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

Phase 2

Withdrawn

• Conditions: Melanoma; Urothelial Carcinoma
• Interventions: Drug: Nivolumab/rHuPH20; Drug: Nivolumab

• Registration Number: NCT05496192
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-12
• Last Update Posted: 2023-04-14
• Study Start: 2023-05-31
• Primary Completion: 2024-06-24
• Study Completion: 2026-06-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nivolumab IV followed by Nivolumab SC	Nivolumab/rHuPH20	-
Nivolumab IV followed by Nivolumab SC	Nivolumab	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Proportion of Participants That Prefer Nivolumab SC at the Second Assessment of Patient Preference Using PEPQ (Question 1)	Up to 24 hours after fourth full dose at Cycle 5, Day 15 (140 Days)
Number of Participants with Adverse Events (AEs)	Up to 100 days following last dose of nivolumab (Up to Day 465)

Trial Locations

Locations (3)

Local Institution - 0001; 🇩🇪 Berlin, Germany

Local Institution - 0002; 🇪🇸 Sevilla, Spain

Local Institution - 0020; 🇩🇪 Essen, North Rhine-Westphalia, Germany