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BMS Not Yet Recruiting Study icon

Not Yet Recruiting

Trial ID CA209-6L6  |   NCT05496192

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

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Sorry, this study is not yet accepting participants.
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Summary

  • Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • 3
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

The purpose of this study is to evaluate the switch from Nivolumab Intravenous (IV) infusions to Nivolumab Subcutaneous (SC) administration in participants with resected Stage IIIA/B/C/D or Stage IV melanoma or resected invasive Urothelial Carcinoma (UC) originating in the bladder who have high risk of recurrence.

Key Eligibility Criteria

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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Nivolumab IV followed by Nivolumab SC

ASSIGNED INTERVENTION
  • Drug: Nivolumab Drug: Nivolumab/rHuPH20
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