Study of Pembrolizumab, Vibostolimab, and Belzutifan for Patients with Metastatic Castration-Resistant Prostate Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Metastatic Castration-Resistant Prostate Cancer, a type of prostate cancer that continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. The study is testing a combination of therapies that include Pembrolizumab (also known as MK-3475), which is a type of immunotherapy that helps the immune system fight cancer. Other medications being studied in combination with Pembrolizumab include Abiraterone, Enzalutamide, Docetaxel, Carboplatin, Etoposide, Olaparib, Lenvatinib, and Belzutifan. Some of these medications are given as tablets, while others are administered through an infusion into a vein.

The purpose of this study is to evaluate the safety and effectiveness of these combination therapies. Participants will receive either the combination therapy or a placebo. The study will monitor the participants’ response to the treatment, including any changes in their prostate-specific antigen (PSA) levels, which is a marker used to track prostate cancer. The study will also look at how long the participants live and how long they respond to the treatment. Participants will be closely monitored for any side effects or adverse events during the study.

The study will take place over several years, with participants receiving treatment and being monitored regularly. The goal is to find out if these combination therapies can help control the cancer and improve the quality of life for those affected by this type of prostate cancer. The study will provide valuable information that could lead to new treatment options for patients with metastatic castration-resistant prostate cancer.

1 joining the study

Upon joining the study, the participant will be assigned to a specific cohort based on their medical history and previous treatments for metastatic castration-resistant prostate cancer (mCRPC).

2 initial assessment

An initial assessment will be conducted to evaluate the participant’s current health status and eligibility for the trial. This includes providing tumor tissue samples and confirming ongoing prostate cancer progression.

3 treatment administration

Participants will receive a combination of medications, which may include pembrolizumab, vibostolimab, abiraterone, enzalutamide, docetaxel, carboplatin, etoposide, olaparib, lenvatinib, belzutifan, prednisolone, and dexamethasone. The administration route varies, including oral use and intravenous infusion, depending on the specific medication.

4 monitoring and follow-up

Regular monitoring will be conducted to assess the safety and effectiveness of the treatment. This includes tracking the prostate-specific antigen (PSA) levels and any adverse events experienced by the participant.

5 completion of treatment

The treatment phase will continue until the participant completes the study or if any adverse events necessitate discontinuation. The estimated end date for the trial is October 22, 2027.

6 final evaluation

A final evaluation will be conducted to determine the overall response to the treatment, including the objective response rate and any changes in disease progression.

Who Can Join the Study?

  • Must have metastatic castration-resistant prostate cancer. This means the cancer has spread to other parts of the body and is not responding to treatments that lower testosterone.
  • Must be male.
  • Must be able to provide a sample of tumor tissue from a site that has not been treated with radiation.
  • Must have cancer progression within 6 months before screening, as determined by the doctor, using specific criteria like rising PSA levels or new bone lesions.
  • Must have ongoing treatment to lower testosterone levels, with specific hormone treatments started at least 4 weeks before the study and continued throughout the study.
  • If receiving bone-strengthening therapy, must be on stable doses for at least 4 weeks before the study.
  • Must agree to use contraception or be abstinent from heterosexual intercourse during the study and for a specific time after the last dose of study medication, unless confirmed to be unable to produce sperm.
  • Must have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale for certain groups. This scale measures how well you can perform daily activities.
  • Must have received specific prior treatments depending on the cohort, such as certain chemotherapy or hormonal therapies.

Who Cannot Join the Study?

  • Patients who do not have Metastatic Castration-Resistant Prostate Cancer cannot participate. This is a type of prostate cancer that has spread to other parts of the body and does not respond to treatments that lower testosterone.
  • Only male patients are eligible for this study.
  • Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not eligible.

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
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Medical University Of Vienna Vienna Austria
Oncopole Claudius Regaud Toulouse France

Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Staedtisches Klinikum Braunschweig gGmbH Brunswick Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario 12 De Octubre Madrid Spain
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany
SCRI CCCIT Ges.m.b.H. Salzburg Austria
Region Skane Skanes Universitetssjukhus Lund Sweden
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Karolinska University Hospital Solna Sweden
Stichting Radboud University Medical Center Nijmegen The Netherlands
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Rigshospitalet Copenhagen Denmark
Pirkanmaan hyvinvointialue Tampere Finland
Netherlands Cancer Institute Amsterdam The Netherlands
Hopital Beaujon Clichy France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Soedersjukhuset AB Stockholm Sweden
Ukitppyvwk Mnfcqqv Crmnlv Hxpcqohjlujvcrfrw Hamburg Germany
Upcrjooyjlxtcfwzrpxrm Esegc Anh Essen Germany
Ozrzyknxfjpbti Lpah Gcoi Linz Austria
Iwvvrgjb Clhhgq Dvojfelebdyuotblz L'hospitalet De Llobregat Spain
Hahgsf Hyabvlks Herlev Denmark
Epkkygj Uoupedrejagk Mfntpdp Chicadp Rilfkbfnf (gywwagb Mgt Rotterdam The Netherlands
Ucbxkbhlyjlsczugmaheg Mnagnvbo Aof Munster Germany
Npwcmejh Ixtendwa Ogagfymss Ihl Morpy Swmlinrnkpycoctpbegvlxtvvkid Ikwlyrmu Bhmxxbad Cracow Poland
Heiluoei Vgvn dgvjervn Barcelona Spain
Ixhemrhh Potryixdumdwskf Cdalxy Cdtnce Marseille France
Wrurbhjbwu Sowdxef Iyp Swjtieu Pff W Pbwgaipxe Przemysl Poland
Iaawzohv Chvbg Paris France

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
23.12.2016
Denmark Denmark
Recruiting
23.12.2016
Finland Finland
Not recruiting
23.12.2016
France France
Recruiting
23.12.2016
Germany Germany
Recruiting
23.12.2016
Ireland Ireland
Recruiting
23.12.2016
Italy Italy
Recruiting
23.12.2016
Poland Poland
Recruiting
23.12.2016
Spain Spain
Recruiting
23.12.2016
Sweden Sweden
Recruiting
23.12.2016
The Netherlands The Netherlands
Recruiting
23.12.2016

Trial locations

Pembrolizumab (MK-3475) is a medication used in this trial to treat metastatic castration-resistant prostate cancer. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is often used in combination with other therapies to enhance its effectiveness in fighting cancer.

Investigated diseases:

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread to other parts of the body despite treatments that lower testosterone levels. It is characterized by the cancer’s ability to resist hormonal therapy, which is typically used to slow its progression. The disease often spreads to bones, lymph nodes, and other organs, leading to various symptoms depending on the areas affected. Patients may experience increased levels of prostate-specific antigen (PSA) in the blood, which is a marker used to monitor the disease’s activity. Over time, the cancer may cause pain, urinary issues, and other complications as it progresses.

Trial ID:
2023-506987-15-00
Protocol code:
MK-3475-365
NCT ID:
NCT02861573
Trial Phase:
Human Pharmacology (Phase I) – Other

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