Penile Squamous Cell Carcinoma (PSCC)Phase 2NCT07110038
DEPECA-1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
A Phase 2 study testing Avelumab and enfortumab vedotin in people with Penile Squamous Cell Carcinoma (PSCC), run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 9 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Penile Squamous Cell Carcinoma (PSCC)
- What is being tested?
- Avelumab and enfortumab vedotin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 9 sitesGermany
- Study dates
- 16 Dec 2025to Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional ULN (or ≤ 5 x ULN if liver metastases are present).
- Creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft- Gault equation (or local institutional standard method).
- No other active malignancy within the past 3 years, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin.
- No history of significant cardiovascular disease (e.g., myocardial infarction, unstable angina) within the last 6 months.
- Life expectancy of at least 3 months.
- Willingness to comply with study requirements, including follow-up visits and procedures.
- Patients with female partners of childbearing potential must agree to use an effective method of contraception during the study and for 4 months after the last dose of enfortumab vedotin or for at least 30 days after last avelumab treatment administration, whichever occurs last.
Who cannot join
- 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%).
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- 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.
- Active pneumonia, pneumonitis or pulmonary fibrosis.
- Active tuberculosis.
- Known prior severe hypersensitivity to the study drugs or any component of their formulations, known severe hypersensitivity reactions to monoclonal antibodies (NCT CTCAE Grade ≥ 3).
- Inability or unwillingness to comply with study requirements, including follow-up visits and procedures.
- Inability to provide informed consent.
- Use of immunosuppressive medication within 14 days prior to the first dose of study treatment, with the exception of intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra-articular injection), systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent, or steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication).
- Prior organ transplantation including allogenic stem-cell transplantation.
- Vaccination within 4 weeks of the first dose of avelumab and while on trials is prohibited except for administration of inactivated vaccines.
- Persisting toxicity related to prior therapy (NCI CTCAE Grade > 1); however, alopecia or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.
- Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Patient participated in another interventional clinical study according to Medicines Act within 28 days prior to study enrollment or participation in a clinical study according to Medicines Act at the same time as this study unless it is an observational / non-interventional study or during the follow- up period of an interventional study.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Germany9 sites, 9 recruiting
- Recruiting
Universitätsklinikum Carl Gustav Carus
Dresden
Christian Thomas, Prof. Dr.
- Recruiting
University Hospital and Medical Faculty, Heinrich-Heine-University, Düsseldorf
Düsseldorf
Günter Niegisch, Prof. Dr.
- Recruiting
University Medical Center of Johannes Gutenberg-University
Mainz
Anita Thomas, PD Dr.
- Recruiting
University Hospital Mannheim
Mannheim
Benjamin Meister, Dr.
- Recruiting
University Hospital Munich
München
Nikolaos Pyrgidis, PD Dr.
- Recruiting
Technical University of Munich, University Hospital Munich
Munich
Margitta Retz, Prof. Dr.
- Recruiting
Caritas St. Josef Medical Center
Regensburg
Marco Schnabel, PD Dr.
- Recruiting
Rostock University Medical Center
Rostock
Angelika Borkowetz, Prof. Dr.
- Recruiting
University Hospital Tübingen
Tübingen
Igor Tsaur, Prof. Dr.
Igor Tsaur, Prof. Dr.
About this study
Official title: DEPECA-1 - DEfeating PEnile Cancer 1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
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)
- Being tested
- Avelumab, enfortumab vedotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Avelumab, 1,200 mg IV
enfortumab vedotinDrug
Enfortumab vedotin, 1.25 mg/kg IV
| Study group | Role | What they receive |
|---|---|---|
| Combined therapy consisting of enfortumab vedotin and avelumab | Experimental | Not described Receives: Drug: Avelumab; Drug: enfortumab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 months.
Secondary outcomes (7)
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.
Measured: Up to 5 years.
Overall Survival (OS)
Time from the start of treatment to death from any cause.
Measured: Up to 5 years.
Duration of Response (DoR)
Time from the first documented response (CR or PR) to disease progression or death from any cause (whichever occurs first).
Measured: Up to 5 years.
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.
Measured: Up to 27 months.
Incidence and severity of (serious) adverse events
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Up to 27 months
Quality of life (QoL) using EQ-5D-5L questionnaire
Changes in patient-reported quality of life, using EQ-5D-5L questionnaire and a set of bolt-on questions will be collected.
Measured: Up to 24 months.
Quality of life (QoL) using EQ-HWB-S questionnaire
Changes in patient-reported quality of life, using EQ-HWB-S questionnaire and a set of bolt-on questions will be collected.
Measured: Up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start16 Dec 2025
- Primary completionMay 2029 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile Squamous Cell Carcinoma (PSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany, Astellas Pharma GmbH, University Hospital Tuebingen
- Responsible party
- Sponsor
- Investigators
- Salah-Eddin Al-Batran, Prof. Dr., Study chair, Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110038
- Sponsor's protocol ID
- UKT-IKF-DEPECA-1
- Other IDs
- 2025-521644-37-00, 2025
- Status last verified
- Jan 2026
- First submitted
- 18 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEPECA-1 - DEfeating PEnile Cancer 1 - A Phase II Study to Evaluate a First-line Systemic Therapy With Enfortumab Vedotin Plus Avelumab for Advanced and Metastatic Penile Carcinoma
- ClinicalTrials.gov ID
- NCT07110038
- Acronym / sponsor ID
- UKT-IKF-DEPECA-1
- Conditions
- Penile Squamous Cell Carcinoma (PSCC)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus NordwestUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany, Astellas Pharma GmbH, University Hospital Tuebingen
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combined therapy consisting of enfortumab vedotin and avelumab | Experimental | Drug: Avelumab, Drug: enfortumab vedotin |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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:
- Tumor material (archival or current) is available for local pathology testing (PD-L1, HPV).
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAvelumab, 1,200 mg IV | Drug | Combined therapy consisting of enfortumab vedotin and avelumab |
| enfortumab vedotinEnfortumab vedotin, 1.25 mg/kg IV | Drug | Combined therapy consisting of enfortumab vedotin and avelumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 24 months.
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.
7 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 5 years.
Overall Survival (OS)
Time frame: Up to 5 years.
Duration of Response (DoR)
Time frame: Up to 5 years.
Disease Control Rate (DCR)
Time frame: Up to 27 months.
Incidence and severity of (serious) adverse events
Time frame: Up to 27 months
Quality of life (QoL) using EQ-5D-5L questionnaire
Time frame: Up to 24 months.
Quality of life (QoL) using EQ-HWB-S questionnaire
Time frame: Up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Penile Squamous Cell Carcinoma (PSCC)
Not yet recruitingPhase 2
Neoadjuvant Pucotenlimab and Becotatug Vedotin for Locally Advanced Penile Cancer
Penile Cancer, Penile Squamous Cell Carcinoma (PSCC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salah-Eddin Al-Batran, Prof. Dr. study chair
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avelumab and enfortumab vedotin in people with Penile Squamous Cell Carcinoma (PSCC), run by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest at 9 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Igor Tsaur, Prof. Dr. (+49 7071-29-86000, igor.tsaur@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.