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Pembrolizumab + ADT for Prostate Cancer
Study 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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
Media Library
- I have an active HIV, HBV, or HCV infection.I have been treated with advanced hormone therapy for cancer.I have a history of seizures or conditions that could lead to seizures.I have a recent biopsy from a non-irradiated area or from a tumor in a previously radiated area.I am willing to continue hormone therapy or have had both testicles removed.I have not had a recent heart attack or severe heart failure.My organs are functioning well.I had major surgery, excluding prostate biopsy, within the last 28 days and haven't fully recovered.I may have cancer spread to my brain or its coverings.I've had limited treatment for my metastatic prostate cancer, following specific guidelines.I am a male and agree to not donate sperm and either abstain from sex or use contraception for 120 days after the last dose.My cancer has spread to my bones or organs, confirmed by scans.I have another cancer that is getting worse or was treated in the last 3 years.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.You have fainted or lost consciousness within the past year.I have been on a stable dose of medication for bone health before joining the study.I am a male with a specific type of prostate cancer.I have received an organ or tissue transplant from another person.I have a history of serious heart rhythm problems.I have not received a live vaccine in the last 30 days.I agree to use a condom during any sexual activity.I am currently being treated for an active infection.I have been treated with specific immune therapy for cancer.I have been treated for an autoimmune disease in the last 2 years.I have a condition that affects how my body absorbs food or I can't swallow pills.I am fully active or restricted in physically strenuous activity but can do light work.I am allergic to pembrolizumab, enzalutamide, or their ingredients.I have had pneumonitis treated with steroids or have it now.My blood pressure is either below 86 or above 170/105 mmHg.I have an immune system disorder or am on long-term steroids.
- Group 1: Placebo + Enzalutamide + ADT
- Group 2: Pembrolizumab + Enzalutamide + ADT
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Pembrolizumab received regulatory approval from the FDA?
"Pembrolizumab has received a 3 for safety. This is due to this being a Phase 3 trial, where there is some efficacy data and multiple rounds of safety data."
Which hospitals are conducting this research project at the moment?
"33 clinical trial sites are currently recruiting patients for this study. While Billings, Fairfax and Durham are some of the locations, there are 30 other sites where patients can be enrolled. To minimize the burden of travel, patients should select the location nearest to them."
What medical conditions does Pembrolizumab typically treat?
"Pembrolizumab is a medication that can be used to treat various cancers, including those that are considered inoperable. It can also be helpful for patients with microsatellite instability high or those that have seen disease progression after chemotherapy."
What is the total number of individuals taking part in this experiment?
"This particular clinical trial is no longer recruiting patients. Although, according to the latest data, there are 1507 trials actively recruiting participants with prostate cancer and 1092 trials for Pembrolizumab."
What other Pembrolizumab research is currently being conducted?
"Pembrolizumab was first studied in 2005 at the Edinburgh Cancer Centre. As of now, there have been 18,559 completed clinical trials. Out of these, 1,092 are actively recruiting patients. These trials are being conducted in various locations, with a significant number taking place in Billings, Montana."
Are there still open positions for trial volunteers?
"This particular trial is not currently looking for patients, according to the latest update on clinicaltrials.gov. The trial was first posted on February 12th, 2020 and was last edited on August 18th, 2020. If you are looking for other studies, there are presently 1507 trials actively searching for participants with prostate cancer and 1092 studies for Pembrolizumab actively recruiting patients."
What are the chief goals of this scientific experiment?
"The sponsor of this study, Merck Sharp & Dohme Corp., has stated that the primary objective of this clinical trial will be to measure Overall Survival (OS) over the course of Up to approximately 77 months. Additionally, this trial will be assessing secondary outcomes including Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST), Prostate-specific antigen (PSA) Undetectable Rate, and Time to Prostate-specific Antigen (PSA) Progression."
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