NCT06353906

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is a phase II study in which fifty adult patients with cTxN1-3 locoregionally advanced squamous cell penile cancer (LRAPC), suitable for resection will be included. Patients with recurrence in lymph nodes are suitable for inclusion if they have not received prior systemic treatment. Patients with cN1 are only included in case of central nodal necrosis and/or an irregular nodal border, or node \>3cm on CT. A maximum of 2 supraregional or distant metastases is allowed if local treatment (i.e. irradiation or resection) is feasible. Patients will be treated with three 21-day cycles of induction chemotherapy, carboplatin AUC5 (max 750 mg) and paclitaxel 175 mg/m2, with additional fixed-dose 400mg pembrolizumab on the first and third cycle. Response to induction therapy will be evaluated by CT scan, ca. 2 weeks after the last cycle. Subsequent consolidative treatment will consist of surgical resection of all visible and/or suspected disease. In 3-9 weeks after surgery, patients will enter the adjuvant phase, consisting of 7 cycles of pembrolizumab 400 mg every 6 weeks. Focused physical examination, registration of adverse-events and monitoring of, amongst others, TSH, FT4, liver enzymes via blood tests, is performed at the start of every cycle. End of treatment visit will be set 30 days after receiving the last cycle of pembrolizumab. Disease status will be monitored by CT-scan at 3, 6, 9, 12, 18 and 24 months from resection, after which imaging will follow standard follow-up protocols. QoL will be assessed at 3,6,12, 18 and 24 months using using the EORTC QLQ-C30 questionnaire. Following 24 months after resection subsequent follow-up visits for survival and anti-cancer therapy will be planned every 6 months, until death, withdrawal of consent or the end of the study, whichever occurs first. The primary endpoint is efficacy, defined as pathological complete response (pCR). Secondary endpoints are grade 3-4 toxicity (by CTCAE 5.0), PFS and OS at 2 years after surgery, correlation of clinical endpoints (pCR, PFS, OS) with high-risk HPV (hrHPV) and PD-L1 immunohistochemistry, and quality of life.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-13
• Primary completion: 2026-10-14
• Completion: 2028-01-14
• First posted: 2024-04-09
• Last updated: 2025-12-08

Locations

2 sites across 2 countries: Belgium, Netherlands