Clinical trial NCT00257205: CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy
Official title: A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Melanoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-22
Enrollment: 655
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)


Eligibility criteria: Inclusion Criteria:

* Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
* Serum lactic acid dehydrogenase (LDH) \<= 2 x ULN
* ECOG performance status of 0 or 1

Exclusion Criteria:

* Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
* History of brain metastases

Primary outcomes:
measure: overall survival
timeFrame: August 2010
Secondary outcomes:
measure: adverse events
timeFrame: 1 year
measure: PFS at 6 months
timeFrame: 6 months
measure: objective tumor response
timeFrame: 1 year
measure: Durable response
timeFrame: 6 months
measure: pharmacokinetics endpoints
timeFrame: 15 months
measure: pharmacogenomic endpoints
timeFrame: 1 year
measure: HQol
timeFrame: 1 year
measure: healthcare resource utilization and loss of productivity
timeFrame: 1 year
measure: human antihuman antibody response for patients in Arm A
timeFrame: 15 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Mobile
country: United States
facility: Research Site
state: Alabama
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: Bakersfield
country: United States
facility: Research Site
state: California
city: Corona
country: United States
facility: Research Site
state: California
city: Fullerton
country: United States
facility: Research Site
state: California
city: Glendora
country: United States
facility: Research Site
state: California
city: Huntington Beach
country: United States
facility: Research Site
state: California
city: Long Beach
country: United States
facility: Research Site
state: California
city: Los Alamitos
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Oxnard
country: United States
facility: Research Site
state: California
city: Pasadena
country: United States
facility: Research Site
state: California
city: Pomona
country: United States
facility: Research Site
state: California
city: Rancho Cucamonga
country: United States
facility: Research Site
state: California
city: Santa Barbara
country: United States
facility: Research Site
state: California
city: Santa Maria
country: United States
facility: Research Site
state: California
city: West Covina
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Research Site
state: Florida
city: Lake Worth
country: United States
facility: Research Site
state: Florida
city: Zion
country: United States
facility: Research Site
state: Illinois
city: Beech Grove
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Creve Coeur
country: United States
facility: Research Site
state: Missouri
city: St Louis
country: United States
facility: Research Site
state: Missouri
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: St. Peters
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Henderson
country: United States
facility: Research Site
state: Nevada
city: Henderson
country: United States
facility: Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Morristown
country: United States
facility: Research Site
state: New Jersey
city: Albany
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Research Site
state: North Carolina
city: Canton
country: United States
facility: Research Site
state: Ohio
city: Columbus
country: United States
facility: Research Site
state: Ohio
city: Dover
country: United States
facility: Research Site
state: Ohio
city: Bethlehem
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Federal Way
country: United States
facility: Research Site
state: Washington
city: Lakewood
country: United States
facility: Research Site
state: Washington
city: Tacoma
country: United States
facility: Research Site
state: Washington
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Waratah
country: Australia
facility: Research Site
state: New South Wales
city: Westmead
country: Australia
facility: Research Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Research Site
state: Queensland
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Launceston
country: Australia
facility: Research Site
state: Tasmania
city: East Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Wien
country: Austria
facility: Research Site
city: Brussel
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Calgary
country: Canada
facility: Research Site
state: Alberta
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Vancouver
country: Canada
facility: Research Site
state: British Columbia
city: Victoria
country: Canada
facility: Research Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Research Site
state: Manitoba
city: Hamilton
country: Canada
facility: Research Site
state: Ontario
city: London
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Windsor
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Quebec
country: Canada
facility: Research Site
city: Montpellier
country: France
facility: Research Site
state: Cedex 05
city: Besancon
country: France
facility: Research Site
city: Bordeaux
country: France
facility: Research Site
city: Boulogne
country: France
facility: Research Site
city: Caen
country: France
facility: Research Site
city: Lille
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Nantes Cedex 1
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Frankfurt
country: Germany
facility: Research Site
city: Hannover
country: Germany
facility: Research Site
city: Kiel
country: Germany
facility: Research Site
city: Tuebingen
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Jerusalem
country: Israel
facility: Research Site
city: Tel Aviv
country: Israel
facility: Research Site
city: Tel Hashomer
country: Israel
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Padova
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Siena
country: Italy
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
state: DF
city: Mexico
country: Mexico
facility: Research Site
state: DF
city: Groningen
country: Netherlands
facility: Research Site
state: GR
city: Amsterdam
country: Netherlands
facility: Research Site
state: NH
city: Leiden
country: Netherlands
facility: Research Site
state: ZH
city: Nijmegen
country: Netherlands
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lubin
country: Poland
facility: Research Site
city: Poznan
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Obninsk
country: Russian Federation
facility: Research Site
state: Kaluga Region
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Oviedo
country: Spain
facility: Research Site
state: Asturias
city: Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Barcelona
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Palma de Mallorca
country: Spain
facility: Research Site
state: Islas Baleares
city: Pamplona
country: Spain
facility: Research Site
state: Navarra
city: Barcelona
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Truro
country: United Kingdom
facility: Research Site
state: Cornwall
city: Northwood
country: United Kingdom
facility: Research Site
state: Middlesex
city: Sutton
country: United Kingdom
facility: Research Site
state: Surrey
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Research Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Research Site
city: Wolverhampton
country: United Kingdom
facility: Research Site
Study officials:
References:
citation: Friedlander P, Wood K, Wassmann K, Christenfeld AM, Bhardwaj N, Oh WK. A whole-blood RNA transcript-based gene signature is associated with the development of CTLA-4 blockade-related diarrhea in patients with advanced melanoma treated with the checkpoint inhibitor tremelimumab. J Immunother Cancer. 2018 Sep 18;6(1):90. doi: 10.1186/s40425-018-0408-9.
citation: Ribas A, Kefford R, Marshall MA, Punt CJ, Haanen JB, Marmol M, Garbe C, Gogas H, Schachter J, Linette G, Lorigan P, Kendra KL, Maio M, Trefzer U, Smylie M, McArthur GA, Dreno B, Nathan PD, Mackiewicz J, Kirkwood JM, Gomez-Navarro J, Huang B, Pavlov D, Hauschild A. Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol. 2013 Feb 10;31(5):616-22. doi: 10.1200/JCO.2012.44.6112. Epub 2013 Jan 7.