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

Sponsor
Bristol-Myers Squibb
Study ID
NCT05496192
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
May 31, 2023
Status verified
Apr 2023
Primary completion
Jun 24, 2024
Completion
Jun 24, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab IV followed by Nivolumab SC

Primary Outcome Measure

Proportion of Participants That Prefer Nivolumab SC at the First Assessment of Patient Preference Using Patient Experience and Preference Questionnaire (PEPQ) (Question 1) [ Time Frame: Up to 24 hours after first full dose at Cycle 4, Day 1 (98 Days) ]

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