NCT01103635

Tremelimumab and CP-870,893 in Patients With Metastatic Melanoma

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-870,893 (Agonist Anti-CD40 Antibody) In Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as tremelimumab and CD40 agonist monoclonal antibody CP-870,893, 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-870,893 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- 870,893 (administered intravenously every 3 weeks). SECONDARY OBJECTIVES: I To seek preliminary evidence of anti-tumor efficacy of the combination of tremelimumab and CP-870,893, including objective response rate at MTD. II. To determine the immune pharmacodynamic changes associated with the administration of the combination of tremelimumab and CP-870,893. OUTLINE: Patients receive tremelimumab IV over 1 hour on day 1 and CD40 agonist monoclonal antibody CP-870,893 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.

Conditions

• Recurrent Melanoma
• Stage IV Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	CD40 agonist monoclonal antibody CP-870,893	Given IV
BIOLOGICAL	tremelimumab	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2010-02-01
• Primary completion: 2016-05-01
• Completion: 2016-05-02
• First posted: 2010-04-14
• Last updated: 2020-04-07

Locations

1 site across 1 country: United States