drugset / Trial / NCT06388369
Neoadjuvant Lu-PSMA Radioligand Therapy and Ipilimumab in Men With Very High-risk Prostate Cancer
Phase 1/2
Terminated
1 enrolled
University Hospital, Essen
Advanced Accelerator Applications · collabBristol-Myers Squibb · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
A randomized, open-label Phase I/II study of neoadjuvant treatment with \[177Lu\]Lu-PSMA-617 radioligandtherapy (LuPSMA) with or without Ipilimumab in participants with very high-risk prostate cancer who are candidates for Radical Prostatectomy.
Timeline
- Start
- 2025-08-25
- Primary completion
- 2026-03-09
- Completion
- 2026-03-09
Outcome
Outcome not reported
Stopped (Enrollment): “The clinical trial has been terminated due to the revocation of funding. Although one subject was enrolled, the participant withdrew prior to receiving any treatment. No trial-related procedures generating evaluable clinical data were performed.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | — |
| Subject | [177Lu]Lu-PSMA-617 | Other / unclassified | 3.7 mbq | — |
| Subject | [177Lu]Lu-PSMA-617 | Other / unclassified | 7.4 mbq | — |