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
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).
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.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity as assessed by CTCAE v3.0
Toxicities which occur during later cycles will be monitored and described separately. The MTD is defined as the dose level at which 0-1/6 patients experience DLT in the first 12 week cycle and at least 2/3 or 2/6 patients treated at the next higher dose level (unless MTD is level 4) experience DLT in the first 12 week cycle.
Robert Vonderheide, MD, DPhil
Abramson Cancer Center of the University of Pennsylvania
United States: Institutional Review Board
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|