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

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ipilimumab
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Angeles Clinic And Research Institute
  • University Of California Los Angeles
  • Baptist Cancer Institute
  • Orlando Health, Inc
  • Oncology Specialists, S.C.
  • Memorial Sloan Kettering Cancer Center
  • Levine Cancer Institute
  • Duke University Hospital
  • Providence Portland Medical Center
  • St. Luke's Cancer Center - Anderson Campus
  • Seattle Cancer Care Alliance
  • Local Institution
  • Fundacion Cidea
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
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  • Local Institution
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  • Local Institution
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  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Instituto Valenciano De Oncologia
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: Ipilimumab (3 mg/kg)

Arm 2: Ipilimumab (10 mg/kg)

Arm Description

Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity

Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 18, 2012
Last Updated
July 29, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01515189
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 17, 2012 (Actual)
Primary Completion Date
February 6, 2016 (Actual)
Study Completion Date
August 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
831 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Ipilimumab (3 mg/kg)
Arm Type
Experimental
Arm Description
Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
Arm Title
Arm 2: Ipilimumab (10 mg/kg)
Arm Type
Experimental
Arm Description
Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses; option for Re-induction, until disease progression or unacceptable toxicity
Intervention Type
Biological
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy, BMS-734016
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
Approximately 48 months (assessed up to February 2016)
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS) by mWHO Criteria
Description
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.
Time Frame
From date of randomization until 540 death events occurred (approximately 48 months)
Title
Best Overall Response Rate (BORR) by mWHO Criteria
Description
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.
Time Frame
From date of randomization until 540 death events occurred (approximately 48 months)
Title
Disease Control Rate (DCR) by mWHO Criteria
Description
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.
Time Frame
From date of randomization until 540 death events occurred (approximately 48 months)
Title
Duration of Response (DOR) by mWHO Criteria
Description
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.
Time Frame
From date of randomization until 540 death events occurred (approximately 48 months)
Title
Duration of Stable Disease by mWHO Criteria
Description
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.
Time Frame
From date of randomization until 540 death events occurred (approximately 48 months)
Title
Rate of Overall Survival
Description
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.
Time Frame
Approximately 66 months
Title
Overall Survival of Participants With Brain Metastases at Baseline
Description
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.
Time Frame
From date of randomization until 540 death events occurred (approximately 48 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
The Angeles Clinic And Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
University Of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Orlando Health, Inc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Oncology Specialists, S.C.
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
St. Luke's Cancer Center - Anderson Campus
City
Easton
State/Province
Pennsylvania
ZIP/Postal Code
18045
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution
City
San Miguel De Tucuman
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Fundacion Cidea
City
Buenos Aires
ZIP/Postal Code
1121
Country
Argentina
Facility Name
Local Institution
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Local Institution
City
Coffs Harbour
State/Province
New South Wales
ZIP/Postal Code
2450
Country
Australia
Facility Name
Local Institution
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Local Institution
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Local Institution
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Local Institution
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Local Institution
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Halfax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W1S6
Country
Canada
Facility Name
Local Institution
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Local Institution
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Local Institution
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Local Institution
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Local Institution
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Local Institution
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Local Institution
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Local Institution
City
Reims Cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Local Institution
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Local Institution
City
Buxtehude
ZIP/Postal Code
21614
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Local Institution
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Local Institution
City
Munich
ZIP/Postal Code
81675
Country
Germany
Facility Name
Local Institution
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Local Institution
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Local Institution
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
71908
Country
Israel
Facility Name
Local Institution
City
Meldola (fc)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Leon, Guanajato
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Local Institution
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Local Institution
City
Leiden
ZIP/Postal Code
2300 RC
Country
Netherlands
Facility Name
Local Institution
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Local Institution
City
Oslo
ZIP/Postal Code
0379
Country
Norway
Facility Name
Local Institution
City
Gdansk
ZIP/Postal Code
80-219
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Local Institution
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Local Institution
City
George
State/Province
Western CAPE
ZIP/Postal Code
6530
Country
South Africa
Facility Name
Local Institution
City
Rondebosch
State/Province
Western CAPE
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution
City
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Instituto Valenciano De Oncologia
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Local Institution
City
Gothenberg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Local Institution
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Local Institution
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Local Institution
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Local Institution
City
Manchester
State/Province
Greater Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow, Scotland
State/Province
Strathclyde
ZIP/Postal Code
G12 OYN
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
Local Institution
City
Swansea
ZIP/Postal Code
SA2 8QA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32503946
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. Erratum In: J Immunother Cancer. 2020 Jul;8(2):
Results Reference
derived
PubMed Identifier
31334596
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.
Results Reference
derived
PubMed Identifier
28359784
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.
Results Reference
derived
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting

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

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