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

ConditionsHepatocellular CarcinomaHCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Irvine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologic or radiographic diagnosis of hepatocellular carcinoma

At least one lesion amenable to TACE treatment

Child-Pugh A-B7 (B7 based on Albumin allowed)

Not a candidate for resection or transplantation

Disqualifiers

Any type of previous systemic anti-cancer treatment

All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 or baseline

Any locoregional treatment for HCC within 3 months

Vp4 or Vp3 portal vein thrombus

Trial design

Design model

Single group

Treatments tested in this trial

  • Nivolumab

    Drug

    Given IV

  • Ipilimumab

    Drug

    Given IV

  • Cabozantinib

    Drug

    Given PO

  • Transarterial Chemoembolization

    Procedure/Surgery

    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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Cabozantinib with Ipilimumab/Nivolumab and TACEExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants with Progression-free Survival at 6 Months

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.

Time frame
6 months
2

Complete Response Rate

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.

Time frame
From date of registration until first date of disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

Secondary outcomes

1

Overall Survival of Patients who Received Cabozantinib with Ipilimumab/Nivolumab and TACE

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

Time frame
From date of registration for up to 18 months after last patient is enrolled or until death from any cause, whichever came first.
2

Percentage of Grade 3-5 Adverse Events

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.

Time frame
From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
3

Progression Free Survival

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

Time frame
From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.
4

Conversion Rate to Resectable

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

Time frame
From the start date of treatment until 4 weeks after removal of treatment due to disease progression, toxicity, delay of treatment, or withdrawal of treatment, whichever came first, an average of 1 year.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Irvine

Lead sponsor

Exelixis

Collaborator

Source ClinicalTrials.gov
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