CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy
June 25, 2012 updated by: AstraZeneca
A Phase 3, Open Label, Randomized, Comparative Study Of CP-675,206 And Either Dacarbazine Or Temozolomide In Patients With Advanced Melanoma
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)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
655
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Buenos Aires
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Ciudad de Buenos Aires, Buenos Aires, Argentina, C1280AEA
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New South Wales
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Waratah, New South Wales, Australia, 2300
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Westmead, New South Wales, Australia, 2145
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Queensland
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Woolloongabba, Queensland, Australia, 4102
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South Australia
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Adelaide, South Australia, Australia, 5000
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Tasmania
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Launceston, Tasmania, Australia, 7250
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Victoria
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East Melbourne, Victoria, Australia, 3002
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Wien, Austria, A-1090
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Brussel, Belgium, 1090
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Leuven, Belgium, 3000
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Namur, Belgium, 5000
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Roeselare, Belgium, 8800
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Turnhout, Belgium, 2300
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Wilrijk, Belgium, 2610
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Yvoir, Belgium, 5530
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Quebec, Canada, G1R 2J6
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Alberta
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Calgary, Alberta, Canada, T2N 4N2
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Edmonton, Alberta, Canada, T6G 1Z2
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
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Victoria, British Columbia, Canada, V8R 6V5
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
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London, Ontario, Canada, N6A 4L6
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Toronto, Ontario, Canada, M5G 2M9
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Toronto, Ontario, Canada, M4N 3M5
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Windsor, Ontario, Canada, N8W 1L9
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Windsor, Ontario, Canada, N8W 2X3
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Quebec
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Montreal, Quebec, Canada, H2L 4M1
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Besancon, France, 25030
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Bordeaux, France, 33075
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Boulogne, France, 92104
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Caen, France, 14033
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Lille, France, 59000
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Marseille, France, 13009
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Nantes Cedex 1, France, 44035
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Paris, France, 75010
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Cedex 05
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Montpellier, Cedex 05, France, 34280
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Berlin, Germany, 10117
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Frankfurt, Germany, 60488
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Hannover, Germany, 30449
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Kiel, Germany, 24105
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Tuebingen, Germany, 72076
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Athens, Greece, 115 27
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Jerusalem, Israel, 91120
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Tel Aviv, Israel, 64239
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Tel Hashomer, Israel, 52621
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Genova, Italy, 16132
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Milano, Italy, 20141
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Napoli, Italy, 80131
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Padova, Italy, 35128
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Roma, Italy, 00144
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Siena, Italy, 53100
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DF
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Mexico, DF, Mexico, 06720
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Mexico, DF, Mexico, 14080
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Nijmegen, Netherlands, 6525 GA
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GR
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Groningen, GR, Netherlands, 9713 GZ
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NH
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Amsterdam, NH, Netherlands, 1066 CX
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ZH
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Leiden, ZH, Netherlands, 2311 JS
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Bialystok, Poland, 15-027
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Krakow, Poland, 31-115
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Lubin, Poland, 59-300
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Poznan, Poland, 61-866
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Warszawa, Poland, 02-781
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Moscow, Russian Federation, 115478
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St. Petersburg, Russian Federation, 197758
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Kaluga Region
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Obninsk, Kaluga Region, Russian Federation, 249036
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Bratislava, Slovakia, 833 10
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Cape Town, South Africa, 7500
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Pretoria, South Africa, 0181
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Barcelona, Spain, 08036
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Madrid, Spain, 28041
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Zaragoza, Spain, 50009
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Asturias
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Oviedo, Asturias, Spain, 33006
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Barcelona
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Hospitalet de Llobregat, Barcelona, Spain, 08907
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Cantabria
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Santander, Cantabria, Spain, 39008
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Islas Baleares
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Palma de Mallorca, Islas Baleares, Spain, 07014
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Navarra
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Pamplona, Navarra, Spain, 31008
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Goteborg, Sweden, 413 45
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Lund, Sweden, 221 85
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Zurich, Switzerland, 8091
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London, United Kingdom, SW3 6JJ
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Manchester, United Kingdom, M20 4BX
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Newcastle Upon Tyne, United Kingdom, NE7 7DN
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Newcastle upon Tyne, United Kingdom, NE4 6BE
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Wolverhampton, United Kingdom, WV10 0QP
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Cornwall
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Truro, Cornwall, United Kingdom, TR1 3LJ
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Middlesex
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Northwood, Middlesex, United Kingdom, HA6 2RN
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
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Alabama
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Huntsville, Alabama, United States, 35805
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Mobile, Alabama, United States, 36607
