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Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma

ConditionsHepatocellular Carcinoma (HCC)Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorYoon Jun Kim

About this trial

Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.

Hemoglobin ≥9.0 g/dL

Absolute neutrophil count (ANC) ≥1500 per mm3

Platelet count ≥75,000 per mm3

Disqualifiers

1. Eligible for potentially curative treatment (surgical resection, radiofrequency ablation or immediate liver transplantation).

Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.

Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and/or tremelimumab may be included at the discretion of the Investigator.

Patients with vitiligo or alopecia

Trial design

Design model

Single group

Treatments tested in this trial

  • Tremelimumab Plus Durvalumab (MEDI4736)

    Drug

    Study subjects will receive 1,500 mg of durvalumab intravenously every 4 weeks until PD is observed. However, treatment will be discontinued if unacceptable toxicity, withdrawal of consent, or any other discontinuation criteria are met. Tremelimumab will be administered first, and durvalumab infusion will begin approximately 1 hour (up to 2 hours) after the completion of tremelimumab infusion. The standard infusion time for each drug is 1 hour, but if the infusion is temporarily interrupted, the total duration should not exceed 8 hours at room temperature.

  • Transarterial chemoembolization (TACE)

    Procedure/Surgery

    TACE will be carried out 1 to 2 weeks (7 to 14 days) after the administration of tremelimumab + durvalumab, and thereafter, it will be performed as needed at the discretion of the investigator during the treatment period. If additional TACE is performed, there must be at least a 1-week interval between the additional TACE and the administration of durvalumab.

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: Tremelimumab Plus Durvalumab (MEDI4736) in Combination with Concurrent Transarterial ChemoembolizatiExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

PFS

The primary endpoint for evaluating progression-free survival (PFS) will be assessed through RECIST 1.1 evaluation.

Time frame
the time from the first study treatment administration until the date of objective disease progression

Secondary outcomes

1

OS

Overall Survival (OS) from first dose of study drug until the time of data cut-off, as determined by the Investigator.

Time frame
the time from the first study treatment administration until death due to any cause, regardless of whether the patient withdraws from therapy or receives another anticancer therapy.
2

ORR

Objective Response Rate (ORR) of Target Lesion(s) and Non-Target Lesion(s)

Time frame
From date of enrollment until the date of first documented progression, assessed every 8 weeks up to 12 months.
3

TTP

Time to progression (TTP) of enrollment to disease progression as assessed by RECIST 1.1 and mRECIST.

Time frame
the time from the first study treatment administration until the first confirmed tumor progression (PD) based on the RECIST 1.1 assessment.
4

Safety of durvalumab and tremelimumab in terms of the occurrence of adverse events

changes from baseline in vital signs (blood pressure and heart rate), and safety laboratory findings (chemistry, hematology, and so on)

Time frame
Until 30 days after TACE or the last dose of tremelimumab and/or durvalumab

Other outcomes

Sponsors and contacts

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

Yoon Jun Kim

Lead sponsor

Seoul National University Hospital

Sponsor institution

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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