Status:
COMPLETED
Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
Exelixis
Bristol-Myers Squibb
Conditions:
Locally Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 Criteria
Inclusion
- 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.
Exclusion
- Fibrolamellar carcinoma or mixed HCC.
- Chemotherapy, radiotherapy, investigational therapy, or surgery less than 6 months prior to trial registration.
- Concomitant Anticoagulation therapy.
- Any GI or pulmonary risks of bleeding.
- History of HIV Infection.
- Active co-infection with hepatitis B and hepatitis C.
- Active co-infection with hepatitis B and hepatitis D.
- Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy.
- History of any autoimmune disease requiring systemic treatment within the past 2 years. Any patient bearing an allograft is not eligible.
- Any additional malignancies with treatment or life-limiting cancers. Superficial bladder cancer, non-melanoma skin cancers, or low grade prostate cancer not requiring therapy would not exclude participation in this trial.
- Uncontrolled intercurrent illness.
- Corrected QT interval calculated by the Fridericia formula.
- Uncontrolled high blood pressure.
- Are pregnant or breastfeeding.
- Any gastrointestinal (GI) disorders.
- Any certain study-specified heart conditions 6 months prior to enrollment.
- Major surgery within 2 months before enrollment.
- Have any evidence of moderate or severe ascites.
- Any untreated or incompletely treated varices with bleeding or high-risk bleeding.
- Inability to swallow intact tablets.
- Known or suspected hypersensitivity to study treatment.
Key Trial Info
Start Date :
May 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03299946
Start Date
May 14 2018
End Date
October 1 2021
Last Update
September 3 2024
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21231