A ROLLOVER PROTOCOL FOR PATIENTS WHO RECEIVED CP-675,206 IN OTHER PROTOCOLS - ND
- Conditions
- Patients who have/have had Melanoma and Other TumorsMedDRA version: 9.1Level: LLTClassification code 10007284Term: Carcinoma
- Registration Number
- EUCTR2008-000989-23-IT
- Lead Sponsor
- PFIZER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. The subject received CP-675,206 in another protocol. 2. Females of childbearing potential must agree to practice a form of effective contraception for 12 months following any dose of study drug. The definition of effective contraception will be based on the judgment of the investigator. 3. Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
There are no exclusion criteria. Note that subjects must meet all of the redosing criteria (Sections 5.2.3.2 and 5.2.3.3) in order to receive any dose of CP-675,206 in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: . To allow access to CP-675,206 for subjects who received CP-675,206 in other trials;Secondary Objective: . To follow long-term survival and tumor status of subjects treated with CP-675,206 in other trials To monitor the safety and tolerability of CP-675,206;Primary end point(s): Safety Endpoints Serious adverse events Grade 3 or 4 CP-675,206-related adverse events Immune-mediated adverse events Hypersensitivity reactions to CP-675,206 Efficacy Endpoints Tumor status: alive with disease (AWD) or no evidence of disease (NED) Survival
- Secondary Outcome Measures
Name Time Method