Your session is about to expire
← Back to Search
Checkpoint Inhibitor
Pembrolizumab for High-risk Stage II Melanoma
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
Has not been previously treated for melanoma beyond complete surgical resection
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or Lansky Play-Performance Scale (LPS) score ≥50 for participants ≤16 years old, or a Karnofsky Performance Scale (KPS) score ≥50 for participants >16 and <18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~15 years
Awards & highlights
Study Summary
This trial will evaluate the safety and efficacy of pembrolizumab compared to placebo in participants with surgically resected high-risk Stage II melanoma. The primary hypothesis is that pembrolizumab increases recurrence-free survival.
Who is the study for?
This trial is for individuals with a new diagnosis of high-risk Stage II melanoma that's been surgically removed. They haven't had other melanoma treatments, are within 12 weeks post-surgery, and show no metastasis. Participants must be in good physical condition (ECOG score 0 or 1) and not pregnant or breastfeeding, agreeing to use contraception.Check my eligibility
What is being tested?
The study tests pembrolizumab against a placebo in people who've had high-risk Stage II melanoma surgery. It's double-blind at first: patients get either the drug or placebo every three weeks for about a year. If the cancer returns, they can get more pembrolizumab openly for up to two years.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects like inflammation in various organs, skin reactions, fatigue, flu-like symptoms, hormonal gland problems (like thyroid), and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have only had surgery for my melanoma, no other treatments.
Select...
I am mostly active and can carry out daily activities without significant help.
Select...
My melanoma was surgically removed and confirmed to be Stage IIB or IIC.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence-free Survival (RFS)
Secondary outcome measures
Distant Metastasis-free Survival (DMFS)
Number of Participants Who Discontinued Study Treatment Due to an AE
Number of Participants Who Experienced at Least One Adverse Event (AE)
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PembrolizumabExperimental Treatment1 Intervention
Participants receive 200 mg pembrolizumab (2 mg/kg for a maximum of 200 mg in pediatric participants) by intravenous (IV) infusion once every 3 weeks (Q3W; 21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of pembrolizumab and experience disease recurrence may be eligible for re-challenge with pembrolizumab at the same dose and schedule of 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
Group II: PlaceboPlacebo Group2 Interventions
Participants receive saline placebo by IV infusion Q3W (21-day cycles) for up to 17 cycles (up to ~1 year) in Part 1. Participants who complete the initial treatment of 17 cycles of placebo and experience disease recurrence may be eligible to switch over to pembrolizumab 200 mg Q3W (21-day cycles) for up to 35 cycles (up to ~2 years) in Part 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,580,846 Total Patients Enrolled
31 Trials studying Melanoma
8,486 Patients Enrolled for Melanoma
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,595 Total Patients Enrolled
120 Trials studying Melanoma
20,706 Patients Enrolled for Melanoma
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,504 Total Patients Enrolled
35 Trials studying Melanoma
10,328 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have not received a live vaccine in the last 30 days.You have been diagnosed with HIV.I have only had surgery for my melanoma, no other treatments.It has been less than 12 weeks since my last surgery.I am mostly active and can carry out daily activities without significant help.I am not pregnant or breastfeeding and agree to use birth control if I can have children.I have been treated with specific immune therapy for cancer.I have received treatment for melanoma before, including experimental drugs.I have an autoimmune disease treated with medication in the last 2 years.I have a history of hepatitis B or active hepatitis C.I have received a transplant from another person.I have not had active cancer treatment in the past 5 years, except for certain skin cancers or localized cancers that were treated.I have had pneumonitis treated with steroids or have it now.The doctor has not found any signs of the cancer spreading to other parts of the body in the imaging tests.You have a severe allergic reaction (Grade 3 or higher) to any of the ingredients in pembrolizumab.I have had active tuberculosis in the past.My melanoma was surgically removed and confirmed to be Stage IIB or IIC.I have recovered from any side effects of surgery before starting the study.I am currently being treated for an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Pembrolizumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Has Pembrolizumab gained official government sanctioning in the United States?
"Pembrolizumab is considered safe based on our evaluation because it is a Phase 3 trial drug."
Answered by AI
How many participants are required for this clinical trial?
"This particular trial has ceased recruiting patients. The listing was created on September 12th, 2018 and was updated on October 31st, 2020. At the moment, there are 779 other trials for melanoma and 999 for Pembrolizumab that are looking for patients to enroll."
Answered by AI
Are we still enrolling volunteers for this experiment?
"The clinicaltrials.gov website shows that this study is not looking for new participants at the moment. This research was originally published on September 12th, 2018 but was updated on October 31st, 2020. There are currently 1,778 other clinical trials that are recruiting patients."
Answered by AI
What other forms of research have been done on Pembrolizumab?
"Pembrolizumab was first researched in 2010 by the City of Hope. So far, there have been 18,479 clinical trials completed with 999 more currently active. A large concentration of these active studies are located in La Jolla, Georgia."
Answered by AI
At how many different sites is this research project being conducted?
"This trial has already enrolled 49 patients from locations such as UCSD Moores Cancer Center ( Site 0133) in La Jolla, Winship Cancer Institute of Emory University ( Site 0046) in Atlanta, and Northwestern Medical Group ( Site 0135) in Chicago."
Answered by AI
What are some of Pembrolizumab's most common applications?
"Pembrolizumab is a common treatment for malignant neoplasms. It can also shrink tumors in patients with unresectable melanoma, microsatellite instability high, and those that have experienced disease progression after chemotherapy."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger