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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
Must not have
Received a live or live-attenuated vaccine within 30 days of planned start of study medication
Known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study, approximately 45 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had any systemic treatments for my cancer since it spread.
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I am fully active or can carry out light work.
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My stage IV colorectal cancer is MSI-H/dMMR positive.
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My cancer has a BRAF V600E mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine in the last 30 days.
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My cancer has spread to my brain or its coverings.
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I have been treated with drugs targeting BRAF or EGFR mutations.
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I haven't had a stroke or serious heart issue in the last 3 months.
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I have been treated with drugs that target the immune system.
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I have pancreatitis.
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I haven't needed treatment for an autoimmune disease in the last 2 years.
Select...
My colorectal cancer is either RAS mutant or its RAS status is unknown.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of study, approximately 45 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study, approximately 45 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-free Survival (PFS)
Secondary study objectives
Incidence of adverse events
Objective Response (OR)
Overall Survival (OS)

Side effects data

From 2022 Phase 3 trial • 702 Patients • NCT02928224
78%
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%
Stomatitis
16%
Oedema peripheral
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%
Pollakiuria
11%
Vitreous floaters
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Rhinitis allergic
8%
Hypokalaemia
8%
Visual impairment
8%
Infusion related reaction
8%
Macular oedema
8%
Hypertrichosis
8%
Iron deficiency
8%
Nasopharyngitis
8%
Weight decreased
8%
Flank pain
8%
Proteinuria
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Pleural effusion
5%
Restless legs syndrome
5%
Nervous system disorder
5%
Wound
5%
Trichomegaly
5%
Infection
5%
Hypocalcaemia
5%
Hypophosphataemia
5%
Rectal haemorrhage
5%
Musculoskeletal pain
5%
Anal haemorrhage
5%
Ascites
5%
Colitis
5%
Abdominal pain lower
5%
Nail disorder
5%
Pruritus generalised
5%
Bone pain
5%
Musculoskeletal chest pain
5%
Chorioretinopathy
5%
Urinary incontinence
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%
Tumour pain
3%
Urinary tract infection bacterial
3%
Large intestinal ulcer
3%
Kidney infection
3%
Large intestinal ulcer hemorrhage
3%
Melanocytic naevus
3%
Epistaxis
3%
Hyperkeratosis
3%
Rectal hemorrhage
3%
Streptococcal infection
3%
Alopecia
3%
Upper respiratory tract infection
3%
Skin papilloma
3%
Large intestine perforation
3%
Bacterial sepsis
3%
Cholangitis
3%
Urinary tract obstruction
3%
Confusional state
3%
Device occlusion
3%
Back pain
3%
Rhabdomyolysis
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2810
Encorafenib
2022
Completed Phase 3
~970
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,655 Previous Clinical Trials
17,746,154 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,334 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
443 Previous Clinical Trials
114,466 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05217446 — Phase 2
Colorectal Cancer Research Study Groups: Arm B: pembrolizumab, Arm A: encorafenib, cetuximab and pembrolizumab
Colorectal Cancer Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT05217446 — Phase 2
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05217446 — Phase 2
~38 spots leftby Mar 2026
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