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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014