Melanoma Clinical Trial
Official title:
A Rollover Protocol For Patients Who Received Tremelimumab (CP-675,206 ) In Other Protocols
Verified date | November 2023 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.
Status | Completed |
Enrollment | 37 |
Est. completion date | October 27, 2023 |
Est. primary completion date | October 27, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 130 Years |
Eligibility | Inclusion Criteria: - The subject must have already received tremelimumab in another protocol - 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 judgement of the investigator. - Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Research Site | Newecastle Upon Tyne | |
United States | Research Site | Ann Arbor | Michigan |
United States | Research Site | Houston | Texas |
United States | Research Site | Los Angeles | California |
United States | Research Site | New York | New York |
United States | Research Site | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Endpoints: Serious Adverse Events to Tremelimumab. | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. | ||
Primary | Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab. | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. | ||
Primary | Safety Endpoints: Hypersensitivity Reactions to Tremelimumab. | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. | ||
Primary | Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED) | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. | ||
Primary | Efficacy Endpoints: Survival | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. | ||
Secondary | Disease Free Survival | Time from the first dose of study drug to the earliest date of evidence of disease (based on tumor status assessment) or death, whichever occurred first | Following the first dose, until at least 90 days since the previous dose of tremelimumab or at least 28 days since any study-related procedures. Actual median study duration was 2.2 years. |
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