Study Comparing Pembrolizumab and Placebo for Patients with Resected High-Risk Stage II Melanoma

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What is this study about?

This clinical trial is focused on studying a type of skin cancer known as Stage II Melanoma, which has been surgically removed but is considered high-risk for returning. The study is comparing two treatments: a medication called Pembrolizumab (also known by its code name MK-3475) and a placebo. Pembrolizumab is a type of drug that is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. It is designed to help the body’s immune system fight cancer cells.

The purpose of this study is to see if Pembrolizumab can help prevent the cancer from coming back after surgery. Participants in the study will be randomly assigned to receive either Pembrolizumab or a placebo. The study will be conducted over a period of time, and participants will receive regular infusions and follow-up care to monitor their health and the status of their cancer. The main goal is to compare how long participants remain free from cancer recurrence between the two groups.

Throughout the study, researchers will also look at other important outcomes, such as how long participants live without the cancer spreading to other parts of the body, overall survival rates, and any side effects experienced. This information will help determine the effectiveness and safety of Pembrolizumab as a treatment option for high-risk Stage II Melanoma.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups: one receiving pembrolizumab and the other receiving a placebo (normal saline). This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

2 treatment administration

Participants receive their assigned treatment through an intravenous infusion. The treatment consists of KEYTRUDA (pembrolizumab) at a concentration of 25 mg/mL or a placebo. The infusion is administered at regular intervals as determined by the study protocol.

3 monitoring and follow-up

Participants are monitored for recurrence-free survival (RFS), which is the primary goal of the study. This involves regular check-ups and imaging to ensure there is no return of melanoma.

Secondary outcomes include monitoring for distant metastasis-free survival (DMFS), overall survival (OS), and recording any adverse events (AEs) experienced by participants. The number of participants who discontinue treatment due to adverse events is also tracked.

4 completion of study

The study is estimated to conclude by October 12, 2033. Participants will continue to be monitored until the end of the study to gather comprehensive data on the long-term effects and efficacy of the treatment.

Who Can Join the Study?

  • The patient must be 12 years or older.
  • The patient must have a new diagnosis of Stage IIB or IIC cutaneous melanoma. This means a type of skin cancer that has been confirmed by examining tissue under a microscope.
  • The patient must have had the melanoma completely removed by surgery and not received any other treatment for it.
  • The time between the last surgery and joining the study must be 12 weeks or less.
  • The patient must have no signs of cancer spreading to other parts of the body, as shown by medical imaging tests.
  • The patient must have a good level of daily functioning. This is measured by specific scales: the ECOG Performance Scale or Lansky Play-Performance Scale for those 16 years or younger, and the Karnofsky Performance Scale for those older than 16 but younger than 18. A score of 50 or higher is required.
  • The patient must have recovered well from any side effects or problems from the surgery before starting the study.
  • Female patients must not be pregnant or breastfeeding. If they can have children, they must agree to use birth control during the study and for at least 120 days after the last treatment dose.

Who Cannot Join the Study?

  • Patients who have not had surgery to remove the melanoma.
  • Patients who do not have high-risk Stage II melanoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have had another type of cancer in the past, unless it was treated and is no longer active.
  • Patients who have an infection that is not well controlled.
  • Patients who have a history of allergic reactions to the study medication.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Katholieke Universiteit te Leuven Leuven Belgium
Medizinische Hochschule Hannover Hanover Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Mannheim GmbH Mannheim Germany
Centre Hospitalier Universitaire De Montpellier Montpellier France
Istituto Oncologico Veneto Padua Italy
Klinikum Nuernberg Nürnberg Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Hopital Ambroise Pare Boulogne-Billancourt France
IRCCS Ospedale Policlinico San Martino Genoa Italy
Hospital General Universitario De Valencia Valencia Spain
Jessa Ziekenhuis Hasselt Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
Pratia S.A. Skorzewo Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer Barcelona Spain
Fondazione Luigi Maria Monti Rome Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
SRH Wald-Klinikum Gera GmbH Gera Germany
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Fundacion Onkologikoa Fundazioa Donostia / San Sebastian Spain
Beskidzkie Centrum Onkologii Szpital Miejski Im. Jana Pawla II W Bielsku-Bialej SPZOZ Bielsko-Biala Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Lift Med S.A. Rybnik Poland
Ccopoy Hqhwqdgttmf Uoxwhnwxuzuoj Aolvym Pwhatisp Amiens France
Cyjwni Hgaxfslozai Uxdxovtqufqfv Du Dbsdc Dijon France
Irksqlmo Rfqecsuav Pqa Ly Sgferb Dik Trubhc Deyz Amfdznw Iave Safivb Meldola Italy
Auvgyqetxg Pvobsjbv Hywqkyhk Dc Pkqhp Paris France
Cakukitmc Unwrncoxvbkbzp Sbuktijny Woluwe-Saint-Lambert Belgium
Azqspimayr Pmyqxmbs Hmonvblc Di Mdevxstrz Marseille France
Ahcegdq Ojlkivaienr Uhbyfsojtqigw Srwpth Siena Italy
Luuzqu Mttlkqnilt Usvoutouxa Oe Mmrqdk Munich Germany
Ufvkuihjokrgjyisvwdps Wihxqusmv Ate Wuerzburg Germany
Urlidxqiim Myxcsjk Cdmifz Hfldssfvrnvpdzgik Hamburg Germany
Agmzqyl Osilmvoxqde Pjcs Gqkxlyvx Xpvee Bergamo Italy
Uagfjprtrtnwekxipnbse Eycci Amr Essen Germany
Cirwgb Hyaeaeegyle Rzbxyomf Djoddezdmugcwc Angers France
Hswiaenk Vvhj dkqjjshq Barcelona Spain

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
11.09.2018
France France
Not recruiting
11.09.2018
Germany Germany
Not recruiting
11.09.2018
Italy Italy
Not recruiting
11.09.2018
Poland Poland
Not recruiting
11.09.2018
Spain Spain
Not recruiting
11.09.2018

Trial locations

Investigated drugs:

Pembrolizumab is a medication used in this clinical trial to help prevent the recurrence of melanoma, a type of skin cancer, after it has been surgically removed. It works by helping the immune system recognize and attack cancer cells, potentially reducing the risk of the cancer coming back.

Resected High-Risk Stage II Melanoma – This is a type of skin cancer that has been surgically removed but is considered high-risk due to its potential to return or spread. Melanoma originates in the pigment-producing cells of the skin and can be more aggressive than other skin cancers. In Stage II, the cancer is thicker and may have ulcerated, but it has not spread to nearby lymph nodes or distant sites. After resection, there is a focus on monitoring for recurrence, as the risk of the cancer returning is significant. The progression of this disease involves careful observation for any signs of the cancer coming back or spreading to other parts of the body.

Trial ID:
2022-501966-23-00
Protocol code:
MK-3475-716
Trial Phase:
Therapeutic confirmatory (Phase III)

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