Study of CP-675,206 in Refractory Melanoma

NCT00254579 | Completed Phase 2

• 1 other identifier: A3671008
• Study Type: interventional
• Target: 251
• Locations: 9 countries
• Sites: 65

Brief Summary

CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.

Conditions

Refractory Melanoma

Keywords

refractory melanoma; malignant melanoma

Outcome Measures

Primary Outcomes (1)

• To assess the anti-tumor efficacy, as determined by objective response rate, of intravenous CP-675,206 administered at a dose of 15 mg/kg every 90 days to patients with relapsed or refractory advanced melanoma

  Tumor response is assessed every 2-3 months until disease progression

Secondary Outcomes (4)

• Safety

  At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug

• Pharmaco Kinetic

  At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug

• Survival

  At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug

• Health-related QoL

  At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug

Study Arms (1)

15 mg/kg CP-675,206

EXPERIMENTAL

Drug: CP-675,206

Interventions

CP-675,206 DRUG

15 mg/kg Q12W dosing regimen

15 mg/kg CP-675,206

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgically incurable Stage III or IV melanoma
• One prior systemic treatment for metastatic melanoma
• Measurable disease
• Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1

You may not qualify if:

• Melanoma of ocular origin
• Received prior vaccine
• Received prior CTLA4-inhibiting agent
• History of, or significant risk for, chronic inflammatory or autoimmune disease
• Potential requirement for systemic corticosteroids

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (65)

Research Site

Scottsdale, Arizona, 85260, United States

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Bentonville, Arkansas, 72712, United States

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Fayetteville, Arkansas, 72703, United States

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Little Rock, Arkansas, 72205, United States

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Los Angeles, California, 90095-6970, United States

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Los Angeles, California, 90095, United States

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Aurora, Colorado, 80045, United States

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Stamford, Connecticut, 06902-3628, United States

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Ocoee, Florida, 34761, United States

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Orlando, Florida, 32803, United States

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Orlando, Florida, 32804, United States

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Chicago, Illinois, 60637, United States

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Indianapolis, Indiana, 46202, United States

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Indianapolis, Indiana, 46237, United States

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Indianapolis, Indiana, 46260, United States

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Louisville, Kentucky, 40202, United States

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Baltimore, Maryland, 21237-3998, United States

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Boston, Massachusetts, 02215, United States

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Ann Arbor, Michigan, 48109-0946, United States

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Buffalo, New York, 14263, United States

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New York, New York, 10016, United States

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Chapel Hill, North Carolina, 27599-7600, United States

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Durham, North Carolina, 27710, United States

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Pfizer Investigational Site

Columbus, Ohio, 43210, United States

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Columbus, Ohio, 43210, United States

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Bethlehem, Pennsylvania, 18015, United States

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Pittsburgh, Pennsylvania, 15232, United States

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Nashville, Tennessee, 37232-6307, United States

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Nashville, Tennessee, 37232, United States

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Salt Lake City, Utah, 84112, United States

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Federal Way, Washington, 98003, United States

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Lakewood, Washington, 98499, United States

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Seattle, Washington, 98104, United States

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Seattle, Washington, 98122, United States

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Tacoma, Washington, 98405, United States

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Madison, Wisconsin, 53792, United States

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Ciudad de Buenos Aires, Buenos Aires, C1280AEA, Argentina

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Waratah, New South Wales, 2298, Australia

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Westmead, New South Wales, 2145, Australia

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Woolloongabba, Queensland, 4102, Australia

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East Melbourne, Victoria, 3002, Australia

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Nedlands, Western Australia, 6009, Australia

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Hamilton, Ontario, L8V 5C2, Canada

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Lille, Cedex, 59037, France

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Paris, 75651, France

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Villejuif, 94805, France

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Berlin, 10117, Germany

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Frankfurt, 60488, Germany

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Kiel, 24105, Germany

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Tübingen, 72076, Germany

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Meldola, FC, 47014, Italy

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Milan, 20132, Italy

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Milan, 20133, Italy

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Milan, 20141, Italy

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Barcelona, Barcelona, 08036, Spain

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Madrid, Madrid, 28046, Spain

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Pamplona, Navarre, 31008, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Truro, Cornwall, TR1 3LJ, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Sutton, Surrey, SM2 5PT, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, NE4 6BE, United Kingdom

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London, SW3 6JJ, United Kingdom

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Manchester, M20 4BX, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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MeSH Terms

Conditions

Melanoma

Interventions

tremelimumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 16, 2005
• Study Start: December 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 7, 2012

Record last verified: 2012-06

Locations

CA (1); DE (4); US (36); IT (4); AU (5); GB (7); AR (1); FR (3); ES (4)