Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

August 13, 2024

Primary Completion Date

October 14, 2026

Study Completion Date

January 14, 2028

Conditions
Urologic NeoplasmsUrogenital NeoplasmsMale Urogenital DiseasesPenile CancerPenile Squamous Cell CarcinomaLocally Advanced Penile Carcinoma
Interventions
DRUG

Carboplatin/Paclitaxel

Induction: three cycles of intravenous carboplatin AUC5 (max 750 mg) and paclitaxel 175 mg/m2, during cycle 1, 2 and 3 (day 1, 22, 43)

DRUG

Pembrolizumab

"Induction: two cycles of intravenous pembrolizumab 400 mg during cycle 1 and 3 (day 1 and 43)~Adjuvant: up to seven cycles of fixed-dose intravenous pembrolizumab 400 mg, on day 1 every 6 weeks within 3-9 weeks after surgery"

PROCEDURE

Partial or total penectomy with inguinal and/or pelvic lymph node dissection

Resection of part or all of the penis with complete removal of suspect lymphnodes in the inguinal and/or pelvic area

Trial Locations (2)

3000

NOT_YET_RECRUITING

UZ Leuven, Leuven

1066CX

RECRUITING

NKI-AVL, Amsterdam

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

The Netherlands Cancer Institute

OTHER