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.
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).
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.
Single group
Avelumab
DrugAvelumab, 1,200 mg IV
enfortumab vedotin
DrugEnfortumab vedotin, 1.25 mg/kg IV
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.
Progression-free survival (PFS)
Progression-free survival (PFS), defined as the time from the start of treatment to the first documented disease progression acc. to RECIST 1.1 criteria or death from any cause, whichever occurs first.
Overall Survival (OS)
Time from the start of treatment to death from any cause.
Duration of Response (DoR)
Time from the first documented response (CR or PR) to disease progression or death from any cause (whichever occurs first).
Disease Control Rate (DCR)
Disease Control Rate (DCR), defined as the proportion of patients achieving CR, PR, or stable disease (SD) according to RECIST 1.1 criteria.
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Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Lead sponsor
Merck KGaA, Darmstadt, Germany
Collaborator
Astellas Pharma GmbH
Collaborator
University Hospital Tuebingen
Collaborator
