Maintenance Zanzalintinib and Durvalumab in Participants With Advanced Hepatocellular Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorAmit Mahipal
About this trial
This research study is for people who were treated with tremelimumab and durvalumab for advanced liver cancer and who are currently receiving durvalumab. Participants in this study will receive a drug called zanzalintinib. They will also continue receiving durvalumab. Studies have shown that patients with advanced liver cancer who had tremelimumab and durvalumab may benefit from taking zanzalintinib while they are taking durvalumab. Zanzalintinib is an investigational drug. This means it has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of patients with advanced liver cancer. Durvalumab is approved by the FDA for patients with advanced liver cancer. The purpose of this study is to find out if taking zanzalintinib with durvalumab will improve how long people with advanced liver cancer will live.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have radiographically or histologically or cytologically confirmed hepatocellular cancer. Participants must have advanced cancer (metastatic or unresectable) requiring systemic therapy.
Participants must be treated with tremelimumab plus durvalumab and have stable disease or response to therapy. Participants must have received 2 to 5 doses of durvalumab prior to starting treatment on the clinical trial.
Age >18 years. Because no dosing or adverse event data are currently available on the use of durvalumab in combination with zanzalintinib in participants ≤18 years of age, children are excluded from this study.
ECOG Performance status 0-2.
Disqualifiers
Inability to swallow tablets or ingest a suspension either orally or by a nasogastric (NG) or gastrostomy (PEG) tube.
Participants receiving any other investigational agents concurrently for cancer treatment.
Participants with untreated brain metastases/CNS disease will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
History of solid organ or allogeneic stem cell transplant.
Trial design
Design model
Single group
Treatments tested in this trial
Durvalumab
DrugParticipants will receive 1500 mg durvalumab through intravenous (IV) administration over a period of 60 minutes on Day 1 of each 28-day cycle.
Zanzalintinib
DrugParticipants will receive 60 mg durvalumab orally on Days 1-28 of each 28-day cycle.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Durvalumab + zanzalintinibExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Progression-Free Survival (PFS) at 16 weeks
Progression-Free Survival (PFS) is defined as the duration of time from start of treatment to time of disease progression or death, whichever occurs first.
Time frame
Week 16Secondary outcomes
1
Objective Response Rate (ORR)
ORR is the percentage of participants whose cancer got better after treatment (i.e. the percentage of participants who had CR or PR, as defined below), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame
Up to 2 years2
Safety and tolerability, as measured by incidence and severity of adverse events
Adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5. Adverse events will be assessed throughout treatment and up to 30 days after treatment discontinuation for any reason (up to 2 years total).
Time frame
Up to 2 years3
Overall Survival (OS)
Overall survival (OS) is defined as the duration of time from start of treatment to time of death from any cause.
Time frame
Until death, up to 2 years4
Clinical benefit rate
Clinical benefit rate is defined as the proportion of participants with objective responses or stable disease (SD), as defined below. ORR is the percentage of participants whose cancer got better after treatment (i.e. the percentage of participants who had CR or PR), and this will be measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Per RECIST v1.1, Complete Response (CR) is defined as disappearance of all target lesions. Partial Response (PR) is defined as a 30% decrease in the sum of diameters of target lesions. Progressive Disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of one or more new lesions. Stable Disease (SD) is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: