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New treatment option for Penile Squamous Cell Carcinoma (PSCC)
Official title DEPECA-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
What this study is testing
What is Avelumab?
Avelumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for penile squamous cell carcinoma (pscc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join 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.
- Patients must be considered non-eligible for curative surgical management. Eligibility for trial inclusion should be based on the presence of either...
- Stage 3 (cT3) disease with a single lymph node involved (N1).
You likely can't join 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...
- Has ongoing sensory or motor neuropathy Grade 2 or higher.
- Has a history of uncontrolled diabetes (HbA1c \> 8%).
See the full eligibility criteria
Who can 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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)...
- 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...
- Patient participated in another treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Dresden, Germany
- Düsseldorf, Germany
- Mainz, Germany
- Mannheim, Germany
- Munich, Germany
- Regensburg, Germany
- Rostock, Germany
- Tübingen, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dresden, Germany; Düsseldorf, Germany; Mainz, Germany; Mannheim, Germany; Munich, Germany; Regensburg, Germany and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.