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

Melanoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162123
• Other study ID #: CA184-025
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: June 28, 2016
• Start date: May 2006
• Est. completion date: April 2014

Study information

• Verified date: June 2016
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: April 2014
• Est. primary completion date: September 2012
• 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

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• Ipilimumab
Intravenous solution, 0.3, 3, or 10 mg/kg; 1 dose every 3 weeks or every 3 months until patient discontinuation

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Austria	Local Institution	Wels
Austria	Local Institution	Wien
Belgium	Local Institution	Brussels
Belgium	Local Institution	Brussels
Belgium	Local Institution	Bruxelles
Brazil	Local Institution	Jau	Sao Paulo
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Moncton	New Brunswick
Czech Republic	Local Institution	Olomouc
Denmark	Local Institution	Aarhus C
France	Local Institution	Brest
France	Local Institution	Lyon Cedex 08
France	Local Institution	Paris
France	Local Institution	Vandoeuvre Les Nancy
Germany	Local Institution	Berlin
Germany	Local Institution	Heidelberg
Germany	Local Institution	Kiel
Israel	Local Institution	Jerusalem
Israel	Local Institution	Tel-Aviv
Italy	Local Institution	Genova
Italy	Local Institution	Meldola (Fc)
Italy	Local Institution	Rimini
Italy	Local Institution	Siena
Norway	Local Institution	Oslo
Poland	Local Institution	Lodz
Poland	Local Institution	Poznan
Poland	Local Institution	Wroclaw
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	Stavropol
Russian Federation	Local Institution	Voronezh
South Africa	Local Institution	Cape Town	Western Cape
South Africa	Local Institution	Johannesburg	Gauteng
Spain	Local Institution	Malaga
Spain	Local Institution	Valencia
Ukraine	Local Institution	Dnepropetrovsk
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	University Of Chicago	Chicago	Illinois
United States	The Christ Hospital Cancer Center Research	Cincinnati	Ohio
United States	Center For Oncology Research & Treatment, P.A.	Dallas	Texas
United States	Cancer Centers Of The Carolinas	Greenville	South Carolina
United States	Indiana Oncology Hematology Consultants	Indianapolis	Indiana
United States	Baptist Cancer Institute	Jacksonville	Florida
United States	Wilshire Oncology Medical Group Inc	Laverne	California
United States	The Angeles Clinic & Research Inst.	Los Angeles	California
United States	Usc/Norris Comprehensive Cancer Center	Los Angeles	California
United States	Joe Arrington Cancer Research And Treatment Center	Lubbock	Texas
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Providence Portland Medical Center	Portland	Oregon
United States	Washington University School Of Medicine	Saint Louis	Missouri
United States	San Francisco Oncology Associates	San Francisco	California
United States	University Of Washington Medical Center	Seattle	Washington
United States	St Joseph Oncology Inc	St Joseph	Missouri
United States	Local Institution	To come	Connecticut
United States	University Of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Belgium,  Brazil,  Canada,  Czech Republic,  Denmark,  France,  Germany,  Israel,  Italy,  Norway,  Poland,  Russian Federation,  South Africa,  Spain,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	From first dose of study drug in parent study to death or date of last censoring.
Secondary	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.	From first dose of study drug in parent study to up to 2 years after reinduction
Secondary	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.	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
Secondary	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.	From day of first reinduction in current study to date of progression or death, whichever occurred first.

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form