CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiRx, Inc.
About this trial
CVM-1118 is a new small molecule chemical entity being developed as a potential anti-cancer therapeutic by TaiRx, Inc. CVM-1118 is a potent anti-cancer agent in numerous human cancer cell lines. The safety of administrating CVM-1118 on human has been evaluated from the phase 1 study. The objective of the phase 2 study is to further investigate the efficacy of CVM-1118 with nivolumab for subjects with unresectable advanced hepatoma.
Eligibility criteria
Qualifiers
Age 18+ (20+ for subjects in Taiwan)
Diagnosis of hepatocellular carcinoma
Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) criteria (i.e., radiologic imaging with cross-sectional multiphasic contrast CT or MRI showing a ≥ 1 cm liver lesion)
Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy who have progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab).
Disqualifiers
HCC with portal vein invasion at the main portal branch (Vp4)
Known history of esophageal varices or gastrointestinal bleeding within the past 3 months
Prior immunotherapy for hepatoma
≤ 7 days from prior limited field palliative irradiation therapy and C1D1
Trial design
Treatments tested in this trial
- Nivolumab Injection [Opdivo]
- CVM-1118
Treatment groups
95 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov