Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma
Status:
Active, not recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
Summary
This is a Phase II, open-label, safety, pharmacodynamic and efficacy study of entinostat in
combination with nivolumab and ipilimumab in subjects with metastatic renal cell carcinoma
(RCC) who have progressed on ipilimumab + nivolumab regimen. Prior to Phase II, a safety
lead-in will be conducted to establish the RP2D of entinostat when used in combination with
ipilimumab + nivolumab. Subjects will initially be treated with the combination of oral
entinostat and intravenous (IV) nivolumab plus ipilimumab. Entinostat will be dosed weekly,
and nivolumab and ipilimumab will be dosed every 3 weeks, for a total of four, 3-week cycles.
Following these first four cycles, entinostat will continue to be administered weekly in
combination with nivolumab every 2 weeks (ipilimumab will be discontinued), with treatment
continued until disease progression or prohibitive toxicity. Anti-tumor activity will be
assessed by radiological tumor assessments conducted at baseline and every 6 weeks thereafter
using RECIST version 1.1.
Phase:
Phase 2
Details
Lead Sponsor:
Roberto Pili
Collaborators:
Bristol-Myers Squibb Indiana University School of Medicine Syndax Pharmaceuticals