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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 2

Conditions: Melanoma; Urothelial Carcinoma

Treatments: Drug: Nivolumab/rHuPH20; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05496192

CA209-6L6

2022-000294-67 (EudraCT Number)

U1111-1273-4725 (Registry Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Nivolumab IV followed by Nivolumab SC

Experimental group

Treatment:

Drug: Nivolumab

Drug: Nivolumab/rHuPH20