Your session is about to expire
← Back to Search
Virus Therapy
177Lu-PSMA-617 + Pembrolizumab for Prostate Cancer
Phase 1
Waitlist Available
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
Patients willing to undergo tumor biopsy and have at least one lesion safely accessible to tumor biopsy. Bone or soft tissue lesion is allowed
Castrate level of serum testosterone at study entry (< 50 ng/dL). Patients without prior bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analogue treatment for duration of study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a combination of two drugs to treat prostate cancer that has spread. The first drug, 177Lu-PSMA-617, is a radioactive agent that targets and kills cancer cells. The second drug, pembrolizumab, is an immunotherapy that helps the body's immune system attack the cancer. The combination of these two drugs may be more effective at treating prostate cancer than either drug alone.
Who is the study for?
This trial is for patients with metastatic castration-resistant prostate cancer who've progressed after treatment with androgen signaling inhibitors. They must have good blood counts, organ function, agree to contraception, and not have untreated brain metastases or certain other health conditions.Check my eligibility
What is being tested?
The study tests a combination of 177Lu-PSMA-617 (a radioactive drug targeting prostate cancer cells) and pembrolizumab (an immunotherapy). It aims to find the best dose and schedule for treating advanced prostate cancer by enhancing the body's immune response against tumors.See study design
What are the potential side effects?
Possible side effects include reactions related to radiation exposure from 177Lu-PSMA-617, as well as typical immunotherapy-related issues like inflammation in organs due to pembrolizumab. Patients may also experience fatigue, blood count changes, and increased infection risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to have a tumor biopsy and have at least one tumor that can be safely biopsied.
Select...
My testosterone levels are very low, and I am on or will continue hormone therapy if I haven't had surgery to remove my testicles.
Select...
My cancer progressed after treatment with a specific hormone therapy.
Select...
My prostate cancer is worsening despite hormone therapy.
Select...
My PET scan shows at least three lesions more active than my liver.
Select...
I am fully active or have some restrictions but can still care for myself.
Select...
My kidney function, measured by creatinine or GFR, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR) (Part B)
Recommended phase 2 dose (Part A)
Secondary outcome measures
Median Overall Survival (OS)
Median PSA progression-free survival
Median duration of response
+4 moreOther outcome measures
Lesion-specific response rate by baseline PSMA avidity on gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) positron emission tomography (PET)
Percent change in T cell repertoire, circulating T cell subsets, tumor infiltrating lymphocytes (TILs), and tumor PD-L1 expression by immunohistochemistry
Trial Design
3Treatment groups
Experimental Treatment
Group I: Schedule 3 (lutetium Lu 177-PSMA-617, pembrolizumab)Experimental Treatment2 Interventions
Starting day -21, patients receive pembrolizumab IV over 30 minutes. Patients also receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Group II: Schedule 2 (lutetium Lu 177-PSMA-617, pembrolizumab)Experimental Treatment2 Interventions
Patients receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes and pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Group III: Schedule 1 (lutetium Lu 177-PSMA-617, pembrolizumab)Experimental Treatment2 Interventions
Patients receive lutetium Lu 177-PSMA-617 IV over 20-30 minutes on day 1. Beginning in cycle 2, patients receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients who achieve SD or better may receive 17 additional cycles (approximately 1 year) of pembrolizumab.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,517 Previous Clinical Trials
15,240,986 Total Patients Enrolled
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,737 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,321 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had radiotherapy over 2 weeks ago, with no ongoing side effects and didn't need steroids.If you have had a procedure called vasectomy, which prevents pregnancy, you will still be considered capable of having children for this study.I have a history of hepatitis B or active hepatitis C.I have previously received treatment targeting PSMA.I have a bleeding disorder but am not on blood thinners that can't be stopped for a biopsy.I have brain metastases that have not been treated.I have had radiation on more than 25% of my bone marrow or within the last 14 days.I am unable to give informed consent due to my age or health condition.I have previously received treatments like pembrolizumab or other immune checkpoint inhibitors.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I haven't had a heart attack, unstable chest pain, or stroke in the last 6 months.I am willing to have a tumor biopsy and have at least one tumor that can be safely biopsied.My testosterone levels are very low, and I am on or will continue hormone therapy if I haven't had surgery to remove my testicles.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I haven't needed steroids for 2 weeks before starting the study treatment.I will use birth control during and for 60 days after the study.My last treatment was more than 28 days ago.My cancer progressed after treatment with a specific hormone therapy.I have not received a live vaccine within the last 30 days.I do not have serious heart problems.I have had serious lung inflammation in the past 2 years or have it now.I have recovered from any major surgery before starting the study treatment.You have recently been in another research study or used an experimental treatment within the last 4 weeks.I do not have severe numbness, pain, or weakness in my hands or feet.My prostate cancer is worsening despite hormone therapy.You have a severe allergic reaction (grade 3 or higher) to pembrolizumab or any of its ingredients.I am currently being treated for an infection.I have been diagnosed with prostate cancer, not the small cell neuroendocrine type.My PET scan shows at least three lesions more active than my liver.My partner can potentially become pregnant.I haven't had cancer treatments except for LHRH analogues in the last 14 days or 5 half-lives, whichever is shorter. Any side effects from past treatments are mild.I have an active TB infection.I have received taxane chemotherapy for hormone-resistant cancer.I have not had major surgery in the last 4 weeks.I have severe heart failure that is not well-managed.I am fully active or have some restrictions but can still care for myself.My kidney function, measured by creatinine or GFR, is within the normal range.I have received radium-223 or similar treatments for prostate cancer.My heart rhythm problem is not controlled by medication, but I don't have chronic or occasional atrial fibrillation/flutter.
Research Study Groups:
This trial has the following groups:- Group 1: Schedule 2 (lutetium Lu 177-PSMA-617, pembrolizumab)
- Group 2: Schedule 3 (lutetium Lu 177-PSMA-617, pembrolizumab)
- Group 3: Schedule 1 (lutetium Lu 177-PSMA-617, 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.
Share this study with friends
Copy Link
Messenger