Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Prostate cancer drug combo trial halted early – no benefit seen

NCT ID NCT04934722

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study tested whether adding the immunotherapy drug pembrolizumab to standard hormone therapy (enzalutamide plus ADT) could help men with metastatic hormone-sensitive prostate cancer live longer or delay cancer growth. The trial enrolled 186 Chinese men and was stopped early because the combination did not show enough benefit. Participants stopped the study drug and were offered standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

186 people

The number who actually took part.

Started

May 2021

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology * Has metastatic disease assessed by investigator and verified by Blinded Independent Central Review (BICR) by either ≥2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI) * Willing to maintain continuous Androgen Deprivation Therapy (ADT) with a luteinizing-hormone releasing hormone (LHRH) agonists or antagonists during study treatment or have a history of bilateral orchiectomy * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization * Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization * Has adequate organ function * Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample * Male participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic * Male participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex Exclusion Criteria: * Has a known additional malignancy that is progressing or has required active treatment in the last 3 years * Has an active autoimmune disease that has required systemic treatment in past 2 years * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications * Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules * Has an active infection (including tuberculosis) requiring systemic therapy * Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis * Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection * Has known or suspected central nervous system (CNS) metastases and/or carcinomatous meningitis * Has a history of seizure or any condition that may predispose to seizure * Has a history of loss of consciousness within 12 months of screening * Has had myocardial infarction or uncontrolled angina within 6 months prior to randomization, or has New York Heart Association class III or IV congestive heart failure or a history of New York Heart Association class III or IV congestive heart failure * Has hypotension (systolic blood pressure \<86 millimeters of mercury \[mmHg\]) or uncontrolled hypertension (systolic blood pressure \>170 mmHg or diastolic blood pressure \>105 mmHg) at the screening visit * Has a history of clinically significant ventricular arrhythmias * Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients * Has received prior ADT as neoadjuvant/adjuvant therapy for non-metastatic prostate cancer for \>39 months in duration or within 9 months prior to randomization or with evidence of disease progression while receiving ADT * Has had prior treatment with a next generation hormonal agent (eg, abiraterone, enzalutamide, apalutamide, darolutamide) * Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-programmed cell death-ligand 2 (anti PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor * Has received a live vaccine within 30 days prior to randomization * Has a "superscan" bone scan * Has had an allogenic tissue/solid organ transplant * Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment * Has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer with the following exceptions: 1. Up to 3 months of ADT or orchiectomy with or without concurrent first-generation antiandrogens, if patient was not treated with docetaxel 2. May have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to randomization 3. For participants with low volume metastatic disease, may have 1 course of definitive radiotherapy if it was administered at least 4 weeks prior to randomization 4. Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of randomization and no evidence of disease progression. In these participants up to 6 months of ADT permitted

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Metastatic hormone sensitive prostate cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autosomal dominant Parkinson disease 4 metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic hormone sensitive prostate cancer

Contacts and locations

Locations

  • 2nd Affil Hosp of Zhejiang University College of Medicine ( Site 0808)

    Hangzhou, Zhejiang, 310009, China

  • Beijing Cancer Hospital ( Site 0802)

    Beijing, Beijing Municipality, 100142, China

  • Chongqing Cancer Hospital ( Site 0815)

    Chongqing, Chongqing Municipality, 400030, China

  • Harbin Medical University Cancer Hospital ( Site 0822)

    Harbin, Heilongjiang, 150081, China

  • Henan Cancer Hospital ( Site 0818)

    Zhengzhou, Henan, 450008, China

  • Hubei Cancer Hospital ( Site 0833)

    Wuhan, Hubei, 430079, China

  • Hunan Cancer Hospital ( Site 0817)

    Changsha, Hunan, 410013, China

  • Nanjing Drum Tower Hospital ( Site 0811)

    Nanjing, Jiangsu, 210008, China

  • Ningbo First Hospital-Urology (0835)

    Ningbo, Zhejiang, 315010, China

  • Peking University First Hospital ( Site 0800)

    Beijing, Beijing Municipality, 100034, China

  • Renji Hospital Shanghai Jiaotong University School of Medicine ( Site 0807 )

    Shanghai, Shanghai Municipality, 200127, China

  • Southern Medical University Nanfang Hospital ( Site 0838)

    Guangzhou, Guangdong, 510515, China

  • Sun Yat Sen Memorial Hospital (Site # 0819)

    Guangzhou, Guangdong, 510220, China

  • Sun Yat-Sen University Cancer Center ( Site 0825)

    Guangzhou, Guangdong, 510060, China

  • The 1st Affil Hosp of College of Medicine, Zhejiang Univ ( Site 0830)

    Hangzhou, Zhejiang, 310009, China

  • The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 0638)

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of Nanchang University ( Site 0821)

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 0834)

    Wenzhou, Zhejiang, 325000, China

  • The First Affiliated Hospital of Xiamen University (Site 0816)

    Xiamen, Fujian, 361000, China

  • The Second Affiliated Hosp of Xi'an Jiaotong Univ College of Medicine ( Site 0831)

    Xi'an, Shaanxi, 710004, China

  • The first affiliated Hospital of Xi an Jiaotong University ( Site # 0812)

    Xi’an, Shanxi, 710061, China

  • Tianjin Medical University Cancer Institute & Hospital ( Site 0804 )

    Tianjin, Tianjin Municipality, 300000, China

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0829)

    Wuhan, Hubei, 430000, China

  • Zhejiang Provincial People's Hospital ( Site 0809)

    Hangzhou, Zhejiang, 310014, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.