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Study on the Safety and Effectiveness of Pembrolizumab for Patients with Kidney Cancer After Surgery

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What is this study about?

This clinical trial is focused on studying a type of kidney cancer known as renal cell carcinoma. The study is investigating the use of a medication called pembrolizumab, which is also known by its code name MK-3475. Pembrolizumab is a treatment given through an intravenous infusion, meaning it is delivered directly into the bloodstream. The purpose of the study is to evaluate the safety and effectiveness of pembrolizumab as a treatment option for patients who have had surgery to remove kidney cancer.

Participants in the study will receive either pembrolizumab or a placebo. The study will monitor how long participants remain free of cancer after treatment, which is referred to as disease-free survival. Additionally, the study will look at overall survival, which measures how long participants live after starting the treatment. The study will also track any side effects experienced by participants and whether any participants stop the treatment due to side effects.

The study will take place over a period of time, with participants receiving treatment and being monitored for changes in their health. Regular assessments will be conducted to check for any recurrence of cancer and to evaluate the overall health and quality of life of the participants. The study aims to provide valuable information on the potential benefits of pembrolizumab for patients with renal cell carcinoma following surgery.

1 joining the study

Upon joining the study, participants will be randomly assigned to receive either the study medication or a placebo. This process is double-blind, meaning neither the participant nor the study team will know which treatment is being administered.

2 treatment administration

Participants will receive the study medication, pembrolizumab, or a placebo through an intravenous infusion. This involves receiving the medication directly into the bloodstream through a vein.

The dosage of pembrolizumab is 25 mg/mL, and it will be administered as a solution for infusion. The frequency and duration of administration will be determined by the study protocol and communicated by the study team.

3 monitoring and assessments

Throughout the study, participants will undergo regular monitoring and assessments to evaluate their health and the effects of the treatment. This may include physical exams, blood tests, and imaging scans such as CT or MRI.

The primary goal is to assess disease-free survival, which means the length of time participants remain free from cancer after treatment.

4 follow-up

After completing the treatment phase, participants will continue to be monitored for any changes in their health status. This follow-up period is crucial for understanding the long-term effects of the treatment.

Participants may be asked to return for periodic check-ups and assessments as part of the study’s follow-up protocol.

Who Can Join the Study?

  • Must have a confirmed diagnosis of renal cell carcinoma (RCC) with a clear cell component, which may or may not have sarcomatoid features.
  • Must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, which means you are fully active or have some symptoms but do not need bed rest during the day.
  • Must have adequate organ function, meaning your organs are working well enough to participate in the study.
  • Female participants who can have children must agree to use a reliable method of birth control during the study and for 120 days after the last dose of the study treatment.
  • Male participants who can father children must agree to use a reliable method of birth control starting with the first dose of study treatment and continuing for 120 days after the last dose.
  • Must have intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by specific medical criteria related to tumor size, grade, and spread.
  • Must not have received any previous systemic therapy for advanced RCC, which means no treatments that affect the entire body, like chemotherapy.
  • Must have had a nephrectomy (surgery to remove a kidney) or a metastasectomy (surgery to remove cancer spread) with no cancer left at the edges of the removed tissue.
  • Must have had the surgery at least 28 days before signing the consent form and no more than 12 weeks before being randomly assigned to a treatment group.
  • Must be tumor-free as confirmed by a doctor and validated by a CT or MRI scan of the brain, chest, abdomen, and pelvis, and a bone scan within 28 days of being randomly assigned to a treatment group.
  • Must have provided adequate tissue samples from surgery for study purposes, depending on the type of surgery and cancer spread.

Who Cannot Join the Study?

  • Patients with any other type of cancer besides renal cell carcinoma (a type of kidney cancer) cannot participate.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cancers (cancers that have not spread), are excluded.
  • Patients with an active infection that requires treatment with antibiotics, antivirals, or antifungals cannot join the study.
  • Patients with an autoimmune disease (a condition where the immune system attacks the body) that requires treatment are not eligible.
  • Patients who have received a live vaccine within 30 days before the start of the study cannot participate.
  • Patients who are pregnant or breastfeeding are excluded from the study.
  • Patients with a history of severe allergic reactions to any of the study drugs or their ingredients cannot join.
  • Patients with a known history of HIV, hepatitis B, or hepatitis C infections are not eligible.
  • Patients who have had major surgery within 4 weeks before starting the study are excluded.
  • Patients who are currently participating in another clinical trial or have done so within the last 4 weeks cannot participate.

