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PD-1 Inhibitor

Pembrolizumab for Merkel Cell Carcinoma

Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be male or female and at least 12 years of age, at the time of signing the informed consent/assent
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~13 years
Awards & highlights

Study 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
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I am at least 12 years old and can consent to treatment.
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My Merkel cell carcinoma has returned after surgery or radiation, or it has spread widely.
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I haven't been treated for advanced cancer, but I may have had certain previous treatments.
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I have a tumor that can be measured by CT or MRI.
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Side effects from my last treatment are mild or gone, except for hair loss.
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I am not pregnant or breastfeeding, and if I can have children, I use effective birth control or practice abstinence.
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I am mostly active and can carry out daily tasks.
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My organs are working well.

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%
Constipation
16%
Lipase increased
16%
Arthralgia
16%
Back pain
15%
Anaemia
15%
Nausea
13%
Diarrhoea
13%
Pyrexia
13%
Weight decreased
11%
Headache
9%
Eczema
9%
Dry mouth
9%
Vomiting
9%
Oedema peripheral
9%
Amylase increased
9%
Decreased appetite
9%
Rash
7%
Dyspnoea
7%
Dysgeusia
7%
Alopecia
7%
Haematuria
7%
Abdominal pain
7%
Blood alkaline phosphatase increased
7%
Blood creatinine increased
7%
Myalgia
7%
Osteoarthritis
7%
Pain in extremity
5%
Actinic keratosis
5%
Insomnia
5%
Dysuria
5%
Erythema
5%
Vertigo
5%
Hyperthyroidism
5%
Blood creatine phosphokinase increased
4%
Basal cell carcinoma
4%
Pulmonary embolism
2%
Loss of consciousness
2%
Guillain-Barre syndrome
2%
Pneumonia
2%
Colitis
2%
Dysphagia
2%
Obstructive pancreatitis
2%
Small intestinal obstruction
2%
Subileus
2%
Cellulitis
2%
Empyema
2%
Encephalitis
2%
Erysipelas
2%
Respiratory syncytial virus infection
2%
Upper respiratory tract infection
2%
Wound infection
2%
Muscular weakness
2%
Squamous cell carcinoma
2%
Squamous cell carcinoma of skin
2%
Transitional cell carcinoma
2%
Cerebral haemorrhage
2%
Cerebrovascular accident
2%
Chronic inflammatory demyelinating polyradiculoneuropathy
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 LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,645 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,856 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,145 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the Pembrolizumab (MK-3475) patient safety profile like?

"Pembrolizumab (MK-3475) has received a 3 for safety. This is due to the fact that it is a Phase 3 trial, meaning there is both efficacy and safety data supporting its use."

Answered by AI

Are we still looking for participants in this experiment?

"At the moment, this study is not enrolling patients. According to the information available on clinicaltrials.gov, it was first posted on February 25th, 2019 and last updated on July 8th, 2022. However, there are presently 2555 other clinical trials actively recruiting patients with carcinoma and 1000 studies for Pembrolizumab (MK-3475) that need participants."

Answered by AI

Are there other investigations that have been done using Pembrolizumab (MK-3475)?

"Pembrolizumab (MK-3475) is being studied in 1000 live clinical trials, with 122 of those studies in Phase 3. The majority of Pembrolizumab (MK-3475) trials are based out of Houston, Texas; however, there are 36021 locations running Pembrolizumab (MK-3475) trials globally."

Answered by AI

What are Pembrolizumab's (MK-3475) therapeutic indications?

"Pembrolizumab (MK-3475) is the standard care for patients with malignant neoplasms. Additionally, this immunotherapy drug has shown efficacy in treating other conditions like unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

How many people meet the requirements to participate in this trial?

"This study is no longer recruiting patients for participation. The original posting date was February 25th, 2019 and the most recent update was on July 8th, 2022. However, there are still over 2500 active clinical trials searching for participants with carcinoma and 1000 studies related to Pembrolizumab (MK-3475)."

Answered by AI
~9 spots leftby Mar 2025