OncoMatch/Clinical Trials/NCT05257590
CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
Is NCT05257590 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Nivolumab and CVM-1118 for hepatocellular carcinoma.
Treatment: Nivolumab · CVM-1118 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Tumor Agnostic
Disease stage
Required: Stage BCLC STAGE B NOT APPROPRIATE FOR OR WITH DISEASE PROGRESSION AFTER LOCAL REGIONAL THERAPY, BCLC STAGE C (BCLC)
Subjects with advanced-stage, unresectable hepatocellular carcinoma that is not appropriate for potentially curable therapy... BCLC stage B not appropriate for or with disease progression after local regional therapy, or BCLC stage C
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic anti-cancer therapy (sorafenib, lenvatinib, atezolizumab in combination with bevacizumab)
progressed from, been intolerant of prior systemic anti-cancer therapies (e.g., sorafenib, lenvatinib, atezolizumab in combination with bevacizumab)
Cannot have received: immunotherapy
Prior immunotherapy for hepatoma
Lab requirements
Blood counts
ANC ≥1500/µL; Platelets ≥ 90,000/µL; HGB ≥ 9.0 g/dL
Kidney function
Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula
Liver function
Child-Pugh liver function class A; AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement); Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome); Serum albumin ≥ 2.8 gm/dL
Cardiac function
QTcF ≤ 480 msec
Adequate laboratory parameters including: AST and ALT ≤ 3.0 x ULN (≤ 5.0 x ULN if due to liver involvement); Total serum bilirubin ≤ 2.0 x ULN (≤ 3.0 x ULN for subjects with documented Gilbert's syndrome); ANC ≥1500/µL; Platelets ≥ 90,000/µL; HGB ≥ 9.0 g/dL; Serum creatinine clearance of ≥ 50 mL/min based on Cockcroft-Gault formula; Serum albumin ≥ 2.8 gm/dL; INR ≤ 2.3; PT/aPTT ≤ 1.2 x ULN; QTcF ≤ 480 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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