← Back to Search

PD-1 Inhibitor

Pembrolizumab for Merkel Cell Carcinoma

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have histologically confirmed diagnosis of locoregional MCC that has recurred following standard locoregional therapy with surgery and/or radiation therapy and is not amenable to local therapy or metastatic MCC (Stage IV) as per American Joint Committee on Cancer (AJCC) 8th edition guidelines
Have at least 1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1 criteria as determined by the local site investigator/radiology assessment
Must not have
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to C1D1
Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~13 years
Awards & highlights

Summary

This trial is testing a new cancer treatment called pembrolizumab in people with Merkel Cell Carcinoma who have not had treatment before. The goal is to see if it is effective and safe.

Who is the study for?
Adults and children (12+) with advanced Merkel Cell Carcinoma who haven't been treated for their advanced or metastatic disease are eligible. They must have good organ function, agree to use effective contraception, not be pregnant or breastfeeding, and have a performance status that allows daily living activities. Prior therapies are allowed under certain conditions but no recent vaccines or treatments that could affect the trial.Check my eligibility
What is being tested?
The study is testing Pembrolizumab's effectiveness as a first-line treatment for advanced MCC by monitoring tumor response rates. It's an open-label trial where all participants receive the drug; there’s no comparison group.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid), digestive issues, liver problems, and can worsen existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My Merkel cell carcinoma has returned after surgery or radiation, or it has spread widely.
Select...
I have a tumor that can be measured by CT or MRI.
Select...
Side effects from my last treatment are mild or gone, except for hair loss.
Select...
I am mostly active and can carry out daily tasks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
Select...
I have an autoimmune disease treated with strong medication in the last 2 years.
Select...
I have or had lung inflammation that needed steroids.
Select...
I am currently being treated for an infection.
Select...
I have an active tuberculosis infection.
Select...
I haven't had serious heart problems like heart failure, unstable chest pain, heart attack, stroke, or dangerous irregular heartbeat in the last 6 months.
Select...
I have been treated with specific immune therapy for cancer.
Select...
I have had cancer treatment or been in a trial within the last 12 weeks.
Select...
I have received a transplant from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~13 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~13 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Duration of Response (DOR)
Number of Participants Who Discontinued From Study Treatment Due to an AE
Number of Participants With One or More Adverse Events (AEs)
+2 more

Side effects data

From 2024 Phase 3 trial • 55 Patients • NCT03783078
25%
Fatigue
22%
Pruritus
22%
Aspartate aminotransferase increased
20%
Asthenia
18%
Alanine aminotransferase increased
16%
Arthralgia
16%
Back pain
16%
Lipase increased
16%
Constipation
15%
Anaemia
15%
Nausea
13%
Weight decreased
13%
Diarrhoea
13%
Pyrexia
11%
Headache
9%
Decreased appetite
9%
Eczema
9%
Dry mouth
9%
Vomiting
9%
Oedema peripheral
9%
Amylase increased
9%
Rash
7%
Dysgeusia
7%
Dyspnoea
7%
Alopecia
7%
Haematuria
7%
Osteoarthritis
7%
Pain in extremity
7%
Myalgia
7%
Abdominal pain
7%
Blood alkaline phosphatase increased
7%
Blood creatinine increased
5%
Dysuria
5%
Insomnia
5%
Actinic keratosis
5%
Erythema
5%
Vertigo
5%
Hyperthyroidism
5%
Blood creatine phosphokinase increased
4%
Basal cell carcinoma
4%
Pulmonary embolism
2%
Cerebral haemorrhage
2%
Chronic inflammatory demyelinating polyradiculoneuropathy
2%
Small intestinal obstruction
2%
Erysipelas
2%
Encephalitis
2%
Squamous cell carcinoma
2%
Obstructive pancreatitis
2%
Subileus
2%
Squamous cell carcinoma of skin
2%
Transitional cell carcinoma
2%
Guillain-Barre syndrome
2%
Loss of consciousness
2%
Muscular weakness
2%
Cerebrovascular accident
2%
Empyema
2%
Cellulitis
2%
Pneumonia
2%
Colitis
2%
Dysphagia
2%
Respiratory syncytial virus infection
2%
Upper respiratory tract infection
2%
Wound infection
2%
Parkinson's disease
2%
Acute kidney injury
2%
Dyspnoea exertional
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab 200 mg

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab (MK-3475) 200 mg (adult participants) or 2 mg/kg (up to 200 mg; pediatric participants) on Day 1 of each 3-week cycle (Q3W) intravenous (IV), for up to 35 administrations (approximately 2 years)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab (MK-3475)
2019
Completed Phase 3
~240

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,957 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,919 Previous Clinical Trials
5,068,208 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,801 Previous Clinical Trials
8,070,275 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03783078 — Phase 3
Neuroendocrine Carcinoma Research Study Groups: Pembrolizumab
Neuroendocrine Carcinoma Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03783078 — Phase 3
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03783078 — Phase 3
~9 spots leftby Jul 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top