Actively Recruiting
DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
Led by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Updated on 2026-04-16
25
Participants Needed
7
Research Sites
254 weeks
Total Duration
On this page
Sponsors
I
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
The DEPECA-1 trial is the first systematic Phase II trial to evaluate response and survival to a combination of antibody-drug conjugate enfortumab vedotin plus the PD-L1 inhibitor avelumab in patients with locally advanced and metastatic penile squamous cell carcinoma (PeCa) in the 1st line setting.
CONDITIONS
Official Title
DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willing to sign informed consent.
- Male patients aged 18 years or older.
- Histologically confirmed penile squamous cell carcinoma.
- Not eligible for curative surgery due to distant metastases or advanced local disease (Stage 3 or 4, or N2/N3 nodal involvement).
- Available tumor material for pathology testing (PD-L1, HPV).
- ECOG performance status 0 to 2.
- Measurable disease by RECIST 1.1 criteria.
- No prior systemic therapy for metastatic or locally advanced penile cancer in palliative setting; (neo)adjuvant therapy without immunotherapy allowed if completed at least 6 months prior.
- Adequate blood counts, liver enzymes, and renal function.
- No other active malignancy within past 3 years except treated basal or squamous cell carcinoma of the skin.
- No significant cardiovascular disease in past 6 months.
- Life expectancy of at least 3 months.
- Willingness to comply with study procedures and follow-up.
- Use of effective contraception if having female partners of childbearing potential during study and specified times after treatment.
You will not qualify if you...
- Previous systemic therapy for metastatic or locally advanced penile cancer in palliative setting.
- Treatment with investigational drugs or devices within 30 days before study treatment.
- Active central nervous system metastases or carcinomatous meningitis.
- Active autoimmune disease needing systemic treatment within past 2 years (controlled autoimmune diseases allowed).
- Ongoing sensory or motor neuropathy Grade 2 or higher.
- Uncontrolled diabetes (HbA1c > 8%).
- Active significant cardiovascular disease within 6 months prior.
- Active infection requiring systemic therapy, with exceptions for controlled HIV, HBV, or cured/controlled HCV.
- Other malignancies within past 3 years except treated basal or squamous cell skin cancer.
- Severe liver or kidney impairment.
- History of keratitis or corneal ulcers in last 2 years.
- Active pneumonia, pneumonitis, pulmonary fibrosis, or tuberculosis.
- Severe hypersensitivity to study drugs or monoclonal antibodies.
- Inability or unwillingness to comply with study requirements or provide informed consent.
- Use of immunosuppressive medication within 14 days prior, with some steroid exceptions.
- Prior organ transplantation.
- Vaccination within 4 weeks before first dose except inactivated vaccines.
- Persisting toxicity from prior therapy worse than Grade 1 except alopecia or judged safe.
- Other severe acute or chronic medical or psychiatric conditions increasing risk or interfering with study participation.
- Participation in another interventional clinical study within 28 days prior or concurrent with this study except observational or during follow-up period.
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Universitätsklinikum Carl Gustav Carus
Dresden, Germany
Actively Recruiting
2
University Medical Center of Johannes Gutenberg-University
Mainz, Germany
Actively Recruiting
3
University Hospital Mannheim
Mannheim, Germany
Actively Recruiting
4
Technical University of Munich, University Hospital Munich
Munich, Germany
Actively Recruiting
5
Caritas St. Josef Medical Center
Regensburg, Germany
Actively Recruiting
6
Rostock University Medical Center
Rostock, Germany
Actively Recruiting
7
University Hospital Tübingen
Tübingen, Germany
Actively Recruiting
Research Team
I
Igor Tsaur, Prof. Dr.
CONTACT
C
Claudia Pauligk, Dr.
CONTACT
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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