The following studies have recently been activated for patient enrollment by the University of Illinois Cancer Center Clinical Trials Office (CTO). Please click on the link to learn about the details regarding the study on ClinicalTrials.gov. For more information or questions about a study, please email [email protected] or call 312-355-5112.
A Phase I/II Study of Nivolumab, Ipilimumab and Plinabulin in Patients with Recurrent Small Cell Lung Cancer: Big Ten Cancer Research Consortium BTCRC-LUN17-127
An open-label Phase I/II study, with a dose escalation part (Phase I) and a two-arm randomized part (Phase II), in patients with recurrent SCLC (small cell lung cancer).
During Phase I, patients will receive plinabulin at escalating doses in combination with nivolumab and ipilimumab. Doses of the study drug will be administered as intravenous (IV) infusions in 21-day cycles. Patients will receive all study drugs on Day 1 of each cycle. After four treatment cycles, ipilimumab is stopped and patients continue treatment with nivolumab and plinabulin every two weeks (maintenance period) or until disease progression, development of unacceptable toxicity or one of the protocol-defined reasons for treatment discontinuation occurs.
At least three patients will be enrolled in each cohort, starting at 20 mg/m2 of plinabulin. The dose of plinabulin will be escalated in sequential patient cohorts after the safety data from the first cycle is reviewed. Thereafter the dose of plinabulin will be escalated to 30 mg/m2, provided that dose-limiting toxicities (DLTs) are not observed per the specified criteria, until the RP2D is determined.
In Phase II, about 40 patients will be randomized in a 1:1 ratio to receive either nivolumab plus ipilimumab (Arm NI) or the triple combination of plinabulin (at RP2D) plus nivolumab plus ipilimumab (Arm PNI). Patients will continue treatment until disease progression, development of unacceptable toxicity or one of the protocol-defined reasons for treatment discontinuation occurs.
Principle Investigator: Lawrence Feldman, MD