Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer

Phase 2 Completed 37 enrolled Latin American Cooperative Oncology Group Merck Sharp & Dohme LLC · collab

NaSingle-groupOpen-labelTreatment

Summary

This is a phase II clinical trial evaluating activity, safety and patients reported outcomes of first-line pembrolizumab plus cisplatin (or carboplatin) plus 5-FU for patients with advanced penile squamous cell carcinoma. The primary endpoint is overall responsa rate according to RECIST v1.1 at week 24.

Timeline

Start: 2020-06-15
Primary completion: 2023-11-13
Completion: 2023-11-13

Publications

Cotait Maluf F, Trindade K, Preto D, de Almeida Luz M, Medeiros Milhomem Beato P, Assed Bastos D, Holanda Soares JP, Marcondes Lopes V, Werneck de Carvalho LE, Queiroz Borges Muniz D, Racy DJ, de Jesus RG, Rebelatto TF, Werutsky G, Halabi S, Sabino Marques Monteiro F, Poisl Fay A. Pembrolizumab Plus Platinum-Based Chemotherapy for Patients With Advanced Penile Cancer: The Nonrandomized HERCULES (LACOG 0218) Clinical Trial. JAMA Oncol. 2025 Nov 1;11(11):1314-1320. doi: 10.1001/jamaoncol.2025.3266.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pembrolizumab	Monoclonal antibody	200 mg	Intravenous
Background	Carboplatin	Small molecule	5 unknown	Intravenous
Background	Cisplatin	Other / unclassified	70 mg/m2	Intravenous
Background	fluorouracil	Small molecule	1000 mg/m2	Intravenous

Pembrolizumab Combined With Cisplatin-based Chemotherapy as First-line Systemic Therapy in Advanced Penile Cancer

Summary

Timeline

Publications

Drugs

Indications