MedTrace Logo

Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer

NCT06353906 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-12-08

No results posted yet for this study

Summary

This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis

Conditions

  • Urologic Neoplasms
  • Urogenital Neoplasms
  • Male Urogenital Diseases
  • Penile Cancer
  • Penile Squamous Cell Carcinoma
  • Locally 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

Sponsors & Collaborators

Principal Investigators

  • Michiel S. van der Heijden, PhD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2026-10-14
Completion
2028-01-14

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06353906 on ClinicalTrials.gov