drugset / Trial / NCT07110038
DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
Phase 2
Recruiting
25 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Astellas Pharma Inc · collabMerck KGaA, Darmstadt, Germany · collabUniversity Hospital Tübingen · collab
NaSingle-groupOpen-labelTreatment
Summary
The DEPECA-1 trial is the first systematic Phase II trial to evaluate response and survival to a combination of antibody-drug conjugate enfortumab vedotin plus the PD-L1 inhibitor avelumab in patients with locally advanced and metastatic penile squamous cell carcinoma (PeCa) in the 1st line setting.
Timeline
- Start
- 2025-12-16
- Primary completion
- 2029-05
- Completion
- 2030-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avelumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Enfortumab Vedotin | Other / unclassified | 1.25 mg/kg | Intravenous |