Clinical trial NCT00162123: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: ipilimumab
previously treated
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: 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 outcomes:
measure: Overall Survival (OS)
timeFrame: From first dose of study drug in parent study to death or date of last censoring.
measure: Percentage of Participants Surviving at 1, 1.5, and 2 Years
timeFrame: From first dose of study drug in parent study to up to 2 years after reinduction
measure: Number of Participants With On-study Immune-related Adverse Events (irAEs)
timeFrame: 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
measure: Progression-free Survival (PFS)
timeFrame: From day of first reinduction in current study to date of progression or death, whichever occurred first.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University Of Arizona Cancer Center
state: Arizona
city: Laverne
country: United States
facility: Wilshire Oncology Medical Group Inc
state: California
city: Los Angeles
country: United States
facility: The Angeles Clinic & Research Inst.
state: California
city: Los Angeles
country: United States
facility: Usc/Norris Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: San Francisco Oncology Associates
state: California
city: To come
country: United States
facility: Local Institution
state: Connecticut
city: Jacksonville
country: United States
facility: Baptist Cancer Institute
state: Florida
city: Chicago
country: United States
facility: University Of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Oncology Hematology Consultants
state: Indiana
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: St Joseph
country: United States
facility: St Joseph Oncology Inc
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital Cancer Center Research
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Greenville
country: United States
facility: Cancer Centers Of The Carolinas
state: South Carolina
city: Dallas
country: United States
facility: Center For Oncology Research & Treatment, P.A.
state: Texas
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research And Treatment Center
state: Texas
city: Seattle
country: United States
facility: University Of Washington Medical Center
state: Washington
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Wels
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Brussels
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Jau
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Moncton
country: Canada
facility: Local Institution
state: New Brunswick
city: Olomouc
country: Czech Republic
facility: Local Institution
city: Aarhus C
country: Denmark
facility: Local Institution
city: Brest
country: France
facility: Local Institution
city: Lyon Cedex 08
country: France
facility: Local Institution
city: Paris
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Jerusalem
country: Israel
facility: Local Institution
city: Tel-Aviv
country: Israel
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Meldola (Fc)
country: Italy
facility: Local Institution
city: Rimini
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Oslo
country: Norway
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Stavropol
country: Russian Federation
facility: Local Institution
city: Voronezh
country: Russian Federation
facility: Local Institution
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Malaga
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Dnepropetrovsk
country: Ukraine
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.