Nivolumab for Liver Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Liver CancerNivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial studies nivolumab and ADI-PEG 20 before surgery to see if it can effectively treat patients with resectable liver cancer.

Eligible Conditions
  • Liver Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Up to 2 years post-treatment

Year 2
Recurrent-free survival (RFS)
Year 2
Overall survival (OS)
Year 2
Immune biomarker analysis
Necrosis of tumors
Rate of pathologic complete response
Time-to-progression (TTP)
Day 30
Incidence of adverse events (AEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (nivolumab, pegargiminase)
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Nivolumab · No Placebo Group · Phase 2

Treatment (nivolumab, pegargiminase)Experimental Group · 3 Interventions: Resection, Nivolumab, Pegargiminase · Intervention Types: Procedure, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Resection
2021
Completed Phase 2
~400
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years post-treatment

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,802 Previous Clinical Trials
1,788,893 Total Patients Enrolled
20 Trials studying Liver Cancer
7,539 Patients Enrolled for Liver Cancer
Sunyoung LeePrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
45 Total Patients Enrolled
1 Trials studying Liver Cancer
30 Patients Enrolled for Liver Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Treatment for HCC must be performed in a specialty center with expertise in liver transplantation and/or liver transplantation surgery.
You have a disease that can be accurately measured in at least one dimension and measures ≥ 15 mm or ≥ 10 mm with more sensitive techniques.
Must have ECOG PS score =< 1.
Hemoglobin > 9.0 g/dL (may be transfused or receive epoetin alfa [e.g.