OncoMatch/Clinical Trials/NCT05766371
Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer
Is NCT05766371 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and 177Lu-PSMA-617 for castrate resistant prostate cancer.
Treatment: Pembrolizumab · 177Lu-PSMA-617 — This is a single-center, open-label, study of Prostate-Specific Membrane Antigen (PSMA)-targeted radionuclide therapy with 177Lu-PSMA-617 in combination with pembrolizumab in participants with metastatic castrate-resistant prostate cancer (mCRPC) who have previously progressed on at least one prior androgen pathway inhibitor (e.g., abiraterone, enzalutamide, apalutamide).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Radioligand therapy
Cancer type
Prostate Cancer
Biomarker criteria
Required: FOLH1 psma pet avid lesion (uptake above background liver)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: second generation androgen signaling inhibitor (abiraterone, apalutamide, darolutamide, enzalutamide)
Prior progression on at least one second generation androgen signaling inhibitor including abiraterone, apalutamide, darolutamide, and/or enzalutamide.
Cannot have received: PSMA-directed treatment
Receipt of prior PSMA-directed treatment (e.g., radiotherapy, immunotherapy, or antibody-drug conjugate).
Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-Programmed cell death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), OX 40, CD137).
Cannot have received: taxane
Exception: ≤ 2 lines allowed
Receipt of > 2 lines of prior taxane-based chemotherapy.
Lab requirements
Blood counts
absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL; hemoglobin > 9.0 g/dL
Kidney function
creatinine ≤ 1.5 x ULN OR creatinine clearance/GFR ≥ 50 mL/min/1.73 m^2
Liver function
total bilirubin ≤ 1.5 x ULN (direct bilirubin ≤ ULN if Gilbert's disease); AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases); ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases)
Demonstrates adequate organ function as defined below: Adequate bone marrow function: absolute neutrophil count ≥1,500/mcL; platelets ≥100,000/mcL; hemoglobin > 9.0 g/dL. Adequate hepatic function: total bilirubin ≤ 1.5 x ULN (direct bilirubin ≤ ULN if Gilbert's disease); AST/SGOT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases); ALT/SGPT ≤ 2.5 x ULN (≤ 5 x ULN with liver metastases). Adequate renal function: creatinine ≤ 1.5 x ULN OR creatinine clearance/GFR ≥ 50 mL/min/1.73 m^2.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, San Francisco · San Francisco, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05766371 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PSMA-directed treatment, anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy, taxane disqualifies patients from enrollment.
Does this trial require FOLH1?
Yes, FOLH1 psma pet avid lesion is a required biomarker for enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages