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

Bristol-Myers Squibb

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Melanoma Urothelial Carcinoma

Interventions

Nivolumab/rHuPH20DRUG

Specified dose on specified days

NivolumabDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Local Institution - 0020

Essen, North Rhine-Westphalia, Germany

Local Institution - 0001

Berlin, Germany

Local Institution - 0002

Seville, Spain

Outcomes

Primary Outcomes

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)

Secondary Outcomes

Number of Participants with Adverse Events (AEs)

Time frame: 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)

Time frame: Up to 24 hours after fourth full dose at Cycle 5, Day 15 (140 Days)

Data from ClinicalTrials.gov

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