DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plu… (NCT07110038) | Clinical Trial Compass
RecruitingPhase 2
DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
Germany25 participantsStarted 2025-12-16
Plain-language 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.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. 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.
✓. Patients must be considered non-eligible for curative surgical management. Eligibility for trial inclusion should be based on the presence of either distant metastatic disease (M1) or at least one of the following scenarios based on the UICC/AJCC 8th edition TNM clinical and pathological classification of penile cancer:
✓. 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).
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Up to 24 months.
Trial details
NCT IDNCT07110038
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
. 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: