OncoMatch/Clinical Trials/NCT06104618
Enfortumab Vedotin for the Treatment of Patients With Metastatic or Unresectable Squamous Cell Carcinoma of the Penis
Is NCT06104618 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Enfortumab Vedotin for metastatic penile squamous cell carcinoma.
Treatment: Enfortumab Vedotin — 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. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them.
Check if I qualifyExtracted eligibility criteria
Cancer type
Penile Carcinoma
Disease stage
Required: Stage ANY T, N1, M0, ANY T, N2, M0, ANY T, N3, M0, ANY T, ANY N, M1 (AJCC v8)
Eligible stages include: 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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1000/mm^3; Platelet count ≥ 100,000/mm^3
Kidney function
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
Liver function
Total bilirubin ≤ 1.5 x ULN or ≤ 3 x ULN for patients with Gilbert's disease; ALT and AST ≤ 2.5 x ULN
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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic Hospital in Arizona · Phoenix, Arizona
- Mayo Clinic in Florida · Jacksonville, Florida
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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