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A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

Primary Purpose

Melanoma

Status
Completed
Phase
Phase 2
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 focused on measuring ipilimumab, previously treated

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 Key Inclusion Criteria Diagnosis of advanced melanoma Prior treatment in a prespecified prior/parent ipilimumab study Men and women 18 years of age and older First Reinduction: No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation Had experienced documented progressive disease after expanded clinical benefit Extended Maintenance Received ipilimumab at any dose in a parent study Achieved expanded clinical benefit at the time of entry to current study Follow-up: Received ipilimumab at any dose in a closing parent study Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up Key Exclusion Criteria Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab Primary ocular or mucosal melanoma

Sites / Locations

  • University Of Arizona Cancer Center
  • Wilshire Oncology Medical Group Inc
  • The Angeles Clinic & Research Inst.
  • Usc/Norris Comprehensive Cancer Center
  • San Francisco Oncology Associates
  • Local Institution
  • Baptist Cancer Institute
  • University Of Chicago
  • Indiana Oncology Hematology Consultants
  • Washington University School Of Medicine
  • St Joseph Oncology Inc
  • Memorial Sloan Kettering Cancer Center
  • Carolinas Medical Center
  • The Christ Hospital Cancer Center Research
  • Providence Portland Medical Center
  • Cancer Centers Of The Carolinas
  • Center For Oncology Research & Treatment, P.A.
  • Joe Arrington Cancer Research And Treatment Center
  • University Of Washington Medical Center
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • 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 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

No Intervention

Arm Label

First reinduction: Ipilimumab, 0.3 to 10 mg/kg

First reinduction: Ipilimumab, 3 to 10 mg/kg

First reinduction: Ipilimumab, 10 to 10 mg/kg

Extended maintenance: Ipilimumab, 0.3 mg/kg

Extended maintenance: Ipilimumab, 3 mg/kg

Extended maintenance: Ipilimumab, 10 mg

Follow-up

Arm Description

Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.

Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.

Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.

Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.

Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.

Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.

Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.

Outcomes

Primary Outcome Measures

Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Secondary Outcome Measures

Overall Survival (OS)
OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.
Percentage of Participants Surviving at 1, 1.5, and 2 Years
Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.
Number of Participants With On-study Immune-related Adverse Events (irAEs)
irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.
Progression-free Survival (PFS)
PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.

Full Information

First Posted
September 9, 2005
Last Updated
June 28, 2016
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00162123
Brief Title
A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
Official Title
A Multi-Center, Open-Label, Phase II Study of Ipilimumab (MDX-010 Extended-Treatment Monotherapy or Follow-up for Patients Previously Enrolled in Ipilimumab (MDX-010) Protocols.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
April 2014 (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 was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
ipilimumab, previously treated

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
First reinduction: Ipilimumab, 0.3 to 10 mg/kg
Arm Type
Experimental
Arm Description
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Arm Title
First reinduction: Ipilimumab, 3 to 10 mg/kg
Arm Type
Experimental
Arm Description
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Arm Title
First reinduction: Ipilimumab, 10 to 10 mg/kg
Arm Type
Experimental
Arm Description
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Arm Title
Extended maintenance: Ipilimumab, 0.3 mg/kg
Arm Type
Experimental
Arm Description
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Arm Title
Extended maintenance: Ipilimumab, 3 mg/kg
Arm Type
Experimental
Arm Description
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Arm Title
Extended maintenance: Ipilimumab, 10 mg
Arm Type
Experimental
Arm Description
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Arm Title
Follow-up
Arm Type
No Intervention
Arm Description
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
BMS-734016, MDX-010
Intervention Description
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation
Primary Outcome Measure Information:
Title
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
Description
An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Time Frame
Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.
Time Frame
From first dose of study drug in parent study to death or date of last censoring.
Title
Percentage of Participants Surviving at 1, 1.5, and 2 Years
Description
Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.
Time Frame
From first dose of study drug in parent study to up to 2 years after reinduction
Title
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Description
irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.
Time Frame
From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date
Title
Progression-free Survival (PFS)
Description
PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.
Time Frame
From day of first reinduction in current study to date of progression or death, whichever occurred first.

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 Key Inclusion Criteria Diagnosis of advanced melanoma Prior treatment in a prespecified prior/parent ipilimumab study Men and women 18 years of age and older First Reinduction: No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation Had experienced documented progressive disease after expanded clinical benefit Extended Maintenance Received ipilimumab at any dose in a parent study Achieved expanded clinical benefit at the time of entry to current study Follow-up: Received ipilimumab at any dose in a closing parent study Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up Key Exclusion Criteria Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab Primary ocular or mucosal melanoma
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
University Of Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Wilshire Oncology Medical Group Inc
City
Laverne
State/Province
California
ZIP/Postal Code
91750
Country
United States
Facility Name
The Angeles Clinic & Research Inst.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Usc/Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
San Francisco Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Local Institution
City
To come
State/Province
Connecticut
Country
United States
Facility Name
Baptist Cancer Institute
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University Of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana Oncology Hematology Consultants
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Washington University School Of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St Joseph Oncology Inc
City
St Joseph
State/Province
Missouri
ZIP/Postal Code
64507
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
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
The Christ Hospital Cancer Center Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Cancer Centers Of The Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Center For Oncology Research & Treatment, P.A.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Joe Arrington Cancer Research And Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
University Of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
CP1280AEB
Country
Argentina
Facility Name
Local Institution
City
Wels
ZIP/Postal Code
A-4600
Country
Austria
Facility Name
Local Institution
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610
Country
Brazil
Facility Name
Local Institution
City
Jau
State/Province
Sao Paulo
ZIP/Postal Code
17210
Country
Brazil
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Local Institution
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Local Institution
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Facility Name
Local Institution
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Local Institution
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
Local Institution
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Local Institution
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Local Institution
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Local Institution
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution
City
Meldola (Fc)
ZIP/Postal Code
47014
Country
Italy
Facility Name
Local Institution
City
Rimini
ZIP/Postal Code
47900
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
90553
Country
Poland
Facility Name
Local Institution
City
Poznan
ZIP/Postal Code
61-866
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
191104
Country
Russian Federation
Facility Name
Local Institution
City
Stavropol
ZIP/Postal Code
355047
Country
Russian Federation
Facility Name
Local Institution
City
Voronezh
ZIP/Postal Code
394000
Country
Russian Federation
Facility Name
Local Institution
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2199
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Local Institution
City
Dnepropetrovsk
ZIP/Postal Code
49044
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
25210016
Citation
Lebbe C, Weber JS, Maio M, Neyns B, Harmankaya K, Hamid O, O'Day SJ, Konto C, Cykowski L, McHenry MB, Wolchok JD. Survival follow-up and ipilimumab retreatment of patients with advanced melanoma who received ipilimumab in prior phase II studies. Ann Oncol. 2014 Nov;25(11):2277-2284. doi: 10.1093/annonc/mdu441. Epub 2014 Sep 10.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

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