Study of Pembrolizumab and Enzalutamide for Patients with Metastatic Castration-Resistant Prostate Cancer

3 1 1

What is this study about?

This clinical trial is focused on studying a type of prostate cancer known as Metastatic Castration-Resistant Prostate Cancer (mCRPC). This is a form of prostate cancer that continues to grow and spread even when the amount of male hormones in the body is reduced to very low levels. The study is testing a combination of two treatments: Pembrolizumab, also known by its code name MK-3475, and Enzalutamide. Pembrolizumab is a medication that helps the immune system fight cancer, while Enzalutamide is used to block the effects of male hormones that can promote cancer growth. The trial will compare the effects of these two drugs together against a combination of a placebo and Enzalutamide.

The purpose of the study is to see if the combination of Pembrolizumab and Enzalutamide can help patients live longer and slow down the progression of the cancer compared to the placebo and Enzalutamide. Participants in the study will receive either the combination of Pembrolizumab and Enzalutamide or the placebo and Enzalutamide. The study will monitor the participants over a period to assess their overall survival and the time it takes for the cancer to progress as seen on medical imaging tests.

Throughout the study, participants will receive regular check-ups and assessments to monitor their health and the effects of the treatment. The study aims to provide valuable information on the effectiveness of combining Pembrolizumab with Enzalutamide in treating this challenging form of prostate cancer. The trial is expected to continue until 2025, providing insights that could lead to improved treatment options for patients with mCRPC.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of pembrolizumab and enzalutamide, while the other group will receive a placebo with enzalutamide. A placebo is a substance with no active medication, used to compare the effects of the actual drug.

2 medication administration

If you are in the group receiving pembrolizumab, it will be administered as an intravenous infusion. This means the medication will be given through a vein in your arm. The dosage is 25 mg/mL, and the frequency and duration will be determined by the study team.

You will also take enzalutamide orally, which means you will swallow the medication in pill form. The dosage and frequency will be provided by the study team.

3 monitoring and assessments

Throughout the study, you will undergo regular monitoring and assessments to evaluate your health and the effects of the treatment. This may include blood tests, imaging scans like CT or MRI, and other evaluations as needed.

The study aims to compare overall survival and progression-free survival between the two groups. Progression-free survival refers to the length of time during and after treatment that the cancer does not get worse.

4 completion of the study

The study is expected to continue until February 28, 2025. Your participation may last until the study ends or until you and the study team decide it is best for you to stop.

After completing the study, you may have follow-up visits to monitor your health and gather additional information about the long-term effects of the treatment.

Who Can Join the Study?

  • Must have a confirmed diagnosis of adenocarcinoma of the prostate, which is a type of prostate cancer, without any small cell cancer features.
  • Prostate cancer must have progressed while on androgen deprivation therapy (a treatment to lower male hormones) or after surgical removal of the testicles, within 6 months before joining the study.
  • Must have current evidence of metastatic disease, meaning the cancer has spread to other parts of the body, shown by bone lesions on a bone scan or soft tissue disease on a CT or MRI scan.
  • Must be undergoing ongoing androgen deprivation therapy with serum testosterone levels less than 50 ng/dL (a measure of male hormone levels).
  • Only male participants are eligible for this study.

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 can participate in this study.
  • Patients who are part of a vulnerable population cannot participate. This means groups of people who might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
IRCCS Humanitas Research Hospital Rozzano Italy
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
Centre Hospitalier Regional Et Universitaire De Brest Brest France
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Hospital Universitario Hm Sanchinarro Madrid Spain
Centre Jean Perrin Clermont Ferrand France
Universitaetsmedizin Goettingen Goettingen Germany
Medical Center Haaglanden Hague The Netherlands
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland

