Phase 3 Trial in Subjects With Metastatic Melanoma Comparing 3 mg/kg Ipilimumab Versus 10 mg/kg Ipilimumab

Melanoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515189
• Other study ID #: CA184-169
• Secondary ID: 2011-004029-28
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2012
• Est. completion date: August 17, 2017

Study information

• Verified date: July 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 831
• Est. completion date: August 17, 2017
• Est. primary completion date: February 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Biological:
• Ipilimumab

Locations

Country	Name	City	State
Argentina	Fundacion Cidea	Buenos Aires
Argentina	Local Institution	San Miguel De Tucuman	Tucuman
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Brisbane	Queensland
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Coffs Harbour	New South Wales
Australia	Local Institution	Heidelberg	Victoria
Australia	Local Institution	Southport	Queensland
Austria	Local Institution	Linz
Austria	Local Institution	Vienna
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Leuven
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Halfax	Nova Scotia
Canada	Local Institution	Montreal	Quebec
Czechia	Local Institution	Brno
Czechia	Local Institution	Olomouc
Czechia	Local Institution	Praha 2
Denmark	Local Institution	Aarhus
Denmark	Local Institution	Herlev
Denmark	Local Institution	Odense
France	Local Institution	Bordeaux
France	Local Institution	Dijon Cedex
France	Local Institution	Grenoble
France	Local Institution	Lille
France	Local Institution	Marseille Cedex 5
France	Local Institution	Nantes Cedex 1
France	Local Institution	Paris
France	Local Institution	Pierre Benite
France	Local Institution	Reims Cedex
France	Local Institution	Toulouse
France	Local Institution	Villejuif
Germany	Local Institution	Buxtehude
Germany	Local Institution	Essen
Germany	Local Institution	Hannover
Germany	Local Institution	Heidelberg
Germany	Local Institution	Kiel
Germany	Local Institution	Mainz
Germany	Local Institution	Munich
Germany	Local Institution	Tubingen
Hungary	Local Institution	Budapest
Hungary	Local Institution	Kaposvar
Hungary	Local Institution	Szeged
Israel	Local Institution	Jerusalem
Italy	Local Institution	Meldola (fc)
Italy	Local Institution	Milano
Italy	Local Institution	Napoli
Italy	Local Institution	Padova
Italy	Local Institution	Roma
Italy	Local Institution	Siena
Mexico	Local Institution	Leon, Guanajato	Guanajuato
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Groningen
Netherlands	Local Institution	Leiden
Norway	Local Institution	Bergen
Norway	Local Institution	Oslo
Poland	Local Institution	Gdansk
Poland	Local Institution	Poznan
Poland	Local Institution	Warszawa
South Africa	Local Institution	Cape Town	Western CAPE
South Africa	Local Institution	George	Western CAPE
South Africa	Local Institution	Rondebosch	Western CAPE
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Navarra
Spain	Instituto Valenciano De Oncologia	Valencia
Spain	Local Institution	Valencia
Sweden	Local Institution	Gothenberg
Sweden	Local Institution	Lund
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Umea
Switzerland	Local Institution	Lausanne
United Kingdom	Local Institution	Glasgow, Scotland	Strathclyde
United Kingdom	Local Institution	London
United Kingdom	Local Institution	Manchester	Greater Manchester
United Kingdom	Local Institution	Swansea
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Duke University Hospital	Durham	North Carolina
United States	St. Luke's Cancer Center - Anderson Campus	Easton	Pennsylvania
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	The Angeles Clinic And Research Institute	Los Angeles	California
United States	University Of California Los Angeles	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Orlando Health, Inc	Orlando	Florida
United States	Oncology Specialists, S.C.	Park Ridge	Illinois
United States	Providence Portland Medical Center	Portland	Oregon
United States	Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Canada,  Czechia,  Denmark,  France,  Germany,  Hungary,  Israel,  Italy,  Mexico,  Netherlands,  Norway,  Poland,  South Africa,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median and associated 2-sided 95% confidence intervals were calculated using the method of Brookmeyer and Crowley.	Approximately 48 months (assessed up to February 2016)
