OncoMatch/Clinical Trials/NCT05766371
Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer
Is NCT05766371 recruiting? Yes, currently enrolling (May 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
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)
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 →
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 qualify