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Arizona
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Scottsdale, Arizona, United States, 85260
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Arkansas
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Little Rock, Arkansas, United States, 72205
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California
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Bakersfield, California, United States, 93309
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Corona, California, United States, 92879
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Fullerton, California, United States, 92835
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Glendora, California, United States, 91741
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Huntington Beach, California, United States, 92648
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Long Beach, California, United States, 90813
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Los Alamitos, California, United States, 90720
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Los Angeles, California, United States, 90095-6970
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Los Angeles, California, United States, 90095
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Oxnard, California, United States, 93030
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Pasadena, California, United States, 91105
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Pomona, California, United States, 91767
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Rancho Cucamonga, California, United States, 91730
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Santa Barbara, California, United States, 93105
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Santa Maria, California, United States, 93454
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West Covina, California, United States, 91790
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Colorado
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Aurora, Colorado, United States, 80045
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Connecticut
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Stamford, Connecticut, United States, 06902-3628
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Florida
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Boynton Beach, Florida, United States, 33426
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Lake Worth, Florida, United States, 33461-4710
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Illinois
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Zion, Illinois, United States, 60099
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Indiana
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Beech Grove, Indiana, United States, 46107
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Indianapolis, Indiana, United States, 46237
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Indianapolis, Indiana, United States, 46260
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Maryland
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Baltimore, Maryland, United States, 21237-3998
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Missouri
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Creve Coeur, Missouri, United States, 63141
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St Louis, Missouri, United States, 63110
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St. Louis, Missouri, United States, 63110
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St. Peters, Missouri, United States, 63376
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Nebraska
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Omaha, Nebraska, United States, 68114
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Nevada
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Henderson, Nevada, United States, 89052
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Henderson, Nevada, United States, 89015
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Las Vegas, Nevada, United States, 89109
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Las Vegas, Nevada, United States, 89148
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Las Vegas, Nevada, United States, 89128
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Las Vegas, Nevada, United States, 89135
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New Jersey
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Morristown, New Jersey, United States, 07962
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New York
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Albany, New York, United States, 12206
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New York, New York, United States, 10016
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North Carolina
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Chapel Hill, North Carolina, United States, 27599-7600
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Charlotte, North Carolina, United States, 28204
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Charlotte, North Carolina, United States, 28203
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Ohio
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Canton, Ohio, United States, 44718
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Columbus, Ohio, United States, 43210
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Dover, Ohio, United States, 44718
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
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Pittsburgh, Pennsylvania, United States, 15232
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Texas
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Dallas, Texas, United States, 75246
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Utah
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Salt Lake City, Utah, United States, 84112
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Washington
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Federal Way, Washington, United States, 98003
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Lakewood, Washington, United States, 98499
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Tacoma, Washington, United States, 98405
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A
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CP-675,206 15 mg/kg IV Q 90 days x 4
Other Names:
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Active Comparator: B
Choice of one or the other Dacarbazine or Temozolomide(CP-675,206) (choice)
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decarbazine 1000 mg/m2 IV Q 21 days x 12
temozolomide 200 mg/m2 orally on Days 1-5 every 28 days x 12
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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overall survival
Time Frame: August 2010
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August 2010
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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adverse events
Time Frame: 1 year
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1 year
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PFS at 6 months
Time Frame: 6 months
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6 months
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objective tumor response
Time Frame: 1 year
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1 year
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Durable response
Time Frame: 6 months
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6 months
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pharmacokinetics endpoints
Time Frame: 15 months
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15 months
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pharmacogenomic endpoints
Time Frame: 1 year
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1 year
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HQol
Time Frame: 1 year
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1 year
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healthcare resource utilization and loss of productivity
Time Frame: 1 year
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1 year
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human antihuman antibody response for patients in Arm A
Time Frame: 15 months
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15 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
November 18, 2005
First Submitted That Met QC Criteria
November 18, 2005
First Posted (Estimate)
November 22, 2005
Study Record Updates
Last Update Posted (Estimate)
July 2, 2012
Last Update Submitted That Met QC Criteria
June 25, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Temozolomide
- Tremelimumab
- Dacarbazine
Other Study ID Numbers
- A3671009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.