NCT03299946 is a Phase 1 clinical trial of Cabozantinib in Locally Advanced Hepatocellular Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

Who is sponsoring NCT03299946?

NCT03299946 is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.

What drugs are being tested in NCT03299946?

Interventions in NCT03299946: Cabozantinib, Nivolumab.

What condition does NCT03299946 study?

NCT03299946 studies Locally Advanced Hepatocellular Carcinoma.

Is NCT03299946 still recruiting?

NCT03299946 is currently completed. Last updated 3 September 2024.

Last reviewed 2024-09-03 · How we verify

NCT03299946

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 3 September 2024

What this trial tests

Phase 1 trial testing Cabozantinib in Locally Advanced Hepatocellular Carcinoma in 15 participants. Completed in 1 October 2021.

Timeline

14 May 2018

Primary endpoint
9 December 2019

1 October 2021

Quick facts

Lead sponsor	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	14 May 2018
Primary completion	9 December 2019
Estimated completion	1 October 2021
Sites	1 location across United States

Drugs / interventions tested

Cabozantinib (CABOZANTINIB) — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Locally Advanced Hepatocellular Carcinoma — all drugs for Locally Advanced Hepatocellular Carcinoma →

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →

Who can join

18 and older, any sex, with Locally Advanced Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Molecular therapies and precision medicine for hepatocellular carcinoma.
Llovet JM, Montal R, Sia D, Finn RS. · · 2018 · cited 1481× · PMID 30061739 · DOI 10.1038/s41571-018-0073-4
Targeted therapy for hepatocellular carcinoma.
Huang A, Yang XR, Chung WY, Dennison AR, et al · · 2020 · cited 548× · PMID 32782275 · DOI 10.1038/s41392-020-00264-x
Tumor Immune Microenvironment and Immunosuppressive Therapy in Hepatocellular Carcinoma: A Review.
Oura K, Morishita A, Tani J, Masaki T. · · 2021 · cited 340× · PMID 34071550 · DOI 10.3390/ijms22115801
Current perspectives on the immunosuppressive tumor microenvironment in hepatocellular carcinoma: challenges and opportunities.
Lu C, Rong D, Zhang B, Zheng W, et al · · 2019 · cited 327× · PMID 31464625 · DOI 10.1186/s12943-019-1047-6
From bench to bed: the tumor immune microenvironment and current immunotherapeutic strategies for hepatocellular carcinoma.
Fu Y, Liu S, Zeng S, Shen H. · · 2019 · cited 312× · PMID 31500650 · DOI 10.1186/s13046-019-1396-4
Neoadjuvant Cabozantinib and Nivolumab Converts Locally Advanced HCC into Resectable Disease with Enhanced Antitumor Immunity.
Ho WJ, Zhu Q, Durham J, Popovic A, et al · · 2021 · cited 282× · PMID 34796337 · DOI 10.1038/s43018-021-00234-4
The Current Landscape of Immune Checkpoint Blockade in Hepatocellular Carcinoma: A Review.
Pinter M, Jain RK, Duda DG. · · 2021 · cited 271× · PMID 33090190 · DOI 10.1001/jamaoncol.2020.3381
Targeting hypoxia in the tumor microenvironment: a potential strategy to improve cancer immunotherapy.
Wang B, Zhao Q, Zhang Y, Liu Z, et al · · 2021 · cited 189× · PMID 33422072 · DOI 10.1186/s13046-020-01820-7

Verify or expand the search:

Other trials of Cabozantinib

Trials testing the same drug.

NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07293351 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Caboz · Phase 1, PHASE2 · recruiting
NCT07187869 — Modulation of the Bone Immune Microenvironment Following Cabozantinib Treatment of Bone Metastatic Clear Cell Renal Cell · Phase 1 · not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
NCT06900595 — Testing the Addition of an Anti-Cancer Drug, Cabozantinib to the Immunotherapy Drug Cemiplimab (REGN2810), in Adolescent · Phase 2 · recruiting

Other recruiting trials for Locally Advanced Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
NCT06873269 — Holmium-166 Transarterial Radioembolization for the Treatment of Hepatocellular Carcinoma · recruiting
NCT05705492 — Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancre · Phase 2 · recruiting
NCT05377034 — Multinational Phase II Trial to Compare Safety and Efficacy of SIRT (Y-90 Resin Microspheres) Followed by Atezolizumab P · Phase 2 · recruiting
NCT05168163 — Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metast · Phase 2 · recruiting

Other Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins trials

Trials by the same sponsor.

NCT07424222 — Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE) · Phase 1 · not yet recruiting
NCT06210854 — Assessing Administration of pBI-11 Via Electroporation for the Treatment of Patients With HPV16/18+ · Phase 2 · not yet recruiting
NCT07360119 — Total Pancreatectomy With Islet Autotransplantation (TPIAT) for High-Risk Patients With Pancreatic Tumors · NA · not yet recruiting
NCT07140315 — DK222 Study at Hopkins · Phase 1 · recruiting
NCT07071155 — Momelotinib in Combination With Hypomethylating Agent for Chronic Phase Myelodysplastic Syndromes/Myeloproliferative Ove · EARLY_PHASE1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03299946 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last refreshed: 3 September 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03299946.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing