Clinical trial NCT02714218: A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma
Official title: Phase IIIb/IV, Randomized, Double Blinded, Study of Nivolumab 3 mg/kg in Combination With Ipilimumab 1 mg/kg vs Nivolumab 1 mg/kg in Combination With Ipilimumab 3 mg/kg 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: 2016-03-21
Enrollment: 387
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 evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.


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

Inclusion Criteria:

* Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma \[per American Joint Committee on Cancer (AJCC) staging system\] that is unresectable or metastatic
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Subject has 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: The Percentage of Participants With Drug-Related Grade 3 - 5 Adverse Events (AEs)
timeFrame: From first dose of study treatment up to primary completion date 20-Apr-2017 (up to approximately 12 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From date of randomization to date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 5 years)
measure: Overall Survival (OS)
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up tp approximately 5 years)
measure: Progression Free Survival (PFS)
timeFrame: From randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 5 years)
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Physical Functioning Scale
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Role Functioning Scale
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Emotional Functioning Scale
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Cognitive Functioning Scale
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Social Functioning Scale
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Global Health Status
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Dyspnea
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Insomnia
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Appetite Loss
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Constipation
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Diarrhea
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Financial Difficulties
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Fatigue
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Nausea and Vomiting
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
measure: Mean Changes From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-30) Pain
timeFrame: Weeks 7, 16, 20, 24, 28, 32, 36, 40
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University Of Colorado Cancer Center
state: Colorado
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Fridley
country: United States
facility: Allina Health
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Charlottesville
country: United States
facility: University Of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: University of Washington - Seattle Cancer Care Alliance
state: Washington
city: North Sydney
country: Australia
facility: Local Institution
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution - 0045
state: New South Wales
city: Greenslopes
country: Australia
facility: Local Institution
state: Queensland
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Edmonton
country: Canada
facility: Local Institution - 0007
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Quebec
country: Canada
facility: CHU de Quebec - Universite Laval
city: Aarhus N
country: Denmark
facility: Local Institution - 0063
city: Herlev
country: Denmark
facility: Local Institution - 0065
city: Odense
country: Denmark
facility: Local Institution - 0064
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Lille
country: France
facility: Chru De Lille
city: Marseille Cedex 5
country: France
facility: Hopital De La Timone
city: Nantes Cedex
country: France
facility: Hopital Hotel Dieu
city: Paris
country: France
facility: Hopital Saint Louis
city: Pierre Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Toulouse Cedex 9
country: France
facility: Institut Claudius Regaud
city: Villejuif
country: France
facility: Local Institution - 0019
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Muenchen
country: Germany
facility: Ludwig-Maximilians-Universitaet
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ramat Gan
country: Israel
facility: Local Institution
city: Bergamo
country: Italy
facility: Local Institution - 0039
city: Milano
country: Italy
facility: Local Institution - 0042
city: Napoli
country: Italy
facility: Local Institution - 0040
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IOV
city: Siena
country: Italy
facility: Local Institution - 0041
city: Taormina
country: Italy
facility: Ospedale San Vincenzo
city: Amsterdam
country: Netherlands
facility: Local Institution - 0052
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (Umcg)
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii I Radiote
city: Krakow
country: Poland
facility: Klinika Nowotworow Ukladowych i Uogolnionych
city: Warszawa
country: Poland
facility: Klinika Nowotworow Tkanek Miekkich, Kosci i Czerniakow
city: Moscow
country: Russian Federation
facility: Local Institution
city: Badalona-barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution - 0024
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution - 0027
city: San Sabastian Gipuzkoa
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Oxford
country: United Kingdom
facility: Local Institution
state: Oxfordshire
city: Guildford
country: United Kingdom
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Lebbe C, Meyer N, Mortier L, Marquez-Rodas I, Robert C, Rutkowski P, Menzies AM, Eigentler T, Ascierto PA, Smylie M, Schadendorf D, Ajaz M, Svane IM, Gonzalez R, Rollin L, Lord-Bessen J, Saci A, Grigoryeva E, Pigozzo J. Evaluation of Two Dosing Regimens for Nivolumab in Combination With Ipilimumab in Patients With Advanced Melanoma: Results From the Phase IIIb/IV CheckMate 511 Trial. J Clin Oncol. 2019 Apr 10;37(11):867-875. doi: 10.1200/JCO.18.01998. Epub 2019 Feb 27.