RecruitingPhase 2NCT06353906

Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer

A Phase 2 Clinical Study to Assess Efficacy of Induction Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer: PRIAM

Sponsor

The Netherlands Cancer Institute

Enrollment

27 participants

Start Date

Aug 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

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

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of chemotherapy drugs (carboplatin and paclitaxel) with an immunotherapy drug (pembrolizumab) for men with locally advanced penile cancer. The goal is to shrink the tumor enough before surgery to improve outcomes for this rare and difficult-to-treat cancer. **You may be eligible if...** - You are a man with a confirmed diagnosis of squamous cell carcinoma of the penis - Your cancer has spread to nearby lymph nodes or has limited spread to other sites that can be treated - You have not yet received treatment for this cancer - You are in good general health (ECOG score 0 or 1) - You agree to use contraception during and for at least 6 months after treatment **You may NOT be eligible if...** - You have uncontrolled serious medical conditions - You are unable to provide a tumor tissue sample - Your cancer has spread too widely to benefit from this approach Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCarboplatin/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)

DRUGPembrolizumab

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

PROCEDUREPartial 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

Locations(2)

UZ Leuven

Leuven, Belgium

NKI-AVL

Amsterdam, North Holland, Netherlands

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NCT06353906

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