Other Sites

Site Name City Country Status
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Del Mar Barcelona Spain
Provita Centrum Medyczne Sp. z o.o. Tomaszow Mazowiecki Poland
Amphia Hospital Breda The Netherlands
Hospital Universitari De Girona Doctor Josep Trueta Girona Spain
Centre Hospitalier De Saint-Quentin Saint Quentin France
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
University Hospital Limerick Limerick Ireland
Institut Sainte Catherine Avignon France
Centre Hospitalier De Valenciennes Valenciennes France
I Przychodnia Lekarska Komed Roman Karaszewski II Osrodek Badan Klinicznych III Restauracja Rogatka Roman Karaszewski Konin Poland
Krhlqvyc Nwjsrnhdi Nürnberg Germany
Bzkductr Hiaozosj Dublin Ireland
Vekucm dcg Rkfwf Uufocxfpgh Haormjck Sevilla Spain
Umacpabjogtztedvmeogh Tmpakocrc Anx Tuebingen Germany
Ajrmslihe Usm Amsterdam The Netherlands
Sroycvqoq Rugnnun Uyyehcbplm Mtxveyt Ceuhdp Nijmegen The Netherlands
Hesummrw Czfnppu Sxc Cagpxn Madrid Spain
Ucjmbiwaqfektyfcaeixt Mnnsivmj Atd Munster Germany
Ngxqgaqik Aosn Ncdp Jnasf aflp Novy Jicin Czechia
Mqnysfw Cbqgyu &uistrg Uclzmvhgbh Ow Fioyduyb Freiburg Im Breisgau Germany
Ckfidz Hlmummbrujo Uafdcjkeqtvbn Awboql Plyljtlf Amiens France
Ablaylb Uonpl Sqlxvyzwv Lbxzpd Dm Bkcrvjb Bologna Italy
Kynhqkii dno Tnnlbfwcvag Unpampsupmyz Mauvbydq (bay Kbwdydzba Munich Germany
Oymwflfrbmqfng Lfua Gfdn Linz Austria
Unwqbxlachqrztsbknfnj Swjdmfrnbukbarimkx Azp Kiel Germany
Chmimv Hqtybcbusvi Lzup Spp Pierre Benite France
Icunirtr Cshant Dgezzveecfdosduva L'hospitalet De Llobregat Spain
Ffzydetcr Inzvpdoor Vdilhmabzz Di Ogocjnsnk Valencia Spain
Celzyuq Omtmgwmxevc Clirat Psecdax Elks Plovdiv Bulgaria
Htpopbqb Uehvwxyjpcwfv Vrlsgc Dc La Vahzvcfs Malaga Spain
Ahoevzmugy Zpefigblmx Midhertkah Maastricht The Netherlands
Pqqk Tjgkl Hdhgbsan Umwhmxwnehjx Sabadell Spain
Ieskczos Rubbachu Dz Cuhcmd Dk Mhdfjardngz Montpellier France
Oujlnfwc Ohjgowlvqj Iaekfgk Budapest Hungary
Bgkerrzkwkw Vonjcfotr Ofnhcaosabju Kecskemet Hungary
Afl Nwjevt 2 Naqw &kxygql Ovnmknko Sdldl Mnihd dwuaj Goqkkt Pozzuoli Italy
Aurgiqhm Acx Mqhbk Hbhziybf Dublin Ireland
Munpwix Cllbdi Hfbtncgam Davfshh Fkuwzz Budapest Hungary
Cknzyp Hzzlrjurzgd Udnlvcgwsydul dknkvssvs Orléans France
Cwnepn Hkscjivkkmt Urnixrdusnsbl Do Nqwlyw Saint-Herblain France
Amalhsm Orhuqsyioaf Pit Lskzufaqujctdxdba Cqeokgpglv Catania Italy
Cptkznaby Znrjutltce Sfucibohw Eindhoven The Netherlands
Byuvfapk Utzikmzglg Hixtmjtz Cyeshu Besançon France
Hfcrcoev Udbjqklzxbkbn Qrokmwhmnzp Motjkr Pozuelo De Alarcon Spain
Fddnnzbv Nihjiehax U Sf Afhp V Blqx Brno-Stred Czechia
Sgan Ftnddzdvdm Vxbolzexl Gywje Sbnmozfkm Rotterdam The Netherlands
Gjeaeqbrgabgdgofm Vubsxugzf Pkrr Axwtjm Elqdezcj Oxfhdv Khemdr Gyor Hungary
Nqjsxbmgg Zubglyzydgkjqpe Sgfothhtn Alkmaar The Netherlands
Ctkmcux Ocimbtagt Ixz Pvomh Ffhzrynzwg Lqqnjevikan W Bpqqgffuec Bydgoszcz Poland
Hdqdhuno Ffye Suresnes France
Apalnmc Ooysiaavmyz S Mrroj Dj Tymou Terni Italy
Bbboqcosjil Biwefdh Txjhb ggxqz Trier Germany
Cztkgcu Rqnywznn Onbbacxgfvoz Ghud Berlin Germany
Tccernpuimjlowqppea Hilversum The Netherlands
Hjphgniy Szj Pehzu Du Aenxbomip Caceres Spain
Swnrnvueztpua Unsudfvb Srprt Fhjqbybqgz Mh Tnhlyo Titfymwgkzw Ml Par Gze Nuertingen Germany
Iaxpjsgi Mopdihvxtv Mdjcirdxmu Paris France
Iuqoviauzfs Dt Nastj Nancy France
Mz Adkbkpzw Chvstf Cxtoxz Madrid Spain
Zzzweycmadyvwox Tlismg Scryyggzs Almelo The Netherlands
Gsofgm Hleauyyffhy Snhme Vbpzswb STRASBOURG, Alsace 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
05.07.2019
Bulgaria Bulgaria
Not recruiting
05.07.2019
Czechia Czechia
Not recruiting
05.07.2019
France France
Not recruiting
05.07.2019
Germany Germany
Not recruiting
05.07.2019
Hungary Hungary
Not recruiting
05.07.2019
Ireland Ireland
Not recruiting
05.07.2019
Italy Italy
Not recruiting
05.07.2019
Poland Poland
Not recruiting
05.07.2019
Spain Spain
Not recruiting
05.07.2019
The Netherlands The Netherlands
Not recruiting
05.07.2019

