Abemaciclib and Nivolumab for Subjects With Hepatocellular Carcinoma

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT03781960
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 31, 2019
Status verified
Nov 2022
Primary completion
Apr 29, 2022
Completion
Apr 29, 2022

Study Design

Enrollment
7 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Objective Response Rate [ Time Frame: up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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