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Radiopharmaceutical
Pembrolizumab + 177Lu-PSMA-617 for Prostate Cancer
Phase 2
Recruiting
Led By Rahul Aggarwal, 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 5 years
Awards & highlights
Study Summary
This trial studies a new therapy for metastatic prostate cancer, combining a targeted radiation and an immunotherapy drug.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, who've had prior treatment fail. They must understand the trial and agree in writing, have a low testosterone level, recovered from past treatments' side effects, no recent vaccines or major surgeries, no severe allergies to pembrolizumab or its ingredients, not on high-dose steroids or immunosuppressants, and be willing to follow safety guidelines.Check my eligibility
What is being tested?
The study is testing a combination of Pembrolizumab (an immune system booster) with a radioactive drug called 177Lu-PSMA-617 targeting prostate cancer cells. It's for patients whose cancer worsened after treatments like abiraterone. The goal is to see if this combo helps when standard therapies don't work anymore.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in organs like lungs (pneumonitis), fatigue, skin issues; plus risks associated with radiation including nausea and bone marrow suppression which can lead to anemia or infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median radiographic progression-free survival (rPFS) at 12 months
Secondary outcome measures
Median duration of objective response (DOR)
Median overall survival (OS)
Median time to PSA progression (TTPP1) following the first dose of 177Lu-PSMA-617
+22 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab, 177Lu-PSMA-617Experimental Treatment2 Interventions
Participants will receive an infusion of 7.4 gigabequerel (GBq) (+/- 10%) of 177Lu-PSMA-617 on Cycle 1 Day 1 (of a 28 day cycle), and at every PSA progression for up to a maximum of 6 doses. Beginning Cycle 2 Day 1 (Day 29), participants will receive 400 mg of Pembrolizumab every 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
177Lu-PSMA-617
2018
Completed Phase 3
~840
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,506 Previous Clinical Trials
15,238,507 Total Patients Enrolled
51 Trials studying Prostate Cancer
16,985 Patients Enrolled for Prostate Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,623 Total Patients Enrolled
26 Trials studying Prostate Cancer
16,949 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,732 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,882 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.My testosterone levels are very low (< 50 ng/dL) as required.I have had brain metastases treated and meet specific criteria.I have been treated with specific immune therapy for cancer.I have brain metastases that have not been treated.My side effects from previous cancer treatments are mild, except for hair loss or mild nerve pain.I haven't needed IV antibiotics for an infection in the last 7 days.My prostate cancer is not the small cell neuroendocrine type from the start.I have had serious lung inflammation needing steroids in the last 2 years or have it now.My CT scan shows soft tissue lesions, but they did not light up on the PSMA PET scan.I have had more than two rounds of chemotherapy with drugs from the taxane family.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have had taxane chemotherapy before or cannot have it for health reasons or personal choice.I have not received a live vaccine within the last 30 days.I haven't had radiation on more than 25% of my bone marrow or within the last 14 days.I am a man aged 18 or older.I have an active TB infection.I have a bleeding disorder and cannot stop my blood thinner safely for a biopsy.My prostate cancer is spreading and resistant to hormone therapy.My cancer progressed after treatment with drugs like abiraterone.I haven't had cancer treatment in the last 14 days, except for LHRH analogues.I have a serious heart condition.I had radiotherapy over 2 weeks ago, have no side effects, and didn't have radiation to the brain.I have another cancer, but it won't affect this trial's treatment.I have not had major surgery in the last 28 days or have fully recovered if I did.I will use effective birth control during and for 6 months after the study.I am willing to have a tumor biopsy and have at least one tumor that can be safely biopsied.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I am unable to give informed consent due to my age, health, or mental condition.I am mostly self-sufficient and can carry out daily activities.My screening shows at least one cancer spot with higher PSMA levels than normal liver tissue.I have previously received treatment targeting PSMA.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab, 177Lu-PSMA-617
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are recruitment efforts for this trial ongoing?
"Clinicaltrials.gov confirms that this medical trial, posted on April 30th 2023 and last updated March 1st of the same year, is not currently recruiting patients. There are however 1326 other studies actively accepting patient applications at present time."
Answered by AI
How have patients responded to the administration of Pembrolizumab, 177Lu-PSMA-617 in terms of safety?
"Based on the info we have, Pembrolizumab and 177Lu-PSMA-617 scored a 2 in terms of safety. This is because this particular trial is still in its second phase with data only available to support its security rather than efficacy."
Answered by AI
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