Clinical trial NCT06101134: A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations
Official title: A Phase 2 Open-label, Two-cohort Study to Evaluate Patient Preference for Nivolumab + Relatlimab Fixed-dose Combination Subcutaneous Versus Nivolumab + Relatlimab Fixed-dose Combination Intravenous and Nivolumab Subcutaneous Versus Nivolumab Intravenous in Participants With Melanoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Melanoma
Keywords: Patient preference
Nivolumab Relatlimab IV
Nivolumab Relatimab SC
Melanoma
rHuPH20
FDC IV
FDC SC
Adjuvant
Metastatic
Switch
Nivolumab
Relatlimab
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the patient's preference for nivolumab subcutaneous (SC) or nivolumab + relatlimab fixed-dose combination (FDC) SC and provide patient experience data by route of administration. This study will also generate safety data which will further characterize the safety profile of patients switching the route of administration from intravenous (IV) to SC.


Eligibility criteria: Inclusion Criteria:

* Must have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease
* Must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma

Exclusion Criteria:

* Must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body's immune system response (immunosuppressive drugs)

Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Number of participants that prefer subcutaneous (SC) route of administration as assessed by Question 7 of the Patient Experience and Preference Questionnaire (PEPQ)
timeFrame: At Cycle 4 Day 1 (each cycle is 28 days)
Secondary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to approximately 2.5 years
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Up to approximately 2.5 years
measure: Number of participants with treatment-related AEs
timeFrame: Up to approximately 2.5 years
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to approximately 2.5 years
measure: Number of participants with Immune-mediated AEs (IMAEs)
timeFrame: Up to approximately 2.5 years
measure: Number of participants with other events of special interest (OESIs)
timeFrame: Up to approximately 2.5 years
measure: Number of participants with injection/infusion-related AEs
timeFrame: Up to approximately 2.5 years
measure: Number of deaths
timeFrame: Up to approximately 2.5 years
measure: Number of participants with laboratory abnormalities
timeFrame: Up to approximately 2.5 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Local Institution - 0007
state: Alaska
city: Phoenix
country: United States
facility: Local Institution - 0013
state: Arizona
city: San Francisco
country: United States
facility: Local Institution - 0010
state: California
city: Atlanta
country: United States
facility: Local Institution - 0034
state: Georgia
city: Edgewood
country: United States
facility: Local Institution - 0032
state: Kentucky
city: Albuquerque
country: United States
facility: Local Institution - 0028
state: New Mexico
city: Edmonds
country: United States
facility: Local Institution - 0037
state: Washington
city: Issaquah
country: United States
facility: Local Institution - 0036
state: Washington
city: Seattle
country: United States
facility: Local Institution - 0030
state: Washington
city: Las Condes
country: Chile
facility: Local Institution - 0015
state: Santiago
city: Concepcion
country: Chile
facility: Local Institution - 0005
city: Thessaloniki
country: Greece
facility: Local Institution - 0019
state: B
city: Athens
country: Greece
facility: Local Institution - 0014
state: I
city: Marousi
country: Greece
facility: Local Institution - 0029
state: I
city: Holargos, Athens
country: Greece
facility: Local Institution - 0023
city: Peiraias
country: Greece
facility: Local Institution - 0008
city: Thessaloniki
country: Greece
facility: Local Institution - 0033
city: Bergamo
country: Italy
facility: Local Institution - 0017
state: BG
city: Meldola
country: Italy
facility: Local Institution - 0035
state: FC
city: Milan
country: Italy
facility: Local Institution - 0018
state: MI
city: Padova
country: Italy
facility: Local Institution - 0012
state: PD
city: Roma
country: Italy
facility: Local Institution - 0021
state: RM
city: Torino
country: Italy
facility: Local Institution - 0004
state: TO
city: Napoli
country: Italy
facility: Local Institution - 0026
city: Barcelona
country: Spain
facility: Local Institution - 0011
state: B
city: Barcelona
country: Spain
facility: Local Institution - 0022
state: B
city: Cartagena
country: Spain
facility: Local Institution - 0009
state: MU
city: Badalona
country: Spain
facility: Local Institution - 0020
city: Cantabria
country: Spain
facility: Local Institution - 0027
city: San Pedro Alcántara, Málaga
country: Spain
facility: Local Institution - 0003
city: Sevilla
country: Spain
facility: Local Institution - 0006
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: