Clinical trial NCT02905266: A Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Melanoma
Official title: Phase IIIb, Randomized, Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Previously Untreated Unresectable or Metastatic Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-09-19
Enrollment: 106
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: This is a safety and efficacy study of different administration regimens of nivolumab plus Ipilimumab in subjects with previously untreated, unresectable or metastatic melanoma.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Males and Females, ages 15 years ≥ of age (Except where local regulations and/or institutional policies do not allow for subjects \< 18 years of age to participate)
* Subjects must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma that is unresectable or metastatic
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Subjects have not been treated by systemic anticancer therapy for unresectable or metastatic melanoma

Exclusion Criteria:

* Subjects with active brain metastases or leptomeningeal metastases
* Subjects with ocular melanoma
* Subjects with active, known or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Percentage of Participants Affected by Adverse Events (AEs) in the Broad Scope MedDRA Anaphylactic Reaction Standardized MedDRA Queries (SMQ)
timeFrame: Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
Secondary outcomes:
measure: Percentage of Participants Affected by AEs in the Narrow Scope MedDRA Anaphylactic Reaction SMQ
timeFrame: Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
measure: Percentage of Participants Affected by Hypersensitivity/Infusion Reaction Select AEs
timeFrame: Within 2 days from administration of any of the 4 doses in part 1 period (approximately 12 weeks)
measure: Percentage of Participants Affected by All Causality Grade 3 - 5 AEs
timeFrame: From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
measure: Percentage of Participants Affected by Drug-related Grade 3 - 5 AEs
timeFrame: From initial dose of study treatment and within 30 days of the last dose of study treatment (approximately 25 months)
measure: Geometric Mean Concentration of Ipilimumab at End of Infusion (EOI)
timeFrame: From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported.
measure: Geometric Mean Concentration of Nivolumab at End of Infusion (EOI)
timeFrame: From Cycle 1, Day 1 to Cycle 4, Day 1 (approximately 9 weeks). Each cycle lasts 3 weeks. Cycle 1 day 1, Cycle 2 day 1 and Cycle 4 day 1 values reported
measure: Geometric Mean Trough Concentration of Ipilimumab
timeFrame: From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
measure: Geometric Mean Trough Concentration of Nivolumab
timeFrame: From Cycle 2, Day 1 to Cycle 4, Day 1 (approximately 6 weeks). Each cycle lasts 3 weeks.
measure: Objective Response Rate (ORR)
timeFrame: Week 12 following randomization, every 8 weeks for the first 12 months and then every 12 weeks until disease progression (approximately 20 months)
measure: Progression Free Survival (PFS)
timeFrame: From the date of randomization to the first date of documented progression (approximately 26 months)
Other outcomes:
Locations:
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Greenslopes
country: Australia
facility: Greenslopes Private Hospital
state: Queensland
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Lyon Cedex 08
country: France
facility: Local Institution
city: Marseille Cedex 5
country: France
facility: Hopital De La Timone
city: Nantes Cedex 1
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Paris
country: France
facility: Hopital Saint Louis
city: Tours
country: France
facility: Hopital Trousseau - Chru Tours
city: Genova
country: Italy
facility: Istituto Nazionale Per La Ricerca Sul Cancro - Oncologia Med
city: Meldola (FC)
country: Italy
facility: Istituto Scientifico Romagnolo Per Lo Studio E Cura Tumori
city: Milan
country: Italy
facility: Istituto Europeo Di Oncologia
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta della Salute e della Scienza
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: