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New treatment option for Metastatic Penile Squamous Cell Carcinoma
Official title Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis
ClinicalTrials.gov ID: NCT06104618
What this study is testing
What is Enfortumab Vedotin?
Enfortumab Vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic penile squamous cell carcinoma.
Also referred to as AGS 22ME, AGS-22M6E.
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
- This phase II trial tests how well enfortumab vedotin works for treating patients with squamous cell carcinoma of the penis that has spread to other places in the body (metastatic) or cannot be removed by surgery (unresectable). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
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. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 years
- Histological confirmation of squamous cell carcinoma of the penis (PSCC): NOTE: Biopsy confirmation of at least one site of metastasis is encouraged...
- At least one site of metastatic or unresectable PSCC. NOTE: Prior therapy is not required for patients whose treatment is considered palliative (for...
- Any T, N1 (i.e., a palpable mobile unilateral inguinal lymph node), M0 OR
- Any T, N2 (i.e., palpable mobile multiple or bilateral inguinal lymph nodes), M0 OR
You likely can't join if
- Pure verrucous carcinoma of the penis
- Non-squamous malignancy of the penis
- Squamous carcinoma of the urethra
- Preexisting sensory or motor neuropathy ≥ grade 2
- Active central nervous system (CNS) metastases. Exception: Treated CNS metastases are allowed if all of the following are true:
- CNS metastases are clinically stable for ≥ 6 weeks prior to registration
See the full eligibility criteria
Who can join
- Age ≥ 18 years
- Histological confirmation of squamous cell carcinoma of the penis (PSCC): NOTE: Biopsy confirmation of at least one site of metastasis is encouraged but not required.
- At least one site of metastatic or unresectable PSCC. NOTE: Prior therapy is not required for patients whose treatment is considered palliative (for example, presence of distant metastasis). NOTE: Patients who are...
- Any T, N1 (i.e., a palpable mobile unilateral inguinal lymph node), M0 OR
- Any T, N2 (i.e., palpable mobile multiple or bilateral inguinal lymph nodes), M0 OR
- Any T, N3 (i.e., fixed inguinal nodal mass or any pelvic lymphadenopathy), M0 OR
- Any T, any N, M1
- Patients with clinical N1, M0 mPSCC at protocol entry must be ineligible for surgery because of comorbidities or clinical T4 disease, or have refused surgery
- Patients with clinical N1 - N3, M0, and no prior systemic therapy must be:
- Unable to receive neoadjuvant (paclitaxel + ifosfamide + cisplatin) TIP because of comorbidities or refused TIP; AND
- Unable to receive radiotherapy with curative intent, or refused radiotherapy
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
- Prior therapy is allowed. Patients may be treatment-naïve or have had any number of prior anti-cancer treatments
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- Hemoglobin ≥ 9.0 g/dL obtained ≤15 days prior to registration
- Absolute neutrophil count (ANC) ≥ 1000/mm\^3 obtained ≤ 15 days prior to registration
- Platelet count ≥ 100,000/mm\^3 obtained ≤ 15 days prior to registration
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN for patients with Gilbert's disease obtained ≤ 15 days prior to registration
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN obtained ≤ 15 days prior to registration
- Glomerular filtration rate (GFR) or calculated creatinine clearance ≥ 30 ml/min as estimated using the Cockcroft-Gault formula or as measured by 24-hour urine collection obtained ≤ 15 days prior to registration
- Provide written informed consent
- Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
What rules you out
- Pure verrucous carcinoma of the penis
- Non-squamous malignancy of the penis
- Squamous carcinoma of the urethra
- Preexisting sensory or motor neuropathy ≥ grade 2
- Active central nervous system (CNS) metastases. Exception: Treated CNS metastases are allowed if all of the following are true:
- CNS metastases are clinically stable for ≥ 6 weeks prior to registration
- If needed, steroid dose is stable and ≤ 20 mg/day of prednisone or equivalent for ≥ 2 weeks prior to registration
- Baseline imaging shows no evidence of new or enlarged brain metastasis
- No leptomeningeal disease
- History of uncontrolled diabetes mellitus ≤ 3 months prior to registration NOTE: Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥ 8.0% or HbA1c 7.0-7.9% with associated diabetes symptoms (polyuria or...
- Failure to recover from any of the following therapies prior to registration:
- Major surgery
- Radiotherapy, chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy
- Immunocompromised patients and patients known to be human immunodeficiency virus (HIV) positive
- Uncontrolled intercurrent illness including, but not limited to:
- Ongoing or active infection requiring systemic treatment
- History of cerebral vascular event (stroke or transient ischemic attack)
- Myocardial infarction or symptomatic congestive heart failure (New York Heart Association [NYHA] Class III-IV) ≤ 6 months prior to registration
- Unstable angina pectoris
- Cardiac arrhythmia
- Or psychiatric illness/social situations that would limit compliance with study requirements (e.g., history of substance abuse)
- Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
- Currently receiving systemic antimicrobial treatment for viral, bacterial or fungal infection. NOTE: Routine antimicrobial prophylaxis is allowed
- Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or active hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid (RNA) [qualitative] is detected)
- Known active keratitis or corneal ulcerations. NOTE: Superficial punctate keratitis is allowed if the disorder is being adequately treated
- Known hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate and polysorbate 20) OR subject has known...
- Other active malignancy ≤ 2 years prior to registration. EXCEPTIONS: Locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, or carcinoma...
- History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
- Patients who are sexually active and unwilling to use effective contraception (if they are not already surgically sterile)
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper...
- Chemotherapy-naïve patients who are potentially curable (any T, N1 - N3, M0) in the absence of any condition that precludes cisplatin-based chemotherapy, such as low GFR, peripheral neuropathy, hearing impairment, or...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States. 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.