Study on Pembrolizumab for Patients with High-Risk Stage III Melanoma After Surgery

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What is this study about?

This clinical trial is focused on studying a type of skin cancer called Stage III melanoma. Melanoma is a serious form of skin cancer that can spread to other parts of the body. The study is specifically looking at patients who have had a complete surgical removal of high-risk Stage III melanoma, which means the cancer has spread to the lymph nodes but has been fully removed by surgery. The trial is testing a treatment called pembrolizumab, also known by its code name MK-3475, which is an anti-PD-1 monoclonal antibody. This is a type of medication that helps the immune system recognize and attack cancer cells. The study will compare pembrolizumab to a placebo to see if it can help prevent the cancer from coming back.

The purpose of the study is to find out if pembrolizumab can improve the time patients remain free from cancer after surgery, known as recurrence-free survival. The study will also look at a subgroup of patients whose tumors have a specific protein called PD-L1 to see if pembrolizumab is more effective for them. Participants in the study will receive either pembrolizumab or a placebo through an intravenous infusion, which means the medication is given directly into a vein. The treatment will be administered over a period of up to 52 weeks, and patients will be monitored regularly to check for any signs of the cancer returning.

Throughout the study, patients will undergo regular check-ups and imaging tests like CT or MRI scans to monitor their health and the status of their cancer. The study aims to provide valuable information on whether pembrolizumab can help prevent the recurrence of melanoma after surgery, potentially offering a new treatment option for patients with high-risk Stage III melanoma. The trial is expected to continue until 2026, and the results will help determine the effectiveness of pembrolizumab in improving outcomes for melanoma patients.

1 Initial Enrollment

Upon joining the study, the patient undergoes a registration process. This involves providing written consent for tumor testing and ensuring eligibility based on specific criteria, such as age and medical history.

A tumor sample is required for PD-L1 expression testing. This sample must be sent to a central laboratory for evaluation.

2 PD-L1 Expression Confirmation

The central laboratory confirms the PD-L1 expression status of the tumor sample. This step is necessary before proceeding to the next phase of the trial.

3 Randomization and Treatment Assignment

After confirmation of PD-L1 expression, the patient is enrolled and randomly assigned to one of two treatment groups: either receiving the pembrolizumab (KEYTRUDA) or a placebo.

The treatment involves intravenous administration of pembrolizumab at a concentration of 25 mg/mL. The specific dosage and frequency are determined by the study protocol.

4 Treatment Administration

The patient receives the assigned treatment intravenously. The treatment schedule is designed to improve recurrence-free survival in patients with high-risk Stage III melanoma.

The duration of the treatment is determined by the study protocol and continues until the study’s end date or until specific criteria for discontinuation are met.

5 Monitoring and Follow-up

Throughout the trial, the patient’s health and response to the treatment are closely monitored. This includes regular medical examinations and imaging tests to assess disease status.

The primary goal is to evaluate recurrence-free survival, with additional assessments for distant metastases-free survival and overall survival.

Who Can Join the Study?

  • Must be at least 18 years old.
  • Must not have melanoma in the mucous membranes or eyes.
  • Melanoma with unknown origin is allowed.
  • Must have had a complete removal of Stage III melanoma that has spread to lymph nodes.
  • No history of melanoma spreading to nearby skin areas or having small satellite tumors.
  • Must provide a tumor sample for testing a protein called PD-L1. This sample should not have been treated with radiation before.
  • Must have a test to confirm the presence of PD-L1 in the tumor.
  • Must have had surgery to remove affected lymph nodes, following specific guidelines for the procedure.
  • Must start treatment within 13 weeks after surgery, and only after the surgical wounds have healed.
  • Must have a full body scan to confirm no signs of cancer after surgery.
  • Must not have any signs of cancer returning or spreading to other parts of the body, including the brain.
  • Must have a known or untested status for a gene change called BRAF mutation.
  • Must have a good general health status, known as ECOG performance status of 0 or 1.
  • Must have healthy organs.
  • Must not have had any treatment for melanoma other than surgery, except for a specific treatment called IFN for certain cases.
  • Must not have a history of lung inflammation that required treatment with steroids.
  • Must not have any other active cancer, except for certain types that have been treated successfully.
  • Must not have an active autoimmune disease that needed treatment in the past 2 years.
  • Must not have an active infection that requires treatment.
  • Must not have a weakened immune system or be on immune-suppressing medication.
  • Must not have a history of HIV, active Hepatitis B, or Hepatitis C.
  • Must not have received any live vaccines within 30 days before starting the study treatment.
  • Must not have had previous treatment with certain immune therapies.
  • Must not be participating in another study or have used an investigational treatment recently.
  • Women who can become pregnant must have a negative pregnancy test before starting the study treatment.
  • Women who can become pregnant must use effective birth control during the study and for 120 days after the last treatment dose.
  • Women who are breastfeeding must stop nursing before starting the study treatment and for 120 days after the last treatment dose.
  • Must not have any condition that would prevent following the study protocol and schedule.
  • Must not be directly related to someone involved in conducting the study.

Who Cannot Join the Study?

