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NCT Number: NCT00378482

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.

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

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Key information

Conditions

Colorectal Neoplasms Adenocarcinoma Carcinoma Carcinoma, Renal Cell Colonic Diseases Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Patients Who Have/Have Had Melanoma and Other Tumors Prostatic Diseases Prostatic Neoplasms Rectal Diseases Renal Cell Carcinoma Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Newecastle Upon Tyne, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CP-675,206 (Tremelimumab)

Drug

15 mg/kg IV every 3 months as long as required

Other names: anti-CTLA4 human monoclonal antibody

Primary outcomes

  1. Safety Endpoints: Serious Adverse Events to Tremelimumab.

    Time frame: 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.

  2. Safety Endpoints: Grade 3 or 4 Tremelimumab-related Adverse Events to Tremelimumab.

    Time frame: 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.

  3. Safety Endpoints: Hypersensitivity Reactions to Tremelimumab.

    Time frame: 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.

  4. Efficacy Endpoints: Tumor Status: Alive With Disease (AWD) or no Evidence of Disease (NED)

    Time frame: 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.

  5. Efficacy Endpoints: Survival

    Time frame: 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 outcomes

  1. Disease Free Survival

    Time frame: 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.

    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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2023
Study completion
2023
First posted
Sep 20, 2006
Registry last updated
Aug 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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