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

Last updated: April 12, 2023
Sponsor: Bristol-Myers Squibb
Overall Status: Trial Not Available

Phase

2

Condition

Melanoma

Carcinoma

Urothelial Carcinoma

Treatment

N/A

Clinical Study ID

NCT05496192
CA209-6L6
U1111-1273-4725
2022-000294-67
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance statusscore of 0 or 1.
  • Participants must be eligible for adjuvant therapy for melanoma or muscle-invasiveUrothelial Carcinoma (UC) originating from the bladder.
  • All participants must have disease-free status (DFS) documented by a complete physicalexamination and imaging studies within 4 weeks prior to treatment assignment.

Exclusion

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 ofprior 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

Study Design

Study Start date:
May 31, 2023
Estimated Completion Date:
June 24, 2026

Connect with a study center

  • Local Institution - 0020

    Essen, North Rhine-Westphalia 45136
    Germany

    Site Not Available

  • Local Institution - 0001

    Berlin, 10117
    Germany

    Site Not Available

  • Local Institution - 0002

    Sevilla, 41013
    Spain

    Site Not Available

  • Tennessee Oncology PLLC

    Nashville, Tennessee 37203-1624
    United States

    Site Not Available

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