KEYNOTE-991 : A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Male<br/>OnlyGender Male
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Prostate<br/>CancersCancer LocationProstate
Cancers

Systemic therapy | Urinary systemProstate

Trial Overview Read MoreRead more

This phase III trial is trying to understand the safety and effectiveness of using an immunotherapy (pembrolizumab) and hormone therapy (Enzalutamide plus androgen deprivation therapy) to treat patients with metastatic hormone sensitive prostate cancer (mHSPC).
 

This trial is treating patients with metastatic hormone sensitive prostate cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Commercial Sponsor

Merck

Summary

Eligible patients will be randomised to receive intravenous pembrolizumab OR a placebo every 3 weeks for up to 35 cycles (approximately 2 years), plus oral enzalutamide once daily, while maintaining ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Genitourinary Research Study Coordinator
gu.oncresearch@monashhealth.org
0436387664

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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