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NCT03805594 · ClinicalTrials.gov registry record · Phase 1
177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03805594: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT03805594 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03805594, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This phase Ib trial studies the dose and schedule of 177Lu-PSMA-617 and pembrolizumab in treating persons with castration-resistant prostate cancer that has spread to other places in the body. 177Lu-PSMA-617 carries a radioactive component which attached to the prostate specific membrane antigen (PSMA) receptor found on tumor cells. Its radiation component destroys the tumor cell. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving 177Lu-PSMA-617 and pembrolizumab may work better at treating prostate cancer.
Primary Outcome
The Recommended Phase 2 Dosing Schedule (RP2DS) (Schedule 1: a single priming dose of 177Lu-PSMA-617 (7·4 giga-becquerel (GBq) \[200 millicurie (mCi)\] given 28 days before pembrolizumab; Schedule 2: a single priming dose of 177Lu-PSMA-617 given concomitant with pembrolizumab; or Schedule 3: a single priming dose of 177Lu-PSMA-617 given 21 days after the start of maintenance pembrolizumab (200 mg every 3 weeks)) will be determined from the safety data as classified by NCI Common Terminology Crit
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Lutetium Lu 177-PSMA-617
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2019-05-10 |
| Est. Completion | 2024-01-10 |
| Phase | Phase 1 |
What the finished NCT03805594 record still lists
NCT03805594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03805594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03805594 about?
NCT03805594 is a clinical study titled "177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer". This phase Ib trial studies the dose and schedule of 177Lu-PSMA-617 and pembrolizumab in treating persons with castration-resistant prostate cancer that has spread to other places in the body. 177Lu-PSMA-617 carries a radioactive component which attached to the prostate specific membrane antigen (PS...
What is the current status of trial NCT03805594?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2019-05-10. Estimated completion is 2024-01-10.
What interventions are being tested in trial NCT03805594?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Lutetium Lu 177-PSMA-617 (DRUG).
Who is sponsoring clinical trial NCT03805594?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03805594's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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