Actively Recruiting
Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer
Led by The Netherlands Cancer Institute · Updated on 2025-12-08
27
Participants Needed
2
Research Sites
178 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
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
Official Title
Carboplatin/Paclitaxel + Pembrolizumab for Locoregionally Advanced Penile Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients with 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
- Inguinal or pelvic lymph node recurrence that can be surgically removed
- Maximum of 2 distant metastases if treatable by surgery or radiotherapy
- Archival or newly obtained tumor biopsy tissue available
- Agree to use contraception during treatment and for at least 180 days after last dose
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate organ function as defined by specified blood counts and liver/kidney function tests within 14 days before treatment
You will not qualify if you...
- Prior treatment with anti-PD-1, anti-PD-L1, or similar immunotherapy agents
- Prior systemic anti-cancer therapy or investigational device within 4 weeks before registration
- Radiotherapy within 4 weeks before treatment or radiation-related toxicities needing corticosteroids
- Live or live-attenuated vaccine within 30 days before treatment
- Immunodeficiency or recent use of high-dose systemic steroids or immunosuppressants
- Active or recent other malignancies requiring treatment within 3 years (with exceptions)
- Known active or treated brain metastases or carcinomatous meningitis
- Severe allergy to pembrolizumab or its components
- Active autoimmune disease needing systemic treatment in last 2 years (except certain mild conditions)
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic therapy
- Known HIV infection
- Active Hepatitis B or C infection unless cured at least 6 months prior
- 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 safety
- Psychiatric or substance abuse disorders affecting study compliance
- Expecting 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
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
CONTACT
J
Jan-Jaap J. Mellema, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here