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

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05496192

Collaborator

(none)

Enrollment

Location

Arm

44.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma Urothelial Carcinoma	Drug: Nivolumab/rHuPH20 Drug: Nivolumab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Adjuvant Nivolumab Switch From Intravenous (IV) to Subcutaneous (SC) Use in Participants With Resected Stage III or Stage IV Melanoma or High Risk Invasive Urothelial Carcinoma Originating in the Bladder

Anticipated Study Start Date :

Oct 11, 2022

Anticipated Primary Completion Date :

Jun 24, 2024

Anticipated Study Completion Date :

Jun 24, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nivolumab IV followed by Nivolumab SC	Drug: Nivolumab/rHuPH20 Specified dose on specified days Other Names: Opdivo BMS-986298 Drug: Nivolumab Specified dose on specified days Other Names: Opdivo BMS-936558

Arm

Intervention/Treatment

Experimental: Nivolumab IV followed by Nivolumab SC

Drug: Nivolumab/rHuPH20

Specified dose on specified days

Other Names:

Opdivo

BMS-986298

Drug: Nivolumab

Specified dose on specified days

Other Names:

Opdivo

BMS-936558

Outcome Measures

Primary Outcome Measures

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

Number of Participants with Adverse Events (AEs) [Up to 100 days following last dose of nivolumab (Up to Day 465)]
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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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