Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Roberto Pili
Study ID
NCT03552380
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Entinostat — DRUG
    RP2D will be determined with a 6 patient safety lead-in. Entinostat will continue until disease progression or prohibitive toxicity. Cycles 1-4 are 21 day cycles. Cycles 5 and subsequent are 28 day cycles.
  • Nivolumab — DRUG
    Nivolumab will continue until disease progression or prohibitive toxicity. Cycles 1-4 are 21 day cycles. Cycles 5 and subsequent are 28 day cycles.
  • Ipilimumab — DRUG
    Ipilimumab will be administered in combination with entinostat and nivolumab for Cycles 1-4 only.

Study Details

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 4 weeks or every 2 weeks based on subject tolerance (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.

Key Dates

Start date
Jul 31, 2018
Status verified
Aug 2024
Primary completion
Jun 7, 2022
Completion
Feb 15, 2024

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Entinostat, Nivolumab and Ipilimumab
    Entinostat: 5mg, 3mg, or 2mg orally (PO) on D1, 8, 15 plus Nivolumab: 3 mg/kg IV D1 and Ipilimumab 1 mg/kg IV D1 Each cycle is 21 days

Primary Outcome Measure

Objective Response Rate (ORR) Via RECIST 1.1 [ Time Frame: From C1D1 until death or up to 31 months. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Georgetown UniversityWashington D.C.District of Columbia20057-
Indiana Univeristy Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-

Find similar trials in Washington D.C., DC

By condition
Kidney cancer
By specialty
OncologyUrology
By research site
Georgetown University· Washington D.C., DCIndiana Univeristy Melvin and Bren Simon Cancer Center· Indianapolis, IN

Related Studies