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Checkpoint Inhibitor

Ipilimumab for Liver Cancer

Phase 2
Waitlist Available
Led By Ahmed O Kaseb
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 6 weeks of therapy, up to 5 years
Awards & highlights

Study Summary

This trial is studying nivolumab with or without ipilimumab to see how well they work in treating patients with liver cancer.

Eligible Conditions
  • Liver Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 6 weeks of therapy, up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 6 weeks of therapy, up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability of Presurgical Nivolumab With or Without Ipilimumab, Defined as the Number of Participants With of Adverse Events.
Secondary outcome measures
Objective Response Rate
Progression Free Survival (PFS)
Time to Progression
Other outcome measures
Immune response

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (ipilimumab, nivolumab)Experimental Treatment2 Interventions
Patients receive ipilimumab IV over 90 minutes on day 1 and nivolumab as Arm A. Treatment repeats every 2 weeks for up to 3 cycles for nivolumab in the absence of disease progression or unacceptable toxicity. Patients undergo liver surgery on day 1 of week 7. Beginning 4 weeks after surgery, patients receive ipilimumab IV over 90 minutes every 6 weeks and nivolumab IV over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (nivolumab)Experimental Treatment1 Intervention
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo liver surgery on day 1 of week 7. Beginning 4 weeks after surgery, patients continue nivolumab IV over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2620
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,316 Total Patients Enrolled
22 Trials studying Liver Cancer
9,411 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,824 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Ahmed O KasebPrincipal InvestigatorM.D. Anderson Cancer Center
3 Previous Clinical Trials
82 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Lancet Gastroenterology & HepatologyJournal
Perioperative Nivolumab Monotherapy Versus Nivolumab Plus Ipilimumab in Resectable Hepatocellular Carcinoma: A Randomised, Open-label, Phase 2 Trial
Kaseb, Ahmed Omar, Elshad Hasanov, Hop Sanderson Tran Cao, Lianchun Xiao, Jean-Nicolas Vauthey, Sunyoung S Lee, Betul Gok Yavuz, et al.. 2022. “Perioperative Nivolumab Monotherapy Versus Nivolumab Plus Ipilimumab in Resectable Hepatocellular Carcinoma: A Randomised, Open-label, Phase 2 Trial”. The Lancet Gastroenterology & Hepatology. Elsevier BV. doi:10.1016/s2468-1253(21)00427-1.
clinicaltrials.govStudy
Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer
2017. "Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03222076.
~4 spots leftby Apr 2025
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