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Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589)
Protocol Number:
Phase I
Patrick Forde
Johns Hopkins Kimmel Cancer Center in Baltimore
During the dose escalation part of the study, patients will be treated with a fixed dose ofPDR001, administered i.v., in combination with one of the following combination partners, to determine safety, tolerability and maximum tolerated dose with LCL161, Everolimus or Panobinostat (LBH589).During expansion, the main objective is to further assess the safety and tolerability of any study treatment at the maximum tolerated dose.
- 18 years or older- Measurable disease that has progressed despite standard therapy.- Good performance status. Can care for self and is ambulatory.- Must be able to undergo 2 biopsies.
PDR001 by IV infusion every 28 days. This will be given with one of the oral medications.LCL161 by mouth on days 1, 8, 15, and 22 of a 28 day cycle.Everolimus by mouth on days 1, 8, 15, and 22 of a 28 day cycle.Panobinostat by mouth 3 days a week. This is given two weeks on and one week off.
Last Update
08/08/2020 05:02 AM