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
Comite Entreprise Paul Papin Angers France
University Hospital Jena KöR Jena Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Oncopole Claudius Regaud Toulouse France
Technische Universitaet Dresden Dresden Germany
Hospital Universitario Y Politecnico La Fe Valencia Spain

Other Sites

Site Name City Country Status
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fakultni Nemocnice Brno Brno Czechia
Amphia Hospital Breda The Netherlands
Sint Franciscus Vlietland Groep Stichting Rotterdam The Netherlands
Nemocnice AGEL Novy Jicin a.s. Novy Jicin Czechia
University Hospital Olomouc Olomouc Czechia
Wojewodzki Szpital Specjalistyczny Nr 4 W Bytomiu Samodzielny Publiczny Zaklad Opieki Zdrowotnej Bytom Poland
Centre Antoine Lacassagne Nice France
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Tampere University Hospital Tampere Finland
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Warsaw Poland
Turku University Hospital Turku Finland
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Assistance Publique Hopitaux De Paris Paris France
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Uniwersytecki Szpital Kliniczny W Poznaniu Poznan Poland
Azienda USL Toscana Sud Est Arezzo Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Barmherzige Brueder Trier gGmbH Trier Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Charite Research Organisation GmbH Berlin Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
Fakultni Nemocnice Bulovka Prague Czechia
Clinical Best Solutions Sp. z o.o. S.K. Lublin Poland
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow Poland
Oulu University Hospital Oulu Finland
Central Finland Hospital District Central Finland Hospital Nova Jyvaskyla Finland
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu Torun Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Fakultni Thomayerova nemocnice Prague Czechia
Hopital Saint Eloi Montpellier France
University Hospital Ostrava Ostrava Czechia
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Hospital Universitario Virgen De La Victoria Malaga Spain
Szpital Specjalistyczny W Kościerzynie Sp. z o.o. Koscierzyna Poland
Cqxlmmgtnk Pejraet Lcmyytbfg Smb z ofwa Gdansk Poland
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Pnagpyzqcgp Lagkdqlw &lqitivlajtwbpfnopox Remlp Kbkbagricdv Konin Poland
Ilstfolo Runrxnmov Pvu Lv Szxxxl Dkh Tokxwn Djet Amhocjq Iepu Sgciek Meldola Italy
Aawvjpslub Puvzlflw Hjhjwowv Dt Myvomysqu Marseille France
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Hakdwzpw Uhmjawhyry Caojfuq Hqcncaiu Helsinki Finland
Glflcq Uwsjzreezh Fnpmgsdsi Frankfurt Germany
Hlmwbvpy Dx Lb Spnij Cpyv I Souj Ppb Barcelona Spain
Sm Vdhzlexzquvitgb Ugytstfruu Hqkobrry Dublin Ireland
Umakrykcbb Mpjhynf Crarpl Hkaaqzjbrdbpxvtmw Hamburg Germany
Uydiiwsdukjjjsdrzymlh Ezjqq Afq Essen Germany
Inmgyu Iymjgxrq Fzrivgkcitlut Ostfhxlqdjv Rome Italy
Hdwjzodx Updjaqtrmddrv Dd Bajqxpk Badajoz Spain
Sdjlnhqs Pebvrfyzn Stm z ooip Gdynia Poland

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
15.06.2017
Finland Finland
Not recruiting
15.06.2017
France France
Not recruiting
15.06.2017
Germany Germany
Not recruiting
15.06.2017
Ireland Ireland
Not recruiting
15.06.2017
Italy Italy
Not recruiting
15.06.2017
Poland Poland
Not recruiting
15.06.2017
Spain Spain
Not recruiting
15.06.2017
The Netherlands The Netherlands
Not recruiting
15.06.2017

Trial locations

Investigated drugs:

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help prevent the return of kidney cancer after surgery. It is given to patients who have had their kidney tumor removed to see if it can stop or slow down the cancer from coming back.

Renal cell carcinoma – Renal cell carcinoma is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It typically starts as a single mass or tumor in one kidney, but it can also occur in both kidneys simultaneously. As the disease progresses, the tumor may grow larger and invade nearby tissues or spread to other parts of the body, such as the lungs, bones, or liver. The cancer cells can also enter the bloodstream or lymphatic system, facilitating further spread. Symptoms may include blood in the urine, a lump in the abdomen, or persistent pain in the side. The progression of the disease can vary, with some tumors growing slowly while others may advance more rapidly.

Trial ID:
2022-501251-81-00
Protocol code:
MK-3475-564
NCT ID:
NCT03142334
Trial Phase:
Therapeutic confirmatory (Phase III)

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