Study of CP-675,206 in Refractory Melanoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00254579
First received: November 14, 2005
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Refractory Melanoma
Drug: CP-675,206
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug ] [ Designated as safety issue: No ]
  • Pharmaco Kinetic [ Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug ] [ Designated as safety issue: No ]
  • Health-related QoL [ Time Frame: At every scheduled visit as specified per protocol for a maximum of 2 years from first dose of drug ] [ Designated as safety issue: No ]

Enrollment: 251
Study Start Date: December 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 15 mg/kg CP-675,206 Drug: CP-675,206
15 mg/kg Q12W dosing regimen

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254579

  Show 65 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00254579     History of Changes
Other Study ID Numbers: A3671008
Study First Received: November 14, 2005
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
refractory melanoma
malignant melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 16, 2014