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OpenTrials
Completed

NCT Number: NCT00254579

Study of CP-675,206 in Refractory Melanoma

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Ciudad de Buenos Aires, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

CP-675,206

Drug

15 mg/kg Q12W dosing regimen

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

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

Secondary outcomes

  1. Safety

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

  2. Pharmaco Kinetic

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

  3. Survival

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

  4. Health-related QoL

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase 2, Open Label, Single Arm Study To Evaluate The Efficacy, Safety, Tolerability And Pharmacokinetics Of CP-675,206 In Patients With Advanced Refractory And/Or Relapsed Melanoma

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 16, 2005
Registry last updated
Jun 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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