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Monoclonal Antibodies

Nivolumab for Liver Cancer

Phase 2

Waitlist Available

Led By Sunyoung Lee

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 up to 2 years post-treatment

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events (AEs)

Necrosis of tumors

Rate of pathologic complete response

Secondary outcome measures

Overall survival (OS)

Recurrent-free survival (RFS)

Time-to-progression (TTP)

Other outcome measures

Immune biomarker analysis

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (nivolumab, pegargiminase)Experimental Treatment3 Interventions

Patients receive nivolumab IV over 30 minutes on day 1 and pegargiminase IM at 2 days before day 1 of cycle 1, day 8 of cycle 1, days 1 and 8 of cycle 2, and day 1 of cycle 3. Treatments repeat every 2 weeks for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care surgical resection at week 7. A cycle is 14 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

Resection

2021

Completed Phase 2

~410

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,802 Total Patients Enrolled

22 Trials studying Liver Cancer

9,411 Patients Enrolled for Liver Cancer

Sunyoung LeePrincipal InvestigatorM.D. Anderson Cancer Center

2 Previous Clinical Trials

15 Total Patients Enrolled

1 Trials studying Liver Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the estimated participant count of this clinical investigation?

"Affirmative. Clinicaltrials.gov's data shows that this medical study, which was initially published on April 13th 2022 is actively seeking participants. The trial requires 10 individuals to be recruited at one single location."

Answered by AI

Are there any opportunities currently available to join this research trial?

"According to the information provided on clinicaltrials.gov, this medical trial is actively recruiting participants. Initially posted on April 13th 2022, it was last modified on July 10th 2022."

Answered by AI

In what situations is Nivolumab usually recommended?

"Nivolumab can serve as a useful treatment for malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

Is this research a pioneering endeavor?

"Presently, there are 720 active trials for Nivolumab across 49 countries and 2356 cities. The inaugural clinical trial of the drug was conducted in 2012 by Ono Pharmaceutical Co. Ltd with 659 participants; since then 268 trials have been completed."

Answered by AI

What prospective hazards are linked to Nivolumab?

"Despite having some safety data, the absence of efficacy information resulted in Nivolumab receiving a score of 2."

Answered by AI

Could you provide information regarding the past research initiatives related to Nivolumab?

"As of now, there are 720 trials utilizing Nivolumab across 40290 medical centres worldwide. Of these studies, 82 are in the final stages of Phase 3 testing. Notably, many clinical sites offer this therapy in Bern BE."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nivolumab and ADI-PEG 20 Before Surgery for the Treatment of Resectable Liver Cancer

2022. "Nivolumab and ADI-PEG 20 Before Surgery for the Treatment of Resectable Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04965714.