Ignite Creation Date:
2024-05-05 @ 10:25 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01103635
Status:
COMPLETED
Last Update Posted:
2020-04-07
First Post:
2010-04-12
Brief Title:
Tremelimumab and CP-870893 in Patients With Metastatic Melanoma
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
A Phase 1 Dose-Escalation Trial To Evaluate Safety Tolerability And Immune Pharmacodynamics Of Combined Administration Of Tremelimumab Blocking Anti-CTLA-4 Antibody And CP-870893 Agonist Anti-CD40 Antibody In Patients With Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as tremelimumab and CD40 agonist monoclonal antibody CP-870893 can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry cancer-killing substances to them Giving tremelimumab together with CD 40 agonist monoclonal antibody CP-870 893 may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of giving tremelimumab together with CD40 agonist monoclonal antibody CP-870893 in treating patients with metastatic melanoma
PURPOSE This phase I trial is studying the side effects and best dose of giving tremelimumab together with CD40 agonist monoclonal antibody CP-870893 in treating patients with metastatic melanoma
Detailed Description:
PRIMARY OBJECTIVES
I To assess the safety dose-limiting toxicities and maximum tolerated doses of tremelimumab administered intravenously every 12 weeks and CP- 870893 administered intravenously every 3 weeks
SECONDARY OBJECTIVES
I To seek preliminary evidence of anti-tumor efficacy of the combination of tremelimumab and CP-870893 including objective response rate at MTD
II To determine the immune pharmacodynamic changes associated with the administration of the combination of tremelimumab and CP-870893
OUTLINE Patients receive tremelimumab IV over 1 hour on day 1 and CD40 agonist monoclonal antibody CP-870893 IV over 30 minutes on days 2 22 43 and 64 Treatment repeats every 12 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks
I To assess the safety dose-limiting toxicities and maximum tolerated doses of tremelimumab administered intravenously every 12 weeks and CP- 870893 administered intravenously every 3 weeks
SECONDARY OBJECTIVES
I To seek preliminary evidence of anti-tumor efficacy of the combination of tremelimumab and CP-870893 including objective response rate at MTD
II To determine the immune pharmacodynamic changes associated with the administration of the combination of tremelimumab and CP-870893
OUTLINE Patients receive tremelimumab IV over 1 hour on day 1 and CD40 agonist monoclonal antibody CP-870893 IV over 30 minutes on days 2 22 43 and 64 Treatment repeats every 12 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-00507 | None | None | None |