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Brief Title Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHL
Official Title A Phase I, Open-label, Dose-escalation Study to Assess the Safety, Tolerability and Efficacy of the Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-Cell Non-Hodgkin Lymphoma (NHL)
Principal Investigator Thirman, Michael
Brief Summary This study will be a standard 3+3 design with a lead in of TGR-1202 at dose of 600mg (dose level 1) or 800mg daily (dose level 2) for 6 weeks, i.e. 2 cycles, followed by pembrolizumab at 200mg every 3 weeks for 8 cycles along with TGR-1202 for patients with relapsed/refractory B-cell NHL or CLL. If the dose of 600mg daily of TGR-1202 (dose level 1) is tolerated in the first cohort the dose will be increased to 800mg qd which is the only and final dose escalation. If TGR-1202 is not tolerated at 600mg daily the dose will be decreased to 400mg daily. The lead in of TGR-1202 was chosen to ensure clinical benefit and to minimize the occurrence of early overlapping toxicity with pembrolizumab as most toxicities were observed early on in the treatment with idelalisib, a related PI3K-inhibitor, and rituximab.
Gender All
Ages 18 Years
Enrollment 36
Accepts Healthy Volunteers No
Lead Sponsor University of ChicagoOther
Collaborator
Study Design
Study Phase Phase 1
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition CLL
Detail for Health Professional (on clinicaltrials.gov)
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