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Pembrolizumab + ADT for Prostate Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Willing to maintain continuous ADT with a LHRH agonists or antagonists during study treatment or have a history of bilateral orchiectomy

Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization

Must not have

Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Has had prior treatment with a next generation hormonal agent (eg, abiraterone, enzalutamide, apalutamide, darolutamide)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 59 months

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

Summary

This trial will test whether a combination of drugs is better than placebo at extending radiographic progression-free survival and overall survival for men with metastatic hormone-sensitive prostate cancer.

Who is the study for?

Men with advanced prostate cancer that has spread, who haven't had certain treatments like anti-PD-1 or anti-PD-L1 therapy. They must be able to perform daily activities with little help (ECOG status of 0 or 1), have good organ function, and agree to use contraception. Excluded are those with seizure history, vaccine within the last month, organ transplants, active autoimmune diseases needing recent treatment, significant heart issues or uncontrolled blood pressure.

What is being tested?

The trial is testing if adding pembrolizumab to enzalutamide and ADT improves survival without cancer growth compared to placebo plus enzalutamide and ADT in men with metastatic hormone-sensitive prostate cancer. The study was blinded but now all participants will receive standard care after stopping pembrolizumab/placebo.

What are the potential side effects?

Pembrolizumab can cause immune system-related side effects affecting various organs including lungs (pneumonitis), liver problems, skin reactions, hormonal gland changes leading to hormone deficiencies; also possible are infusion reactions and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to continue hormone therapy or have had both testicles removed.

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I have been on a stable dose of medication for bone health before joining the study.

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I am a male with a specific type of prostate cancer.

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My cancer has spread to my bones or organs, confirmed by scans.

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I agree to use a condom during any sexual activity.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active HIV, HBV, or HCV infection.

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I have been treated with advanced hormone therapy for cancer.

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I have a history of seizures or conditions that could lead to seizures.

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I have not had a recent heart attack or severe heart failure.

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I may have cancer spread to my brain or its coverings.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I've had hormone therapy for prostate cancer before it spread, for over 39 months or within the last 9 months, or my cancer got worse on hormone therapy.

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I have received an organ or tissue transplant from another person.

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I have a history of serious heart rhythm problems.

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I have not received a live vaccine in the last 30 days.

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I am currently being treated for an active infection.

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I have been treated with specific immune therapy for cancer.

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I have been treated for an autoimmune disease in the last 2 years.

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I have a condition that affects how my body absorbs food or I can't swallow pills.

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I am allergic to pembrolizumab, enzalutamide, or their ingredients.

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I have had pneumonitis treated with steroids or have it now.

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My blood pressure is either below 86 or above 170/105 mmHg.

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I have an immune system disorder or am on long-term steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 59 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 59 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 59 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Survival (OS)

Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

Secondary study objectives

Duration of Response (DOR) Per PCWG- Modified RECIST 1.1 as Assessed by BICR

Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

Number of Participants Who Experience an Adverse Event (AE)

+9 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab + Enzalutamide + ADTExperimental Treatment3 Interventions

Starting on Day 1 of each 21-day cycle, participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.

Group II: Placebo + Enzalutamide + ADTPlacebo Group3 Interventions

Starting on Day 1 of each 21-day cycle, participants receive placebo IV Q3W for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Androgen Deprivation Therapy (ADT)

2005

Completed Phase 3

~610

Enzalutamide

FDA approved

Pembrolizumab

FDA approved