A Rollover Study for Patients Who Received Tremelimumab in Other Protocols, to Allow the Patients Access to Tremelimumab Until This Agent Becomes Commercially Available or Development is Discontinued.

Melanoma Clinical Trial

Official title:

A Rollover Protocol For Patients Who Received Tremelimumab (CP-675,206 ) In Other Protocols

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378482
• Other study ID #: D4881C00024
• Secondary ID: D4881C00024 (A36
• Status: Completed
• Phase: Phase 2
• Start date: March 5, 2007
• Est. completion date: October 27, 2023

Study information

• Verified date: November 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is intended to provide access to tremelimumab for patients who have previously received tremelimumab in a clinical trial.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Colorectal Neoplasms
• Melanoma
• Neoplasms
• Patients Who Have/Have Had Melanoma and Other Tumors
• Prostatic Neoplasms
• Renal Cell Carcinoma

Intervention

Drug:
• CP-675,206 (Tremelimumab)
15 mg/kg IV every 3 months as long as required

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

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.

External Links

•   Redacted CSP
•   Redacted SAP