OncoMatch/Clinical Trials/NCT05257590
CVM-1118 in Combination With Nivolumab for Unresectable Advanced Hepatocellular Carcinoma
Is NCT05257590 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Immunotherapy
Other
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.
Frequently asked questions
Is NCT05257590 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage BCLC STAGE B NOT APPROPRIATE FOR OR WITH DISEASE PROGRESSION AFTER LOCAL REGIONAL THERAPY or BCLC STAGE C is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages