Clinical trial NCT00289627: A Single Arm Study of Ipilimumab Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Official title: A Multi-Center Single Arm Phase II Study of MDX-010 (BMS-734016) Monotherapy in Patients With Previously Treated Unresectable Stage III or IV Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Melanoma
Keywords: Previously treated melanoma
Unresectable Stage III
Stage IV
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Medarex
First posted: 2006-02-10
Enrollment: 155
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 clinical research study is to evaluate the Best Overall Response Rate (BORR), (as per modified WHO criteria) in patients with previously treated melanoma-Stage III (unresectable) or Stage IV melanoma receiving 10 mg/kg of ipilimumab. The safety of this product will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients with previously treated Stage III (unresectable)or Stage IV melanoma

Primary outcomes:
measure: Evaluate BORR in patients with previously treated Stage III (unresectable) or Stage IV melanoma receiving ipilimumab.
Secondary outcomes:
measure: estimate disease control rate
measure: estimate progression free survival rate at Week 12
measure: estimate PFS
measure: estimate overall survival
measure: estimate survival rate at one year
measure: estimate duration of BOR
measure: evaluate proportion of patients whose duration of response is >=24 weeks
measure: estimate time to BOR
measure: evaluate safety profile of ipilimumab during the induction and maintenance phases
measure: evaluate health-related quality of life
measure: obtain PK sample for population PK analysis
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Chicago
country: United States
state: Illinois
city: Park Ridge
country: United States
state: Illinois
city: Goshen
country: United States
state: Indiana
city: Hazard
country: United States
state: Kentucky
city: Alburquerque
country: United States
state: New Mexico
city: New York
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Greenville
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Charlottesvillle
country: United States
state: Virginia
city: Salzburg
country: Austria
facility: Local Institution
city: Wels
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Turku
country: Finland
facility: Local Institution
city: Genova
country: Italy
facility: Local Institution
city: Meldola
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Torino
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: Barnaul
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Murmansk
country: Russian Federation
facility: Local Institution
city: Ryazan
country: Russian Federation
facility: Local Institution
city: Samara
country: Russian Federation
facility: Local Institution
city: St Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: Stavropol
country: Russian Federation
facility: Local Institution
city: Velikiy Novgorod
country: Russian Federation
facility: Local Institution
city: Voronezh
country: Russian Federation
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Tenerife
country: Spain
facility: Local Institution
city: Valencia
country: Spain
facility: Local Institution
city: Goteborg
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Uppsala
country: Sweden
facility: Local Institution
city: Cherkassy
country: Ukraine
facility: Local Institution
city: Dnipropetrovsk
country: Ukraine
facility: Local Institution
city: Kiev
country: Ukraine
facility: Local Institution
city: Lvov
country: Ukraine
facility: Local Institution
city: Sumy
country: Ukraine
facility: Local Institution
city: Uzhgorod
country: Ukraine
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
citation: Di Giacomo AM, Danielli R, Guidoboni M, Calabro L, Carlucci D, Miracco C, Volterrani L, Mazzei MA, Biagioli M, Altomonte M, Maio M. Therapeutic efficacy of ipilimumab, an anti-CTLA-4 monoclonal antibody, in patients with metastatic melanoma unresponsive to prior systemic treatments: clinical and immunological evidence from three patient cases. Cancer Immunol Immunother. 2009 Aug;58(8):1297-306. doi: 10.1007/s00262-008-0642-y. Epub 2009 Jan 13.