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A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations

NCT03781934 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2025-07-01

No results posted yet for this study

Summary

This is an open-label, multicentre dose escalation/expansion study to assess safety and tolerability of MIV 818 as either monotherapy or in combination with 1) lenvatinib, a tyrosine kinase inhibitor used as a standard of care for the treatment of HCC or 2) pembrolizumab, a PD-1 inhibitor. The monotherapy parts of the study will include patients with various solid tumours that have spread to the liver, or alternatively originating in the liver. Evaluations of MIV-818 in combination with lenvatinib or pembrolizumab will only include patients with HCC.

Conditions

Interventions

DRUG

MIV-818 (fostroxacitabine bralpamide) + pembrolizumab

MIV-818 - oral capsules; pembrolizumab - IV

DRUG

MIV-818 (fostroxacitabine bralpamide) + lenvatinib

MIV-818 - oral capsules; lenvatinib - oral capsules

Sponsors & Collaborators

  • Medivir

    lead INDUSTRY

Principal Investigators

  • Ruth Plummer, Professor · Northern Institute for Cancer Research, Newcastle

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2025-01-07
Completion
2025-06-16

Countries

  • Belgium
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03781934 on ClinicalTrials.gov