Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Ipilimumab

Chlorotrianisene

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Subjects receive Cabozantinib 40 mg daily on days 1-28 of a 28 day cycle, this is to be started 7-14 days after the last TACE procedure.

Nivolumab 480 mg IV on day 1 of a 28 day cycle (cycle 2 and beyond), this is to be started 7-14 days after the last TACE procedure.

Nivolumab: 3mg/kg IV on day 1 of a 21 day cycle x 1 dose.

Ipilimumab: 1 mg/kg on day 1 of a 21 day cycle x 1 dose

TACE: Within 3-4 weeks of cycle 1 day 1; may be done up to 3 times (9-12 weeks total), the intervals between each TACE treatment can vary based on investigator's discretion

Cabozantinib

TACE treatment will be administered using either the DEB-TACE or cTACE modality in a series of up to 3 individual procedures within the 9-12 weeks following Day 21 (= cycle 1 day 21) of a patient's first infusion of nivolumab/ipilimumab. The first TACE treatment should start no more than 7 working days after being cycle 1 day 21.

Transarterial Chemoembolization

Chao Family Comprehensive Cancer Center University of California, Irvine

University of California Irvine Medical

Farshid Dayanni, MD, PhD

Farshid Dayyani, MD, PhD

This is a phase 2 single-arm, open-label clinical trial determining efficacy of cabozantinib in combination with ipilimumab/nivolumab and transarterial chemoembolization (TACE) in subjects with hepatocellular carcinoma (HCC). These are subjects who are not candidates for curative intent treatment.

Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma

Phase 2 Study of Cabozantinib Combined With Ipilimumab/Nivolumab and Transarterial Chemoembolization (TACE) in Patients With Hepatocellular Carcinoma (HCC) Who Are Not Candidates for Curative Intent Treatment

This is defined as the percentage of subjects who are free of progression 6 months after study treatment start. Progression is defined death, radiographic progression or clinical deterioration attributed disease progression as judged by an investigator. Radiographic progression is defined using the modified Response Evaluation Criteria in Solid Tumors Criteria (mRECIST), as a 20% increase in the sum of diameters of of viable (enhancing) target lesions and/or appearance of one or new lesions and/or unequivocal progression of existing non-target lesions.

Complete Response (CR) is defined as the disappearance of all target lesions, determined by two separate observations conducted not less than 4 weeks apart. There can be no appearance of new lesions.

To evaluate overall survival in patients with advanced gastric and gastroesophageal adenocarcinoma treated with this combination of cabozantinib and irinotecan.

To evaluate the tolerability of administering cabozantinib in combination with cabozantinib/nivolumab and TACE in patients with hepatocellular carcinoma from the start of treatment, duration of treatment and up to 4 weeks after completion of study treatment. Toxicity and adverse events are based on the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 5.0.

Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.

Rate of subjects suitable for liver transplant according to the Milan criteria. Milan criteria is defined as single tumors ≤5 cm in diameter or no more than three tumors ≤3 cm in diameter single tumors ≤5 cm in diameter or no more than three tumors ≤3 cm in diameter

Spots Global Cancer Trial Database for Cabozantinib Combined With Ipilimumab/Nivolumab and TACE in Patients With Hepatocellular Carcinoma

Trial Identification

Conditions

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Study Description

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