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Monoclonal Antibodies
Pembrolizumab for Prostate Cancer
Phase 2
Waitlist Available
Led By Julie Graff
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine =< 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]); creatinine clearance should be calculated per institutional standard, performed within 28 days of treatment initiation
International normalized ratio (INR) or prothrombin time (PT) =< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants (only if submitting to a biopsy), performed within 28 days of treatment initiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights
Study Summary
This trial studies pembrolizumab to treat prostate cancer that has spread and is still growing despite reduced testosterone. Pembrolizumab is a monoclonal antibody that may help to block tumor growth.
Who is the study for?
This trial is for men with prostate cancer that has spread and doesn't respond to low testosterone or enzalutamide treatment. They must have good blood counts, liver and kidney function, be willing to use contraception, and not have had certain other treatments recently.Check my eligibility
What is being tested?
The study tests pembrolizumab's effectiveness in patients whose prostate cancer continues to grow after enzalutamide treatment. Pembrolizumab is a monoclonal antibody designed to block tumor growth by targeting specific cells.See study design
What are the potential side effects?
Pembrolizumab may cause immune system reactions affecting organs, fatigue, infusion-related symptoms, skin rashes, digestive issues like diarrhea or constipation, hormone gland problems (like thyroid), and can increase infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is within the required range for the study.
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My blood clotting time is normal or managed if I'm on blood thinners.
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My blood clotting time is normal or managed if I'm on blood thinners.
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My prostate cancer is confirmed and not purely small cell type.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My prostate cancer has worsened on enzalutamide, shown by PSA or scans.
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I have had surgical castration or am on hormone therapy to lower my testosterone and will continue it during the study.
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My liver function tests are within the required limits.
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I can provide a sample of my previous biopsy.
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My white blood cell count is high enough for treatment.
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My bilirubin levels are within the normal range.
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My cancer has spread to other parts of my body.
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I have a cancer spread that can be sampled through a biopsy.
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My prostate cancer is spreading and no longer responds to enzalutamide.
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I agree to use birth control during and for 4 months after the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PSA response, defined by a PSA decrease of at least 50% confirmed by a second measurement at least 3 weeks later
Secondary outcome measures
Changes in T cell activation as measured in whole blood
Changes in T cell numbers as measured in whole blood
Changes in T cell phenotype as measured in whole blood
+9 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment3 Interventions
INITIAL TREATMENT PHASE: Patients who are progressing on enzalutamide will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily.
MONITORING PHASE: After completion of the initial treatment phase, patients continue to receive standard of care enzalutamide PO daily for the duration of the trial.
RETREATMENT PHASE: Patients with disease response or stability after the initial treatment phase will receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for an additional 4 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive standard of care enzalutamide PO daily for the duration of the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950
Enzalutamide
2014
Completed Phase 4
~2760
Find a Location
Who is running the clinical trial?
Collins Medical TrustOTHER
4 Previous Clinical Trials
207 Total Patients Enrolled
Oregon Health and Science UniversityOTHER
966 Previous Clinical Trials
6,845,693 Total Patients Enrolled
21 Trials studying Prostate Cancer
7,376 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,860 Previous Clinical Trials
5,047,796 Total Patients Enrolled
27 Trials studying Prostate Cancer
16,997 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with HIV.My kidney function is within the required range for the study.My blood clotting time is normal or managed if I'm on blood thinners.I do not have an active severe autoimmune disease needing strong treatment in the last 3 months.My cancer is quickly worsening, and my doctor thinks docetaxel could help.My prostate cancer is confirmed and not purely small cell type.I am fully active or restricted in physically strenuous activity but can do light work.I haven't taken any monoclonal antibody or denosumab in the last 4 weeks.I have fully recovered from any major surgery before starting treatment.I've had chemotherapy for cancer that didn't respond to hormone therapy.I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.I have not received a live vaccine in the last 30 days.I have another cancer, but it's either not growing or doesn't need treatment, except for certain skin cancers or bladder cancer that's been treated.I have cancer that has spread to my brain or its coverings.I have been treated with specific immune-targeting drugs before.My blood clotting time is normal or managed if I'm on blood thinners.My prostate cancer has worsened on enzalutamide, shown by PSA or scans.I have had surgical castration or am on hormone therapy to lower my testosterone and will continue it during the study.My liver function tests are within the required limits.I have mild to moderate nerve damage.I have had pneumonitis treated with steroids or have it now.I plan to receive specific cancer treatments during the study.I can provide a sample of my previous biopsy.My white blood cell count is high enough for treatment.My bilirubin levels are within the normal range.My cancer has spread to other parts of my body.I have a cancer spread that can be sampled through a biopsy.My prostate cancer is spreading and no longer responds to enzalutamide.I have had seizures in the past.I am currently being treated for an infection with medication.I agree to use birth control during and for 4 months after the study.I am not on steroids or immunosuppressants, or only on low-dose steroids as approved.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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