Secondary	Progression Free Survival (PFS) by mWHO Criteria	PFS was defined as the time between randomization date and the date of progression or death, whichever occurred first. A participant who died without reported prior progression was considered to have progressed on the date of death. For a participant who underwent resection post randomization, PFS was censored on last tumor assessment date prior to resection. For those who remained alive and had not progressed, PFS was censored on last evaluable tumor assessment date. Participants who had not died and had no recorded post-baseline tumor assessment were censored at the day of randomization. For participants who had Progressive Disease (PD) prior to Week 12 and a subsequent assessment of Stable Disease (SD), Partial Response (PR), or Complete Response (CR), the date of PD following response was used in the analysis of PFS; otherwise these participants were censored on the date of their last tumor assessment. Median and 2-sided 95% CIs were calculated with Brookmeyer Crowley method.	From date of randomization until 540 death events occurred (approximately 48 months)
Secondary	Best Overall Response Rate (BORR) by mWHO Criteria	BORR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR or PR, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for BOR, e.g. on account of missing or "not evaluable" assessments, was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the BORR endpoint). 95% 2-sided exact confidence intervals were computed using the method of Clopper and Pearson.	From date of randomization until 540 death events occurred (approximately 48 months)
Secondary	Disease Control Rate (DCR) by mWHO Criteria	DCR by treatment arm was defined as the total number of randomized participants in the arm whose BOR is CR, PR or SD, divided by the total number of randomized participants in the arm. Any participant who was unevaluable for Disease Control (DC), (e.g. on account of missing or "not evaluable" assessments), was included in the denominator of the calculation (i.e. was considered a non-responder with respect to the DCR endpoint). 95% 2-sided exact confidence intervals were computed using the Clopper and Pearson method.	From date of randomization until 540 death events occurred (approximately 48 months)
Secondary	Duration of Response (DOR) by mWHO Criteria	Duration of response for participants whose BOR was CR or PR was defined as the time between the date measurement criteria were first met for overall response of PR or CR (whichever status was recorded first) and the date of disease progression or death (whichever occurred first). For participants who underwent tumor resection following response but prior to disease progression, duration of response was censored on the date of last evaluable tumor assessment prior to resection. For participants who had BOR of SD, PR or CR at Week 12, or a confirmed response of PR or CR before Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of response. For those participants who remained alive and had not progressed following response, duration of response was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer Crowley method.	From date of randomization until 540 death events occurred (approximately 48 months)
Secondary	Duration of Stable Disease by mWHO Criteria	Duration of stable disease was defined for participants whose BOR was SD as the time between when SD was first documented and the date of PD or death (whichever occurred first). For a participant who underwent tumor resection following Week 12 but prior to disease progression, duration of stable disease was censored on the date of the last evaluable tumor assessment prior to resection. For participants who had BOR of SD at Week 12, the date of PD following thereafter (where available) was used in the analysis of duration of stable disease. For participants with BOR of SD who had not subsequently progressed and who remained alive, duration of stable disease was censored on the date of last evaluable tumor assessment. Median and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.	From date of randomization until 540 death events occurred (approximately 48 months)
Secondary	Rate of Overall Survival	OS is defined for each participant as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Survival rates were calculated based on Kaplan-Meier estimation with log-log transformed confidence intervals. The survival rate at x year(s) is defined as the probability that a subject is alive at x year(s) following randomization.	Approximately 66 months
Secondary	Overall Survival of Participants With Brain Metastases at Baseline	OS for each participant with brain metastases at baseline was measured as the time between randomization date and death due to any cause. The survival time for participants who had not died was censored at the last known alive date. Median OS, and associated 2-sided 95% confidence intervals were calculated using the Brookmeyer and Crowley method.	From date of randomization until 540 death events occurred (approximately 48 months)

External Links

•   BMS Clinical Trial Patient Recruiting
•   Investigator Inquiry Form