Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00378482
Other study ID # D4881C00024
Secondary ID D4881C00024 (A36
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Completed NCT03979872 - Risk Information and Skin-cancer Education for Undergraduate Prevention N/A
Recruiting NCT04986748 - Using QPOP to Predict Treatment for Sarcomas and Melanomas
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Active, not recruiting NCT05470283 - Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma Phase 1
Recruiting NCT05077137 - A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy Phase 1
Active, not recruiting NCT02721459 - XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma Phase 1
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Recruiting NCT05839912 - Excision of Lymph Node Trial (EXCILYNT) (Mel69) N/A
Recruiting NCT04971499 - A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma Phase 1/Phase 2
Recruiting NCT05263453 - HL-085+Vemurafenib to Treat Advanced Melanoma Patients With BRAF V600E/K Mutation Phase 2
Active, not recruiting NCT05060432 - Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06413680 - A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies Phase 1/Phase 2
Terminated NCT03399448 - NY-ESO-1-redirected CRISPR (TCRendo and PD1) Edited T Cells (NYCE T Cells) Phase 1
Completed NCT03348891 - TNF in Melanoma Patients Treated With Immunotherapy N/A
Completed NCT03171064 - Exercise as a Supportive Measure for Patients Undergoing Checkpoint-inhibitor Treatment Phase 2
Not yet recruiting NCT05539118 - Interferon-α1b Combined With Toripalimab and Anlotinib Hydrochloride in Advanced Unresectable Melanoma Phase 1/Phase 2
Recruiting NCT05171374 - pRospective Evaluation of Clinical Outcomes in Patients With metAsTatIс melanOma Treated With dabrafeNib and trAmetinib in reaL practicE
Withdrawn NCT02854488 - Yervoy Pregnancy Surveillance Study

External Links