Clinical Trials Logo

Clinical Trial Summary

The purpose of this clinical research study is to learn about the safety and effectiveness of cabozantinib and nivolumab in people with hepatocellular carcinoma (HCC).

Clinical Trial Description

Primary objective is to evaluate overall response rate Secondary objectives are to evaluate progression-free survival and overall survival Exploratory endpoints To explore the association between c-MET, PD-1/PD-L1 (and PD-L2) expression by immunohistochemistry, RNA seq genomic profiling and antitumor efficacy of nivolumab + cabozantinib based on RECIST 1.1 To evaluate correlation between fibrosis stage by histology, by magnetic resonance elastography (MRE) imaging and by IGF1 scores To evaluate baseline and longitudinal changes of blood and tumor markers such as TNFα, pSTAT3, and EGFR, immune cell density including frequency of PD-1 + 4-1BB + CD8+ T cells, pro-inflammatory cytokines, and hepatic fibrosis markers (APRI, FIB-4, hyaluronic acid, FibroTest [FibroSure], nonalcoholic fatty-liver disease fibrosis score, enhanced liver fibrosis [ELF]) test as biomarkers of response to therapy To evaluate candidate serum and tissue biomarkers to predict response to cabozantinib (e.g. Kallikrein 5, KLK-7, MCP-1, LAP/TGF-β1, Galectin-3) and nivolumab (e.g. angiogenin, Endostatin, PGI, PAI-1, Cystatin-B, CD8 T cell frequency and Ki67) To evaluate the predictive value of dynamic changes in fibrosis stage (defined by a minimum 2-point improvement in fibrosis grade 0-4 per MRE) and in IGF-1 blood scores ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05039736
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Sunyoung Lee
Phone 713-792-8501
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date February 28, 2022
Completion date June 30, 2023

See also
  Status Clinical Trial Phase
Recruiting NCT04209491 - Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
Active, not recruiting NCT03963206 - Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE) Phase 4
Recruiting NCT03781934 - A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations Phase 1/Phase 2
Active, not recruiting NCT03655613 - APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC Phase 1/Phase 2
Recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT04401800 - Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma Phase 2
Recruiting NCT03746704 - Study of ImmunoPet Imaging of PD-L1 in Tumors Using 89Zr-DFO-REGN3504 in Participants With Advanced PD-L1 Positive Malignancies Phase 1
Recruiting NCT04780802 - Balloon Assisted Transarterial Therapy for Hepatocellular Carcinoma N/A
Recruiting NCT04641637 - Substudy: Interconnection of Arterial Tumor Feeders Through Tumor Sinusoid in HCC N/A
Not yet recruiting NCT05044676 - Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
Recruiting NCT03970616 - A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Recruiting NCT03642561 - Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE Phase 2/Phase 3
Recruiting NCT04118114 - Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors Phase 2
Active, not recruiting NCT03222076 - Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer Phase 2
Terminated NCT03219372 - Pravastatin Intervention to Delay Hepatocellular Carcinoma Recurrence Phase 2
Completed NCT01908426 - Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib Phase 3
Not yet recruiting NCT04550663 - NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors Phase 1
Enrolling by invitation NCT04258566 - Electromagnetic Tracking and Optical Imaging With ICG for Hepatic Biopsies Phase 1
Not yet recruiting NCT05003895 - GPC3 Targeted CAR-T Cell Therapy in Advanced GPC3 Expressing Hepatocellular Carcinoma (HCC) Phase 1
Not yet recruiting NCT05009979 - 18F-DCFPyL PET/CT in Hepatocellular Carcinoma Phase 2