← 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 below
Select...
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...
I will use birth control during and for 60 days after the study.
Select...
My cancer progressed after treatment with a specific hormone therapy.
Select...
My prostate cancer is worsening despite hormone therapy.
Select...
I have been diagnosed with prostate cancer, not the small cell neuroendocrine type.
Select...
My PET scan shows at least three lesions more active than my liver.
Select...
My partner can potentially become pregnant.
Select...
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.
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 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

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 more
Other 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
~1950

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,755 Total Patients Enrolled
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,737 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,603 Total Patients Enrolled

Media Library

Lutetium Lu 177-PSMA-617 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03805594 — Phase 1
Prostate Adenocarcinoma Research Study Groups: Schedule 2 (lutetium Lu 177-PSMA-617, pembrolizumab), Schedule 3 (lutetium Lu 177-PSMA-617, pembrolizumab), Schedule 1 (lutetium Lu 177-PSMA-617, pembrolizumab)
Prostate Adenocarcinoma Clinical Trial 2023: Lutetium Lu 177-PSMA-617 Highlights & Side Effects. Trial Name: NCT03805594 — Phase 1
Lutetium Lu 177-PSMA-617 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03805594 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the intended outcome of this experiment?

"The primary goal of this clinical trial is to determine the recommended phase 2 dose, and it will be measured from the beginning of treatment up until disease progression or recurrence. Secondary objectives include estimating median PSA progression-free survival rate using Kaplan Meier Method; determining radiographic progression-free survival (rPFS) rate by RECIST version 1.1 Prostate cancer Working Group (PCWG)3 criteria; and assessing frequency/severity of adverse events according to CTCAE version 4.0 standards."

Answered by AI

Are there any accessible positions left in this research trial for individuals?

"At this stage, enrollment for the trial has closed. Initially posted on May 10th 2019 and last updated April 11th 2022, the study is no longer searching for participants. If you are seeking other opportunities to take part in research studies involving carcinoma or pembrolizumab treatments, there are currently 3680 and 992 trials respectively that require volunteers."

Answered by AI

Are there any prior instances of Pembrolizumab being used in clinical trials?

"Presently, there are 992 Pembrolizumab trials ongoing with 125 in the third stage of development. Houston is at the centre of most research endeavours for this medication but it can be accessed from 36009 other locations as well."

Answered by AI

Has the Federal Drug Administration acknowledged Pembrolizumab?

"The safety of pembrolizumab has been evaluated at a level 1, since this is an early-stage trial and limited evidence exists to support its efficacy or safety."

Answered by AI

What is the scope of enrollment for this research endeavor?

"Unfortunately, enrollment for this medical trial has temporarily closed. It was initially posted on May 10th 2019 and underwent its last revision on April 11th 2022. If you're still seeking clinical trials, there are currently 3680 studies involving carcinoma that are accepting participants and 992 research projects utilizing Pembrolizumab actively enrolling patients."

Answered by AI

In what circumstances is Pembrolizumab usually recommended?

"Pembrolizumab is commonly employed to battle malignant neoplasms, as well as other medical ailments such as microsatellite instability high, unresectable melanoma and post-chemotherapy disease progression."

Answered by AI
~7 spots leftby Mar 2025