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Checkpoint Inhibitor
Immunotherapy + Radiation ± PARP Inhibitor for Prostate Cancer
Phase 2
Recruiting
Led By Zin W Myint, MD
Research Sponsored by Zin W Myint
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will evaluate whether immunotherapy and radiation with or without a PARP-inhibitor will increase the effects of immunotherapy in men with high-risk localized prostate cancer.
Who is the study for?
Men with high-risk localized prostate cancer who meet specific health criteria can join this trial. They must have a certain level of physical fitness, no large pelvic nodes as per CT scans, and agree to use contraception post-treatment. Those with PSA levels over 150ng/ml, extensive prior hormone therapy or radiation to the prostate, other cancers within 2 years, or recent anti-cancer treatments cannot participate.
What is being tested?
The study is testing if combining Pembrolizumab (an immunotherapy drug) and radiation therapy improves treatment outcomes in these patients. Some will also receive Olaparib (a PARP-inhibitor) to see if it boosts the immune system's response when added to the mix.
What are the potential side effects?
Possible side effects include fatigue, skin reactions from radiation, immune-related conditions like inflammation in organs due to Pembrolizumab, and gastrointestinal issues or blood cell changes from Olaparib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Clinical Response Rate
Secondary study objectives
Biochemical-Free Survival
Metastasis-Free Survival
Molecular Alterations in Homologous Recombination Repair Genes
+1 moreOther study objectives
Cytokine
Correlation between clinical outcome and immune cell subtype.
Correlation between clinical outcomes and TCR repertories clonotypes.
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2 - PembrolizumabExperimental Treatment3 Interventions
Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab.
Group II: Arm 1 - Pembrolizumab and OlaparibExperimental Treatment4 Interventions
Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab and Olaparib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Olaparib
2007
Completed Phase 4
~2190
Androgen Deprivation Therapy
2008
Completed Phase 2
~110
Radiation Therapy
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,374 Total Patients Enrolled
27 Trials studying Prostate Cancer
17,430 Patients Enrolled for Prostate Cancer
Zin W MyintLead Sponsor
2 Previous Clinical Trials
51 Total Patients Enrolled
2 Trials studying Prostate Cancer
51 Patients Enrolled for Prostate Cancer
Zin W Myint, MDPrincipal InvestigatorUniversity of Kentucky
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My pelvic nodes are not larger than 2 cm as shown by a CT scan.I have had radiation treatment on my prostate before.I am fully active or can carry out light work.My organs and bone marrow are working well.I have been on hormone therapy for prostate cancer for over 90 days.I have a history of ulcerative proctitis.I have had major pelvic surgery or radiation therapy before.I haven't had any cancer treatment or experimental drugs in the last 4 weeks.My cancer has spread to distant parts of my body.My condition is considered high-risk according to NCCN guidelines.I stopped taking medication for prostate enlargement at least 60 days ago.I am a man diagnosed with prostate cancer.I started hormone therapy for prostate cancer less than 90 days ago.I have not had another type of cancer in the last 2 years.I have a heart condition or have been treated with heart-affecting drugs and need a heart function assessment.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 - Pembrolizumab and Olaparib
- Group 2: Arm 2 - Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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