Actively Recruiting
A Phase 2 Clinical Study to Assess Efficacy of Induction Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer: PRIAM
Led by The Netherlands Cancer Institute · Updated on 2025-12-08
27
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of induction chemo-immunotherapy in adult men with locoregionally advanced squamous cell carcinoma of the penis that is suitable for surgical removal. This phase II trial includes patients with specific nodal involvement or lymph node recurrence, some with limited distant metastases that can be locally treated. The study aims to assess the pathological complete response after treatment and investigate correlations with tumor markers and quality of life. Participants will receive three 21-day cycles of chemotherapy with carboplatin and paclitaxel, combined with two doses of pembrolizumab during the first and third cycles. After completing induction therapy, a CT scan will evaluate response, followed by surgical removal of visible or suspected tumors within 3 to 9 weeks. Subsequently, patients enter an adjuvant phase with up to seven cycles of pembrolizumab every 6 weeks. Treatment monitoring includes physical exams, adverse event tracking, and blood tests before each cycle. Throughout the study, disease status will be monitored by CT scans at several intervals up to 24 months after surgery, followed by standard follow-up visits every 6 months. Quality of life will be assessed using questionnaires at multiple time points during the first two years. The primary outcome is the pathological complete response immediately after surgery, with secondary outcomes including treatment toxicity, progression-free and overall survival at two years, and correlations between clinical outcomes and tumor characteristics.
CONDITIONS
Brief Title
Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 years or older
- Histologically confirmed squamous cell carcinoma of the penis
- Disease stage cTxN2-3; or cTxN1 with central nodal necrosis, irregular nodal border, or node larger than 3 cm; or inguinal/pelvic lymph node recurrence potentially resectable
- Maximum of 2 distant metastases allowed if treatable by surgery or radiotherapy
- Provide archival or newly obtained tumor tissue biopsy, preferably formalin-fixed paraffin-embedded blocks
- Agreement to use contraception during treatment and for at least 180 days after last dose
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ function based on specified blood counts, liver enzymes, coagulation tests collected within 14 days prior to treatment start
You will not qualify if you...
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor agents
- Prior systemic anti-cancer therapy or investigational agents within 4 weeks before registration
- Radiotherapy within 4 weeks prior to study start or related corticosteroid-requiring toxicities
- Live vaccine within 30 days before first dose; killed vaccines allowed
- Immunodeficiency or recent systemic steroid or immunosuppressive therapy
- Additional progressing malignancy requiring treatment within past 3 years (with some exceptions)
- Active or treated central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years (except mild skin conditions)
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Concurrent active Hepatitis B or C infection without completed curative therapy
- Incomplete recovery from major surgery or ongoing surgical complications
- Major pelvic surgery within 4 weeks before enrollment or planned during study (except study-related surgery)
- Conditions or treatments interfering with study participation or outcomes
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Planning to father children during study and 120 days after last dose
- History of allogenic tissue or solid organ transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 9 weeks
Participants receive three 21-day cycles of induction chemotherapy with carboplatin and paclitaxel, combined with pembrolizumab on the first and third cycle.
3 treatment visits for chemotherapy and 2 pembrolizumab infusions
Duration - 1 day
Participants undergo surgical resection of all visible and/or suspected tumor tissue.
1 surgical procedure visit
Duration - Up to 42 weeks
Participants receive up to seven 6-week cycles of adjuvant pembrolizumab starting 3 to 9 weeks after surgery, with physical exams and blood tests at each cycle start.
7 infusion visits every 6 weeks with physical exams and blood tests
Duration - Up to 24 months post-surgery and ongoing every 6 months thereafter
Participants are monitored for disease status and quality of life with CT scans and questionnaires at scheduled intervals up to 24 months after surgery, followed by ongoing survival and treatment follow-up every 6 months.
CT scans and quality of life assessments at 3, 6, 9, 12, 18, and 24 months; then visits every 6 months
Trial Site Locations
Total: 2 locations
1
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
2
NKI-AVL
Amsterdam, North Holland, Netherlands, 1066CX
Actively Recruiting
Research Team
M
Michiel S. van der Heijden, PhD
J
Jan-Jaap J. Mellema, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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