  • Patients with a different type of cancer than the one being studied.
  • Patients who have not had their cancer completely removed by surgery.
  • Patients with cancer that has spread to other parts of the body beyond the lymph nodes.
  • Patients who have received certain treatments for their cancer in the past.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients who have allergies to the study medication.
  • Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oslo Universitetssykehus HF Oslo Norway
Medizinische Hochschule Hannover Hanover Germany
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Medical University Of Vienna Vienna Austria
Universitaetsmedizin Goettingen Goettingen Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Medical University Of Graz Graz Austria
University Hospital Maastricht Maastricht The Netherlands
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Istituto Europeo Di Oncologia S.r.l. Milan Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario 12 De Octubre Madrid Spain
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E. Porto Portugal
Wielkopolskie Centrum Onkologii Im. Marii Sklodowskiej-Curie Poznan Poland
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Odense University Hospital Odense Denmark
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Hospital Clinic De Barcelona Barcelona Spain
Stichting Radboud University Medical Center Nijmegen The Netherlands
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. Lisbon Portugal
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Pirkanmaan hyvinvointialue Tampere Finland
Netherlands Cancer Institute Amsterdam The Netherlands
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Cmippofrk Umtsqdnvrgbxlu Sndrulhol Woluwe-Saint-Lambert Belgium
Cfzynb Lxnj Brjuez Lyon France
Uqtabvkqpbyurkwsqzwif Epvsa Axf Essen Germany
Ibtart Itexufjo Flzmesctwxetb Onnmgtmbpbt Rome Italy
Upnkgbawgqmz Mspmrtv Cpbpctz Gjwybjsbq Groningen The Netherlands
Iilwxkmj Jhjap Bskahh Brussels Belgium
Aedpnsldhr Pozabrdw &utemqb Hfjqhazw dn Pjron &jyfsyv Hvsjruq Cvubjw &sfzcdq Sbwb Teywszk Paris France
Cnx Apwstdzhwzenerl &kdnwsy Srag Sep Salouel France
Hisnmi Hsyzzqxq Herlev Denmark
Acjgxfgel Ucp Amsterdam The Netherlands
Axihmvigxc Pdntkivk Hcfkxfnu Dk Mzwankzwk Marseille France
Hgtdj Byhoqr He Bergen Norway
Bepzklad Updmczsdzp Hdnpgkeb Cspawl Besançon France
Hjxvuccj Ulyzkaxppj Cysjbuh Huqqfauf Helsinki Finland
Aopwsbq Oraohsrxhzg Uhbyinfzcknuc Szfnxh Siena Italy
Aspggy Ujqelkzdtu Hbbznvhu Aarhus Denmark
Cukbem Hjjvgknryhj Rfiqgdda Uqrveqprkuihn Dr Tbpvr Tours France
Airvtbz Ozhhqnzvwiq Urismvgoycckg Cbgntpgqannv Dwtrb Skhsgx E Dwsbu Snoemfq Df Tclnss Turin Italy
Nyafaave Ifaednuh Odwxzptvq Ipa Mvtke Skmkxklrtduogstfpshcyxxxdxcg Iulrsdpc Bbwxdzpa Cracow Poland
Kmhloafl dxv Ufsliviqlbqd Mkzzmfxh Anm Munich Germany
Aqcrhrt Oaolwipgkyv Pyvi Gsmraosc Xemvf Bergamo Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
02.10.2015
Belgium Belgium
Not recruiting
02.10.2015
Denmark Denmark
Not recruiting
02.10.2015
Finland Finland
Not recruiting
02.10.2015
France France
Not recruiting
02.10.2015
Germany Germany
Not recruiting
02.10.2015
Italy Italy
Not recruiting
02.10.2015
Norway Norway
Not recruiting
02.10.2015
Poland Poland
Not recruiting
02.10.2015
Portugal Portugal
Not recruiting
02.10.2015
Spain Spain
Not recruiting
02.10.2015
Sweden Sweden
Not recruiting
02.10.2015
The Netherlands The Netherlands
Not recruiting
02.10.2015

Trial locations

Investigated drugs:

Pembrolizumab: This medication is an immunotherapy drug used in the trial to help the body’s immune system fight cancer. It is specifically being tested to see if it can improve the time patients remain free from melanoma returning after they have had surgery to remove high-risk Stage III melanoma. Pembrolizumab works by blocking a specific protein that can stop the immune system from attacking cancer cells, thereby potentially preventing the cancer from coming back.

Investigated diseases:

Stage III Melanoma – This is a type of skin cancer that has spread to the lymph nodes but not to distant parts of the body. It is classified into sub-stages IIIA, IIIB, and IIIC, based on the size and extent of the spread to the lymph nodes. In Stage IIIA, the cancer has metastasized to lymph nodes with metastasis greater than 1 mm. Stage IIIB and IIIC involve more extensive lymph node involvement, but without in-transit metastases, which means the cancer has not spread to areas between the primary tumor and the lymph nodes. The progression of Stage III melanoma involves the potential for further spread to other parts of the body if not managed.

Trial ID:
2023-509136-25-00
Protocol code:
MK3475-054
Trial Phase:
Therapeutic confirmatory (Phase III)

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