A ROLLOVER PROTOCOL FOR PATIENTS WHO RECEIVED TREMELIMUMAB (CP-675,206) IN OTHER PROTOCOLS

Phase 1

• Conditions: Patients who have / have had Melanoma and Other Tumors; MedDRA version: 20.0Level: LLTClassification code 10007284Term: CarcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-000989-23-GB
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-17
• Study Completion: 2023-10-27
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

1. The subject received Tremelimumab in another protocol.
2. 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 judgment of the investigator.
3. Subject must be willing and able to provide written informed consent and to comply with scheduled visits and other trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

None

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To allow access to tremelimumab for subjects who received tremelimumab in other trials;Secondary Objective: To follow long-term survival and tumor status of subjects treated with tremelimumab in<br>other trials<br><br>To monitor the safety and tolerability of tremelimumab;Primary end point(s): Safety Endpoints:<br>• Serious adverse events<br>• Grade 3 or 4 tremelimumab-related adverse events<br>• Immune-mediated adverse events<br>• Hypersensitivity reactions to CP-675,206<br><br>Efficacy Endpoints:<br>• Tumor status: alive with disease (AWD) or no evidence of disease (NED)<br>• Survival;Timepoint(s) of evaluation of this end point: Ongoing through out trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): n/a;Timepoint(s) of evaluation of this end point: n/a