Study of Entinostat With Nivolumab Plus Ipilimumab in Previously Treated Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03552380|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Entinostat Drug: Nivolumab Drug: Ipilimumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study to Evaluate the Safety, Pharmacodynamics, and Efficacy of Entinostat in Combination With Nivolumab Plus Ipilimumab in Patients With Renal Cell Carcinoma Previously Treated With Nivolumab Plus Ipilimumab|
|Actual Study Start Date :||August 31, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||August 2021|
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
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 14 day cycles.
Nivolumab will continue until disease progression or prohibitive toxicity. Cycles 1-4 are 21 day cycles. Cycles 5 and subsequent are 14 day cycles.
Other Name: Opdivo
Ipilimumab will be administered in combination with entinostat and nivolumab for Cycles 1-4 only.
Other Name: Yervoy
- Establish the recommended Phase II dose (RP2D) [ Time Frame: 6 months ]The Safety Lead-In will be Entinostat tested in 6-subject cohorts with a dose de-escalation design (5 mg, 3 mg and 2 mg) in combination with fixed dose nivolumab and ipilimumab.
- Objective Response Rate (ORR) via RECIST 1.1 [ Time Frame: 24 months ]Assess ORR via RECIST 1.1 during the Phase II study of entinostat in combination with nivolumab and ipilimumab in subjects with metastatic RCC who have progressed on nivolumab + ipilimumab regimen. ORR is defined as the rate of complete response (CR) + partial response (PR).
- Assess Adverse Events [ Time Frame: 24 months ]Assess adverse events according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4
- ORR via irRC [ Time Frame: 24 months ]Assess ORR via immune related response criteria (irRC) during the Phase II study of entinostat in combination with nivolumab and ipilimumab in subjects with metastatic RCC who have progressed on nivolumab + ipilimumab regimen. ORR is defined as the rate of complete response (irCR) + partial response (irPR).
- Progression Free Survival (PFS) via RECIST 1.1 [ Time Frame: 24 months ]PFS per RECIST 1.1 is defined from day 1 of treatment until disease progression or death as a result of any cause, with progression defined per RECIST 1.1
- Progression Free Survival (PFS) via irRC [ Time Frame: 24 months ]PFS per irRC is defined from day 1 of treatment until disease progression or death as a result of any cause, with progression defined per irRC.
- Overall Survival (OS) [ Time Frame: 24 ]OS is defined from Day 1 of treatment until death as a result of any cause
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552380
|Contact: Roberto Pili, MDfirstname.lastname@example.org|
|Contact: Lisa Benson||317-634-5842 ext email@example.com|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20057|
|Contact: Gayle Cramer 202-687-1116 firstname.lastname@example.org|
|Principal Investigator: Michael Atkins, MD|
|United States, Indiana|
|Indiana Univeristy Melvin and Bren Simon Cancer Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Roberto Pili, MD 317-278-7776 email@example.com|
|Principal Investigator: Roberto Pili, MD|
|Principal Investigator:||Roberto Pili, MD||Indiana Univervisty Simon Cancer Center|