Combination of Pembrolizumab With TGR-1202 in Patients With Relapsed/Refractory CLL and B-cell NHL
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
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.