NCT03781960

Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma

Phase II Trial of Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the effectiveness of the combination of nivolumab and abemaciclib for the treatment of hepatocellular carcinoma. Other goals of this study are to learn about the side effects that this combination of drugs may cause and to learn more about how these drugs work by studying blood and tissue.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Abemaciclib	Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
DRUG	Nivolumab	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.

Timeline

• Start date: 2019-07-31
• Primary completion: 2022-04-29
• Completion: 2022-04-29
• First posted: 2018-12-20
• Last updated: 2022-12-14
• Results posted: 2022-12-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study