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Study Comparing BGB-B2033 With Sorafenib or Lenvatinib in Relapsed Hepatocellular Carcinoma

ConditionsHepatocellular CarcinomaLiver Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

The goal of this clinical trial is to learn how well BGB-B2033 works and how safe it is in people with hepatocellular carcinoma (HCC) who have previously received up to two treatments that included programmed cell death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) medicines. Researchers will compare BGB-B2033 with either sorafenib or lenvatinib chosen by the study doctor to see which treatment works better and is safer.

The main questions it aims to answer are:

* Does BGB-B2033 help control or slow the growth of liver cancer? * What medical problems or side effects do participants have while taking BGB-B2033? * Does BGB-B2033 help to prolong the survival for liver cancer participants over Lenvatinib/sorafenib?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have histologically confirmed Hepatocellular Carcinoma (HCC) that is not amenable to curative surgical or locoregional therapies.

Participants must have documented disease progression or intolerance after at least 1 but not exceeding 2 prior lines of systemic therapy containing Programmed Cell Death Protein 1 / Programmed Death-Ligand 1 (PD-1/PD-L1). Prior cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) targeting therapy or v ascular endothelial growth factor (VEGF) is permitted but not required.

Glypican-3 (GPC3) expression level must be known for stratification.

Participants must have at least 1 measurable lesion as assessed by RECIST v1.1

Disqualifiers

Prior therapy targeting GPC3 or 4-1BB

Participants not feasible to be treated with lenvatinib or sorafenib

prior exposure to both medications

siginificant precautions of administering lenvatinib or sorafenib such as clinically significant active bleeding within 3 months prior to first dose, tumor thombus involving main portal vein trunk, inferior vena cava, or cardiac involvement,

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGB-B2033

    Drug

    Administered intravenously

  • Lenvatinib

    Drug

    Administered by mouth as an oral capsule once daily

  • Sorafenib

    Drug

    Administered by mouth as an oral tablet twice daily

Treatment groups

492 Participants
are divided into 2 treatment groups
Group A: BGB-B2033Experimental treatment 1 intervention
Group B: Investigator's choice: Lenvatinib OR sorafenibActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

OS is defined as the time from randomization to the date of death from any cause.

Time frame
Up to approximately 3.5 years

Secondary outcomes

1

Overall Response Rate (ORR)

Defined as the percentage of participants who achieved complete response (CR) or partial response (PR) by investigator assessment and Blinded Independent Central Review (BICR) with confirmation per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Time frame
Up to approximately 3.5 years
2

Duration of Response (DOR)

DOR is defined as the time from the date that a confirmed response (CR or PR) was first observed to the date of first documented disease progression or death, whichever occurred first. Assessed by BIRC and investigator with confirmation per RECIST v1.1.

Time frame
Up to approximately 3.5 years
3

Progression Free Survival Rate (PFS)

PFS is defined as time from start of treatment to the first documentation of disease progression or death, whichever occurs first as determined by investigator assessment and BIRC with confirmation per RECIST v1.1

Time frame
Up to approximately 3.5 years
4

Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Immune-Related Adverse Events (imAEs)

Safety will be assessed by monitoring and recording of all adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v6.0.

Time frame
From first dose until either 30 days after the last dose of study drug(s) or initiation of new anticancer therapy, whichever occurs first (Up to approximately 3.5 years)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

BeOne Medicines

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: