DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma

NCT07110038 | Recruiting Phase 2

• 2 other identifiers: UKT-IKF-DEPECA-12025-521644-37-00
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 7

Brief Summary

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

Penile Squamous Cell Carcinoma (PSCC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) in 1st line as assessed by investigators, defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

  Up to 24 months.

Secondary Outcomes (7)

• Progression-free survival (PFS)

  Up to 5 years.

• Overall Survival (OS)

  Up to 5 years.

• Duration of Response (DoR)

  Up to 5 years.

• Disease Control Rate (DCR)

  Up to 27 months.

• Incidence and severity of (serious) adverse events

  Up to 27 months

Study Arms (1)

Combined therapy consisting of enfortumab vedotin and avelumab

EXPERIMENTAL

Drug: Avelumab; Drug: enfortumab vedotin

Interventions

Avelumab DRUG

Avelumab, 1,200 mg IV

Combined therapy consisting of enfortumab vedotin and avelumab

enfortumab vedotin DRUG

Enfortumab vedotin, 1.25 mg/kg IV

Combined therapy consisting of enfortumab vedotin and avelumab

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has ability to understand and the willingness to sign a written informed consent.
• Patient is ≥ 18 years of age at time of signing the written informed consent.
• Male patients with histologically confirmed diagnosis of penile squamous cell carcinoma.
• Stage 3 (cT3) disease with a single lymph node involved (N1).
• Stage 4 disease (cT4).
• Any T stage with either N2 (involvement of multiple or bilateral inguinal nodes) or N3 (fixed inguinal nodal mass or pelvic lymphadenopathy) disease. Patients without distant metastases are eligible if multidisciplinary team review concludes that they are unsuitable for curative surgery.
• Tumor material (archival or current) is available for local pathology testing (PD-L1, HPV).
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
• Measurable disease per RECIST 1.1 criteria.
• No prior systemic therapy for metastatic or locally advanced PeCa in the palliative setting. NOTE: (Neo)adjuvant systemic therapy (without IO) is allowed at least 6 months before study enrollment.
• Patients has adequate blood count, liver-enzymes, and renal function:
• ANC (Absolute neutrophil count) \> 1,500 cells/μL without the use of hematopoietic growth factors.
• Platelet count ≥ 100 x 109/L (\>100,000 per mm3).
• Hemoglobin ≥ 9 g/dL.
• Serum total bilirubin ≤ 1.5x institutional upper normal limit (ULN).

You may not qualify if:

• Previous systemic therapy for metastatic or locally advanced PeCa in the palliative setting.
• Previous treatment with investigational drugs or devices within 30 days prior to the first dose of trial treatment.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Active, known, or suspected autoimmune disease requiring systemic treatment within the past 2 years. Patients with controlled autoimmune d disease not requiring systemic immunosuppressive treatment including diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases are eligible.
• Has ongoing sensory or motor neuropathy Grade 2 or higher.
• Has a history of uncontrolled diabetes (HbA1c \> 8%).
• Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.
• Active infection requiring systemic therapy. The following exceptions apply:
• Patients with an HIV infection are eligible if they are on effective antiretroviral therapy with undetectable viral load within 6 months, provided there is no expected drug-drug interaction.
• Patients with evidence of chronic HBV infection are eligible if the HBV viral load is undetectable on suppressive therapy (if indicated), and if they have ALT, AST, and total bilirubin levels \< ULN, and provided there is no expected drug-drug interaction.
• Patients with a history of HCV infection are eligible if they have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load, and if they have ALT, AST, and total bilirubin levels \< ULN.
• History of other malignancies within the past 3 years, with the exception of adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin.
• Severe hepatic impairment (Child-Pugh Class C).
• Severe renal impairment or requirement for dialysis.
• History of keratitis and corneal ulceration in the last two years.

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead
• Merck KGaA, Darmstadt, Germany: collaborator
• Astellas Pharma GmbH: collaborator
• University Hospital Tübingen: collaborator

Study Sites (7)

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

RECRUITING

University Medical Center of Johannes Gutenberg-University

Mainz, Germany

RECRUITING

University Hospital Mannheim

Mannheim, Germany

RECRUITING

Technical University of Munich, University Hospital Munich

Munich, Germany

RECRUITING

Caritas St. Josef Medical Center

Regensburg, Germany

RECRUITING

Rostock University Medical Center

Rostock, Germany

RECRUITING

University Hospital Tübingen

Tübingen, Germany

RECRUITING

MeSH Terms

Interventions

avelumab; enfortumab vedotin

Study Officials

• Salah-Eddin Al-Batran, Prof. Dr.

  Frankfurter Institut für Klinische Krebsforschung IKF GmbH

  STUDY CHAIR

Central Study Contacts

Igor Tsaur, Prof. Dr.

CONTACT

+49 7071-29-86000; igor.tsaur@med.uni-tuebingen.de

Claudia Pauligk, Dr.

CONTACT

+49 69 5899 787 52; depeca-1@ikf-khnw.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: August 7, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: April 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7)