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Szukaj Study Connect
  • NCT05496192

Not Yet Recruiting

A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer - CA209-6L6

Zaktualizowano: 22 marzec, 2023   |   ClinicalTrials.gov

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Szczegóły badania

  • Phase 2

    Etap

  • Płeć

  • 18+

    Zakres wieku

  • 3

    Lokalizacje

  • Not Yet Recruiting

Opcje leczenia

Grupy badania
PRZYPISANA INTERWENCJA
Experimental: Nivolumab IV followed by Nivolumab SC
Drug: Nivolumab/rHuPH20 Drug: Nivolumab

Kluczowe kryteria kwalifikacyjne

Inclusion Criteria: - Participant must have Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. - Participants must be eligible for adjuvant therapy for melanoma or muscle-invasive Urothelial Carcinoma (UC) originating from the bladder. - All participants must have disease-free status (DFS) documented by a complete physical examination and imaging studies within 4 weeks prior to treatment assignment. Exclusion Criteria: - History of ocular or uveal or mucosal melanoma. - Upper tract UC (ureter, renal pelvis), non-muscle-invasive UC. - Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment. - Untreated/unresected Central Nervous System (CNS) or leptomeningeal metastases. Other protocol-defined inclusion/exclusion criteria apply