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PD-L1 Inhibitor
Pembrolizumab for Prostate Cancer
Phase 2
Waitlist Available
Led By Lawrence Fong, MD
Research Sponsored by University of California, San Francisco
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 up to 24 months
Awards & highlights
Study Summary
This trial is testing a new drug to treat prostate cancer that has spread and is resistant to hormone therapy. The drug targets a protein made by some tumors with DNA damage.
Eligible Conditions
- Prostate Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic progression-free survival (rPFS).
Secondary outcome measures
Frequency of treatment-related adverse events for pembrolizumab
Progression-free survival (PFS)
Proportion of subjects achieving any PSA decline ≥ 50%
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: DNA damage repair proficient groupExperimental Treatment2 Interventions
Twenty-five subjects with mismatch repair (MMR) intact
Group II: DNA damage repair defective groupExperimental Treatment2 Interventions
Twenty-five subjects with defective DNA repair
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Chemotherapy
2003
Completed Phase 4
~3050
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,518 Previous Clinical Trials
15,241,703 Total Patients Enrolled
52 Trials studying Prostate Cancer
17,033 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,907 Previous Clinical Trials
5,066,070 Total Patients Enrolled
28 Trials studying Prostate Cancer
17,397 Patients Enrolled for Prostate Cancer
Lawrence Fong, MDPrincipal InvestigatorUniversity of California, San Francisco
10 Previous Clinical Trials
274 Total Patients Enrolled
4 Trials studying Prostate Cancer
142 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your testosterone levels must remain low during the study.You are not taking more than 10mg/day of prednisone for 7 days before starting treatment.You have a history of lung disease that required treatment with steroids or currently have lung disease.You have mental health or drug abuse problems that may make it difficult for you to follow the study's requirements.You must be 18 years old or older when signing the consent form.You must be willing and able to sign a paper saying that you agree to be in the study.You have already received treatment with abiraterone, enzalutamide, or apalutamide for your condition.You can participate in the study even if you have received treatment with sipuleucel-T, radium-223, or olaparib before.Your bone disease is getting worse according to a medical guideline called PCWG3.You have been diagnosed with a specific type of prostate cancer called adenocarcinoma.You have advanced prostate cancer with very low levels of testosterone.You have high levels of PSA in your blood that have been consistently increasing over time.Your soft tissues have grown according to a specific set of measurement guidelines called RECIST v1.1.You are currently receiving or have received an experimental treatment or used an experimental device within the last 4 weeks.You have an ongoing autoimmune disease that needed treatment within the last two years.
Research Study Groups:
This trial has the following groups:- Group 1: DNA damage repair proficient group
- Group 2: DNA damage repair defective group
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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