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.

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

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

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

Intervention / Treatment
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* Drug: CP-675,206 (Tremelimumab)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 130 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug: CP-675,206 (Tremelimumab) | Drug: CP-675,206 (Tremelimumab)<br>* 15 mg/kg IV every 3 months as long as required<br>* Other names: anti-CTLA4 human monoclonal antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melanoma and other tumors