Clinical trial NCT01515189: Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab
Official title: A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or 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: 2012-01-24
Enrollment: 831
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 determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Unresectable Stage III or Stage IV melanoma
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Brain metastases with symptoms or requiring treatment
* History of autoimmune disease

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 48 months (assessed up to February 2016)
Secondary outcomes:
measure: Progression Free Survival (PFS) by mWHO Criteria
timeFrame: From date of randomization until 540 death events occurred (approximately 48 months)
measure: Best Overall Response Rate (BORR) by mWHO Criteria
timeFrame: From date of randomization until 540 death events occurred (approximately 48 months)
measure: Disease Control Rate (DCR) by mWHO Criteria
timeFrame: From date of randomization until 540 death events occurred (approximately 48 months)
measure: Duration of Response (DOR) by mWHO Criteria
timeFrame: From date of randomization until 540 death events occurred (approximately 48 months)
measure: Duration of Stable Disease by mWHO Criteria
timeFrame: From date of randomization until 540 death events occurred (approximately 48 months)
measure: Rate of Overall Survival
timeFrame: Approximately 66 months
measure: Overall Survival of Participants With Brain Metastases at Baseline
timeFrame: From date of randomization until 540 death events occurred (approximately 48 months)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinic And Research Institute
state: California
city: Los Angeles
country: United States
facility: University Of California Los Angeles
state: California
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Health, Inc
state: Florida
city: Park Ridge
country: United States
facility: Oncology Specialists, S.C.
state: Illinois
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute
state: North Carolina
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Easton
country: United States
facility: St. Luke's Cancer Center - Anderson Campus
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Fundacion Cidea
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Local Institution
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution
state: Queensland
city: Southport
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Linz
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Halfax
country: Canada
facility: Local Institution
state: Nova Scotia
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Brno
country: Czechia
facility: Local Institution
city: Olomouc
country: Czechia
facility: Local Institution
city: Praha 2
country: Czechia
facility: Local Institution
city: Aarhus
country: Denmark
facility: Local Institution
city: Herlev
country: Denmark
facility: Local Institution
city: Odense
country: Denmark
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Dijon Cedex
country: France
facility: Local Institution
city: Grenoble
country: France
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Marseille Cedex 5
country: France
facility: Local Institution
city: Nantes Cedex 1
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Pierre Benite
country: France
facility: Local Institution
city: Reims Cedex
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Villejuif
country: France
facility: Local Institution
city: Buxtehude
country: Germany
facility: Local Institution
city: Essen
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Mainz
country: Germany
facility: Local Institution
city: Munich
country: Germany
facility: Local Institution
city: Tubingen
country: Germany
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Kaposvar
country: Hungary
facility: Local Institution
city: Szeged
country: Hungary
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Meldola (fc)
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Leon, Guanajato
country: Mexico
facility: Local Institution
state: Guanajuato
city: Amsterdam
country: Netherlands
facility: Local Institution
city: Groningen
country: Netherlands
facility: Local Institution
city: Leiden
country: Netherlands
facility: Local Institution
city: Bergen
country: Norway
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Gdansk
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Cape Town
country: South Africa
facility: Local Institution
state: Western CAPE
city: George
country: South Africa
facility: Local Institution
state: Western CAPE
city: Rondebosch
country: South Africa
facility: Local Institution
state: Western CAPE
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Navarra
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Instituto Valenciano De Oncologia
city: Valencia
country: Spain
facility: Local Institution
city: Gothenberg
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Umea
country: Sweden
facility: Local Institution
city: Lausanne
country: Switzerland
facility: Local Institution
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Glasgow, Scotland
country: United Kingdom
facility: Local Institution
state: Strathclyde
city: London
country: United Kingdom
facility: Local Institution
city: Swansea
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Ascierto PA, Del Vecchio M, Mackiewicz A, Robert C, Chiarion-Sileni V, Arance A, Lebbe C, Svane IM, McNeil C, Rutkowski P, Loquai C, Mortier L, Hamid O, Bastholt L, Dreno B, Schadendorf D, Garbe C, Nyakas M, Grob JJ, Thomas L, Liszkay G, Smylie M, Hoeller C, Ferraresi V, Grange F, Gutzmer R, Pikiel J, Hosein F, Simsek B, Maio M. Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma. J Immunother Cancer. 2020 Jun;8(1):e000391. doi: 10.1136/jitc-2019-000391.
citation: Feng Y, Wang X, Suryawanshi S, Bello A, Roy A. Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling. CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):825-834. doi: 10.1002/psp4.12454. Epub 2019 Aug 13.
citation: Ascierto PA, Del Vecchio M, Robert C, Mackiewicz A, Chiarion-Sileni V, Arance A, Lebbe C, Bastholt L, Hamid O, Rutkowski P, McNeil C, Garbe C, Loquai C, Dreno B, Thomas L, Grob JJ, Liszkay G, Nyakas M, Gutzmer R, Pikiel J, Grange F, Hoeller C, Ferraresi V, Smylie M, Schadendorf D, Mortier L, Svane IM, Hennicken D, Qureshi A, Maio M. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2017 May;18(5):611-622. doi: 10.1016/S1470-2045(17)30231-0. Epub 2017 Mar 27.