased
30%
Blood creatine phosphokinase increased
24%
Arthralgia
24%
Myalgia
24%
Skin fissures
22%
Back Pain
22%
Dizziness
19%
Malaise
19%
Urinary tract infection
19%
Headache
19%
Aspartate aminotransferase increased
16%
Asthenia
16%
Oedema peripheral
16%
Stomatitis
16%
PPE syndrome
16%
Hypomagnesaemia
16%
Rash maculo-papular
16%
Palmar-planar erythrodysaesthesia
16%
Chills
16%
Paronychia
16%
Rash pustular
16%
Alanine aminotransferase increased
16%
Dysgeusia
16%
Peripheral sensory neuropathy
14%
Cough
14%
Abdominal pain upper
14%
Infusion-related reaction
14%
Ejection fraction decreased
14%
Dry eye
11%
Trichiasis
11%
Vitreous floaters
11%
Pollakiuria
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Weight decreased
8%
Macular oedema
8%
Proteinuria
8%
Rhinitis allergic
8%
Iron deficiency
8%
Nasopharyngitis
8%
Infusion related reaction
8%
Hypertrichosis
8%
Visual impairment
8%
Hypokalaemia
8%
Flank pain
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Pleural effusion
5%
Rectal haemorrhage
5%
Hypophosphataemia
5%
Bone pain
5%
Restless legs syndrome
5%
Pruritus generalised
5%
Chorioretinopathy
5%
Trichomegaly
5%
Urinary incontinence
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Hypocalcaemia
5%
Nervous system disorder
5%
Ascites
5%
Abdominal pain lower
5%
Nail disorder
5%
Colitis
5%
Infection
5%
Wound
5%
Anal haemorrhage
5%
Insomnia
5%
Gastroesophageal reflux disease
5%
Abdominal distension
5%
Eczema
5%
Cystitis
5%
Renal failure
5%
Conjunctivitis
5%
Syncope
5%
Dehydration
5%
Dry Mouth
5%
Skin hyperpigmentation
5%
Muscle spasms
5%
Erythema
5%
Retinal detachment
5%
Pulmonary embolism
5%
Dysphonia
5%
Haematuria
5%
Blood creatinine increased
5%
Depression
5%
Palpitations
3%
Bacterial sepsis
3%
Large intestine perforation
3%
Confusional state
3%
Device occlusion
3%
Large intestinal ulcer hemorrhage
3%
Skin papilloma
3%
Urinary tract infection bacterial
3%
Back pain
3%
Kidney infection
3%
Large intestinal ulcer
3%
Upper respiratory tract infection
3%
Tumour pain
3%
Streptococcal infection
3%
Melanocytic naevus
3%
Cholangitis
3%
Alopecia
3%
Rhabdomyolysis
3%
Hyperkeratosis
3%
Rectal hemorrhage
3%
Urinary tract obstruction
3%
Epistaxis
3%
Colon cancer
3%
Sepsis
3%
Acute kidney injury
3%
Large intestine ulcer
3%
Neutropenia
3%
Bacteria sepsis
3%
Hydronephrosis
3%
Neuropathy peripheral
3%
Abdominal abscess
3%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combined Safety Lead-in
Phase 3: Triplet Arm
Phase 3: Doublet Arm
Phase 3: Control Arm
SEAMARK Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: encorafenib, cetuximab and pembrolizumabExperimental Treatment3 Interventions
Participants receive encorafenib orally + cetuximab IV + pembrolizumab IV.
Group II: Arm B: pembrolizumabActive Control1 Intervention
Participants receive pembrolizumab IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Encorafenib
2021
Completed Phase 3
~960
Cetuximab
2011
Completed Phase 3
~2480
Find a Location
Who is running the clinical trial?
PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,336 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,900 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,552 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any systemic treatments for my cancer since it spread.I have not received a live vaccine in the last 30 days.I have pancreatitis.My cancer has spread to my brain or its coverings.I have been treated with drugs targeting BRAF or EGFR mutations.I am fully active or can carry out light work.My stage IV colorectal cancer is MSI-H/dMMR positive.I haven't had a stroke or serious heart issue in the last 3 months.I have been treated with drugs that target the immune system.My organs are working well.I haven't needed treatment for an autoimmune disease in the last 2 years.My colorectal cancer is either RAS mutant or its RAS status is unknown.My cancer has a BRAF V600E mutation.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: pembrolizumab
- Group 2: Arm A: encorafenib, cetuximab and pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research still available for enrolment?
"Affirmative. Clinicaltrials.gov states that this experiment, which was first published on July 11th 2022, is actively searching for participants. To date, 104 individuals are required to be recruited from 17 separate centres."
Answered by AI
What is the extent of this particular research endeavor?
"USC/Norris Comprehensive Cancer Center / Investigational Drug Services in Phoenix, Arizona, Mayo Clinic Building - Phoenix in Rochester, Minnesota and Mayo Clinic Cancer Centre Outpatient Pharmacy in Brampton Ontario are 3 of the 18 sites involved with this study."
Answered by AI
What is the total enrolment size for this medical experiment?
"Indeed, the clinicaltrials.gov website confirms that this research is recruiting right now. This study was first published on July 11th 2022 and most recently updated on November 16th of the same year. 104 individuals are required to be enrolled from 17 distinct trial sites."
Answered by AI
What adverse effects could be linked to the use of Encorafenib?
"Encorafenib has been assigned a safety grade of 2, due to the absence of efficacy data but confirmation that it is safe from existing Phase2 clinical trial information."
Answered by AI
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