Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03781960|
Recruitment Status : Completed
First Posted : December 20, 2018
Last Update Posted : June 16, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Abemaciclib Drug: Nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma|
|Actual Study Start Date :||July 31, 2019|
|Actual Primary Completion Date :||April 29, 2022|
|Actual Study Completion Date :||April 29, 2022|
Experimental: Abemaciclib & Nivolumab
Subjects will receive abemaciclib monotherapy 150mg twice daily for seven days then will initiate nivolumab 480mg IV every 28 days while continuing twice daily abemaciclib.
Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
Other Name: Verzenio
Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
Other Name: Opdivo
- Overall response rate by investigator review [ Time Frame: Assessed at the completion of all subjects' participation on the study, estimated to be approximately 36 months ]Overall response rate by investigator review using RECIST v. 1.1
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): NCT03781960
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Thomas Karasic, MD||Abramson Cancer Center of the University of Pennsylvania|