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

NCT03299946

Description:

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.

Related Conditions:
  • Hepatocellular Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: J17136
  • SECONDARY ID: IRB00149350
  • NCT ID: NCT03299946

Conditions

  • Locally Advanced Hepatocellular Carcinoma

Interventions

DrugSynonymsArms
CabozantinibXL184Arm 1
NivolumabOPDIVO, BMS 936558, MDX-1106, ONO-4538Arm 1

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Arm 1Experimental
  • Cabozantinib
  • Nivolumab

Eligibility Criteria

        Inclusion Criteria:

          1. Must have locally advanced/borderline resectable hepatocellular carcinoma.

          2. Must have measurable disease.

          3. Age ≥18 years.

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

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

          6. Patients must have adequate liver remnant and function.

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

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

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

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

        Exclusion Criteria:

          1. Fibrolamellar carcinoma or mixed HCC.

          2. Chemotherapy, radiotherapy, investigational therapy, or surgery less than 6 months
             prior to trial registration.

          3. Concomitant Anticoagulation therapy.

          4. Any GI or pulmonary risks of bleeding.

          5. History of HIV Infection.

          6. Active co-infection with hepatitis B and hepatitis C.

          7. Active co-infection with hepatitis B and hepatitis D.

          8. Has a diagnosis of immunodeficiency, or is receiving systemic steroid therapy.

          9. History of any autoimmune disease requiring systemic treatment within the past 2
             years. Any patient bearing an allograft is not eligible.

         10. 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.

         11. Uncontrolled intercurrent illness.

         12. Corrected QT interval calculated by the Fridericia formula.

         13. Uncontrolled high blood pressure.

         14. Are pregnant or breastfeeding.

         15. Any gastrointestinal (GI) disorders.

         16. Any certain study-specified heart conditions 6 months prior to enrollment.

         17. Major surgery within 2 months before enrollment.

         18. Have any evidence of moderate or severe ascites.

         19. Any untreated or incompletely treated varices with bleeding or high-risk bleeding.

         20. Inability to swallow intact tablets.

         21. Known or suspected hypersensitivity to study treatment.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of adverse events in participants of neoadjuvant cabozantinib plus nivolumab.
Time Frame:4 years
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Percentage of participants who obtain R0 resection.
Time Frame:4 years
Safety Issue:
Description:
Measure:Percentage of participants who obtain a pathologic complete response (CR).
Time Frame:4 years
Safety Issue:
Description:
Measure:Percentage of participants who obtain a major pathologic responses (MPR)
Time Frame:4 years
Safety Issue:
Description:
Measure:Objective response rate (ORR)
Time Frame:4 years
Safety Issue:
Description:
Measure:Median Overall Survival (OS)
Time Frame:5 years
Safety Issue:
Description:
Measure:Disease free survival (DFS)
Time Frame:5 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • Nivolumab
  • Cabozantinib
  • Neoadjuvant
  • Immunotherapy
  • Liver Cancer
  • Borderline Resectable
  • Advance Resectable
  • Neoplasms
  • Hepatocellular Carcinoma
  • HCC
  • Resection

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