Clinical Trial: Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
Brief Summary: This is a Phase 2, multi-center, open-label study in patients with surgically incurable stage III or IV uveal melanoma who have not received prior immunotherapy. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 has been shown to induce durable tumor responses in patients with metastatic melanoma in phase 1 and phase 2 clinical studies.
Detailed Summary:
Sponsor: Alberta Health Services
Current Primary Outcome: Progression-free survival at 6 months after initiation of CP-675,206 [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Objective tumor response [ Time Frame: overall ]
- Durable response, defined as an objective tumor response that last 6 or more months [ Time Frame: 6 or more months ]
- Median survival and overall survival [ Time Frame: overall ]
- Adverse events and tolerability [ Time Frame: overall ]
Original Secondary Outcome: Same as current
Information By: AHS Cancer Control Alberta
Dates:
Date Received: December 15, 2009
Date Started: January 2010
Date Completion:
Last Updated: January 18, 2012
Last Verified: September 2011
