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

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05496192

Enrollment

Registered

2022-08-11

Start date

2023-05-31

Completion date

2026-06-24

Last updated

2023-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma, Urothelial Carcinoma

Keywords

Resected Invasive Urothelial Carcinoma, Nivolumab, Bladder, Melanoma, Adjuvant, Subcutaneous

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.

Interventions

DRUGNivolumab/rHuPH20

Specified dose on specified days

DRUGNivolumab

Specified dose on specified days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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/

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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)

Countries

Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026