University Hospital Tübingen Launches DEPECA-1 Trial Testing Enfortumab Vedotin-Avelumab Combination for Advanced Penile Cancer
Key Insights
University Hospital Tübingen has initiated the first study site for the DEPECA-1 phase-2 trial, marking a significant milestone for advanced penile cancer (search) treatment research.
The investigator-initiated trial will evaluate the combination of enfortumab vedotin and avelumab as first-line therapy for male patients with surgically incurable locally advanced or metastatic penile cancer (search).
Patient recruitment is expected to begin in December 2025, with the study sponsored by IKF (search) and funded by Merck Group (search) and Astellas Pharma.
University Hospital Tübingen has become the first study site to launch the DEPECA-1 trial, a phase-2 investigator-initiated study testing a novel drug combination for patients with advanced penile cancer (search). The trial will evaluate enfortumab vedotin combined with avelumab as first-line treatment for male patients with surgically incurable locally advanced and/or metastatic penile cancer.
Trial Design and Patient Population
The DEPECA-1 trial is a national multicenter study led by the Department of Urology at Eberhard-Karls-University of Tübingen. The phase-2 trial specifically targets male patients with surgically incurable locally advanced or metastatic penile cancer (search), a patient population with significant unmet medical needs and limited therapeutic options.
According to Igor Tsaur, Director and Chairman of the Department of Urology at University Hospital Tübingen, patient inclusion is anticipated to begin in December 2025. The study represents the first investigation of this drug combination in the first-line setting for advanced penile cancer (search).
Therapeutic Approach
The trial will test the combination of enfortumab vedotin, an antibody-drug conjugate, with avelumab, an anti-PD-L1 (search) monoclonal antibody. This combination therapy approach aims to leverage both targeted drug delivery and immune checkpoint inhibition mechanisms to improve treatment outcomes for patients with advanced penile cancer (search).
The selection of this drug combination reflects the growing trend toward combination immunotherapy approaches in oncology, particularly for cancers with poor prognoses and limited treatment options.
Study Sponsorship and Funding
The DEPECA-1 trial is sponsored by IKF (search) – The Frankfurt Institute of Clinical Cancer Research and receives funding from Merck Group (search) and Astellas Pharma. This collaborative funding structure demonstrates industry commitment to advancing research in rare urological malignancies.
Clinical Significance
Tsaur emphasized the potential impact of the trial, stating his hope to "finally improve life expectancy in this disease." This statement underscores the urgent need for effective treatments in advanced penile cancer (search), where current therapeutic options remain limited and prognosis is generally poor.
The initiation of the first study site represents a significant milestone in penile cancer (search) research, as investigator-initiated trials in this rare malignancy are uncommon. The multicenter design of the study is expected to facilitate patient recruitment across multiple institutions, potentially accelerating enrollment and results generation.
Patient Recruitment Strategy
The research team is actively encouraging referrals from healthcare providers, with Tsaur noting the importance of utilizing "this unique opportunity" and referring patients to the nearest study site. This approach reflects the challenges of conducting clinical trials in rare cancers, where patient identification and recruitment can be particularly difficult.