Clinical trial NCT05297565: A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection
Official title: A Phase 3, Open Label, Randomized, Non-Inferiority Pharmacokinetic Study of Nivolumab Subcutaneous (Nivo SC) Versus Intravenous (Nivo IV) Administration in Participants With Stage IIIA/B/C/D or Stage IV Adjuvant Melanoma Following Complete Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Keywords: Skin Cancer
rHuPH20
OPDIVO®
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of subcutaneous nivolumab vs intravenous nivolumab in participants with completely resected Stage IIIA/B/C/D or Stage IV melanoma.


Eligibility criteria: Inclusion Criteria:

* Stage IIIA/B/C/D or Stage IV melanoma and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins
* Complete resection performed within 12 weeks prior to randomization or treatment assignment
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1

Exclusion Criteria:

* History of uveal or mucosal melanoma
* Untreated/unresected CNS metastases or leptomeningeal metastases
* Active, known or suspected autoimmune disease
* Serious or uncontrolled medical disorder 4 weeks prior to screening
* Concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to randomization or treatment assignment. Participants with history of prior early stage basal/squamous cell skin cancer or non-invasive or in situ cancers that have undergone definitive treatment at any time are eligible
* Prior immunotherapy treatments for any prior malignancies are not permitted

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose to 100 days post last dose (Approximately up to 14 Months)
measure: Number of Participants With Serious Adverse Events
timeFrame: From first dose to 100 days post last dose (Approximately up to 14 Months)
measure: Number of Participants With Treatment Related Adverse Events
timeFrame: From first dose to 100 days post last dose (Approximately up to 14 Months)
measure: Number of Participants With Treatment Related Serious Adverse Events
timeFrame: From first dose to 100 days post last dose (Approximately up to 14 Months)
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Local Institution - 0004
state: Indiana
city: Knoxville
country: United States
facility: Local Institution - 0044
state: Tennessee
city: Coffs Harbour
country: Australia
facility: Local Institution - 0038
state: New South Wales
city: Wollongong
country: Australia
facility: Local Institution - 0003
state: New South Wales
city: Bendigo
country: Australia
facility: Local Institution - 0008
state: Victoria
city: Gent
country: Belgium
facility: Local Institution - 0029
city: Milano
country: Italy
facility: Local Institution - 0016
city: Napoli
country: Italy
facility: Local Institution - 0015
city: Opole
country: Poland
facility: Local Institution - 0034
state: Opolskie
city: Bydgoszcz
country: Poland
facility: Local Institution - 0036
city: Barcelona
country: Spain
facility: Local Institution - 0026
city: Madrid
country: Spain
facility: Local Institution - 0002
city: Madrid
country: Spain
facility: Local Institution - 0043
city: Sevilla
country: Spain
facility: Local Institution - 0005
city: Valencia
country: Spain
facility: Local Institution - 0030
city: Leicester
country: United Kingdom
facility: Local Institution - 0040
state: Leicestershire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: