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NCT03781934
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
Phase 1, PHASE2 trial testing MIV-818 (fostroxacitabine bralpamide) + pembrolizumab in Hepatocellular Carcinoma in 53 participants. Completed in 16 June 2025.
7 January 2025
Quick facts
| Lead sponsor | Medivir |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 5 September 2018 |
| Primary completion | 7 January 2025 |
| Estimated completion | 16 June 2025 |
| Sites | 18 locations across Belgium, United Kingdom, Spain, South Korea |
Drugs / interventions tested
- MIV-818 (fostroxacitabine bralpamide) + pembrolizumab — full drug profile →
- MIV-818 (fostroxacitabine bralpamide) + lenvatinib — full drug profile →
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
- Intrahepatic Cholangiocarcinoma — all drugs for Intrahepatic Cholangiocarcinoma →
- Liver Metastases — all drugs for Liver Metastases →
Sponsor
Medivir — full company profile →
Who can join
18 and older, any sex, with Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Newest Therapies for Cholangiocarcinoma: An Updated Overview of Approved Treatments with Transplant Oncology Vision.
Zhang Y, Esmail A, Mazzaferro V, Abdelrahim M. · · 2022 · cited 20× · PMID 36291857 · DOI 10.3390/cancers14205074 -
Systemic treatment options for advanced biliary tract carcinoma.
Xie C, McGrath NA, Monge Bonilla C, Fu J. · · 2020 · cited 17× · PMID 32748173 · DOI 10.1007/s00535-020-01712-9 -
Emerging Therapies in Management of Cholangiocarcinoma.
Speckart J, Rasmusen V, Talib Z, GnanaDev DA, et al · · 2024 · cited 8× · PMID 38339363 · DOI 10.3390/cancers16030613 -
Small-molecule-based targeted therapy in liver cancer.
Ming Y, Gong Y, Fu X, Ouyang X, et al · · 2024 · cited 6× · PMID 39113358 · DOI 10.1016/j.ymthe.2024.08.001 -
Trial watch: immunotherapeutic strategies on the horizon for hepatocellular carcinoma.
Koh B, Tan DJH, Lim WH, Wong JSL, et al · · 2023 · cited 4× · PMID 37284696 · DOI 10.1080/2162402x.2023.2214478 -
Post-immunotherapy second-line strategies for hepatocellular carcinoma: State of the art and ongoing trials.
Ascari S, Chen R, De Sinno A, Stefanini B, et al · · 2026 · cited 3× · PMID 41640611 · DOI 10.3748/wjg.v32.i3.111528 -
A Phase 1a/1b Study of Fostroxacitabine Bralpamide (Fostrox) Monotherapy in Hepatocellular Carcinoma and Solid Tumor Liver Metastases.
Plummer R, Greystoke A, Naylor G, Sarker D, et al · · 2024 · cited 2× · PMID 39469286 · DOI 10.2147/jhc.s481410 -
A phase Ib/2a study of fostrox in combination with lenvatinib as second line therapy in patients with advanced hepatocellular carcinoma.
Chon HJ, Heo J, Kim DY, Lim HY, et al · · 2026 · PMID 42262258 · DOI 10.1158/1078-0432.ccr-26-0273
Verify or expand the search:
- PubMed search for NCT03781934
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Medivir trials
Trials by the same sponsor.
- NCT03443453 — A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers · Phase 1 · completed
- NCT02587962 — Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors · Phase 1, PHASE2 · terminated
- NCT02705625 — A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03781934 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medivir
- Last refreshed: 1 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03781934.
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