Trial locations

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 improve survival in patients with a specific type of prostate cancer that has spread to other parts of the body and is resistant to standard hormone therapy.

Enzalutamide is a medication used to treat prostate cancer. It works by blocking the effects of male hormones that can promote the growth of cancer cells. In this trial, enzalutamide is used in combination with pembrolizumab to see if the two medications together can be more effective in treating prostate cancer than enzalutamide alone.

Metastatic Castration-Resistant Prostate Cancer – This is a type of prostate cancer that continues to grow and spread despite low levels of testosterone, which is typically achieved through medical or surgical castration. The disease is characterized by the cancer cells’ ability to thrive even when androgen levels are reduced to very low levels. It often spreads to bones, lymph nodes, and other parts of the body. As the cancer progresses, patients may experience symptoms such as bone pain, urinary issues, and fatigue. The progression of the disease is monitored through imaging studies and prostate-specific antigen (PSA) levels. Over time, the cancer may become more aggressive and resistant to standard therapies.

Trial ID:
2022-500785-10-00
Protocol code:
MK-3475-641
NCT ID:
NCT03834493
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Phase I/II Study of AZD6621 Safety and Efficacy in Adult Men with Metastatic Prostate Cancer

    Recruiting

    2 1 1
    Investigated Diseases:
    Belgium Italy The Netherlands Poland Spain
  • A study of JNJ-78278343 and docetaxel compared to docetaxel and prednisone in patients with metastatic castration-resistant prostate cancer

    Recruiting

    3 1 1 1
    Investigated Diseases:
    Investigated Drugs:
    Belgium France Germany Italy Spain