Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)

Who is this study for? Patients with Hepatocellular Carcinoma
What treatments are being studied? Cabozantinib+Nivolumab
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The proposed study is an open-label, single institution, single arm phase 1b study of neoadjuvant cabozantinib plus nivolumab in patients with locally advanced HCC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Must have locally advanced/borderline resectable hepatocellular carcinoma.

• Must have measurable disease.

• Age ≥18 years.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• Patients must have adequate organ and marrow function defined by study-specified laboratory tests.

• Patients must have adequate liver remnant and function.

• Antiviral therapy per local standard of care for hepatitis B.

• Woman of child bearing potential must have a negative pregnancy test.

• Must use acceptable form of birth control while on study.

⁃ Ability to understand and willingness to sign a written informed consent document.

Locations
United States
Maryland
Sidney Kimmel Comprehensive Cancer Center
Baltimore
Time Frame
Start Date: 2018-05-14
Completion Date: 2021-10-01
Participants
Target number of participants: 15
Treatments
Experimental: Arm 1
Related Therapeutic Areas
Sponsors
Collaborators: Bristol-Myers Squibb, Exelixis
Leads: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

This content was sourced from clinicaltrials.gov