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Atezolizumab in Combination With a Multi-Kinase Inhibitor for the Treatment of Unresectable, Locally Advanced, or Metastatic Liver Cancer

ConditionsLocally Advanced Hepatocellular CarcinomaMetastatic Hepatocellular CarcinomaStage III Hepatocellular Carcinoma AJCC v8Stage IIIA Hepatocellular Carcinoma AJCC v8Stage IIIB Hepatocellular Carcinoma AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademic and Community Cancer Research United

About this trial

This phase II trial tests whether atezolizumab in combination with a multi-kinase inhibitor (cabozantinib or lenvatinib) compared to multi-kinase inhibitor alone in treating patients with liver cancer that cannot be removed by surgery (unresectable), has spread to has spread to nearby tissue or lymph nodes (locally advanced), or has spread to other places in the body (metastatic), for which the patient has received treatment in the past (previously treated). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib and lenvatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cabozantinib or lenvatinib may kill more tumor cells in patients with liver cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provide written informed consent =< 28 days prior to randomization

Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

NOTE: During the Active Monitoring Phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up

Age >= 18 years

Disqualifiers

Known diagnosis of fibrolamellar carcinoma, sarcomatoid carcinoma or mixed hepatocellular cholangiocarcinoma

Prior multi-kinase inhibitor treatment for advanced disease (e.g., cabozantinib, lenvatinib, sorafenib, regorafenib)

NOTE: Use of multi-kinase inhibitor(s) for adjuvant or as part of loco-regional therapies is allowed as long as the therapy was completed >= 6 months prior to randomization

Major surgery =< 4 weeks prior to randomization; Minor surgery =< 7 days prior to randomization (e.g., simple excision, tooth extraction, insertion of central lines/Mediport). Subjects with clinically relevant complications from prior surgery are not eligible

Trial design

Design model

Parallel

Treatments tested in this trial

  • Atezolizumab

    Biological/Vaccine

    Given IV

  • Cabozantinib

    Drug

    Given PO

  • Lenvatinib

    Drug

    Given PO

Treatment groups

122 Participants
are divided into 2 treatment groups
Group A: Arm A (atezolizumab, cabozantinib or lenvatinib)Experimental treatment 3 interventions
Group B: Arm B (cabozantinib or lenvatinib)Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

The final analysis for OS will be conducted when 84 OS events are observed, approximately 36 months after first subject in and will be evaluated with a one-sided p-value from stratified log-rank test.

Time frame
From randomization to death from any cause, assessed up to 3 years
2

Progression-free survival (PFS)

PFS analysis will be conducted when 89 PFS events are observed. The one-sided p-value from stratified log-rank test will be used for decision making.

Time frame
From randomization to first documentation of disease progression (per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) or death, assessed up to 2 years

Secondary outcomes

1

Objective response rate (ORR)

Objective response is defined as either a complete response (CR) or partial response (PR) (as defined by the RECIST 1.1). ORR will be calculated by the number of subjects experience objective response divided by the number of evaluable subjects in each arm. Confidence intervals for the ORR will be calculated using a normal approximation and the corresponding 95% confidence interval will be reported.

Time frame
Up to 2 years
2

Duration of response

For subjects who experience a CR or PR, duration of response is defined as the time from the date of first response (CR or PR) to progression or death, whichever is earliest. Median duration for each arm and corresponding 95% confidence interval, calculated using Kaplan-Meier method and Brookmeyer-Crowley, will be reported.

Time frame
Up to 2 years
3

Incidence of adverse events (AEs)

Common Terminology Criteria for Adverse Events (CTCAE) AEs will be recorded for each subject. The overall adverse event rates for grade 3 or higher AEs will be reported by arm.

Time frame
Up to 30 days after last dose

Other outcomes

Sponsors and contacts

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

Academic and Community Cancer Research United

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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