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Nivolumab for Liver Cancer
(CheckMate 9DX Trial)

Recruiting in Palo Alto (17 mi)

+355 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for individuals with Hepatocellular Carcinoma (HCC) who have had surgery or ablation and are at high risk of the cancer coming back. It's open to those with non-viral related HCC, HBV-HCC, or HCV-HCC, a good performance status, and no prior treatments for HCC. People can't join if they've had certain types of liver cancer, evidence of spread, previous cancer therapies including transplant or are on a transplant waiting list.

Inclusion Criteria

I had surgery or ablation for liver cancer as my first treatment.

My liver cancer is not caused by a virus, or it's due to hepatitis B or C.

I am fully active or restricted in physically strenuous activity but can do light work.

See 1 more

Exclusion Criteria

I have had treatments for liver cancer before.

I have not received a live vaccine in the last 30 days.

My cancer has spread or I have more than one type of cancer.

See 3 more

Treatment Details

Interventions

Nivolumab (Checkpoint Inhibitor)
Placebo ()

Trial OverviewThe study is testing whether Nivolumab can prevent cancer from returning in patients who've undergone curative treatment for liver cancer compared to a placebo. Participants will be randomly assigned to receive either Nivolumab or a placebo without knowing which one they're getting.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm AExperimental Treatment1 Intervention

Group II: Arm BPlacebo Group1 Intervention

Nivolumab is already approved in Canada, Switzerland for the following indications:

Approved in Canada as Opdivo for:

Melanoma
Non-small cell lung cancer
Renal cell carcinoma
Hodgkin lymphoma
Head and neck squamous cell carcinoma
Urothelial carcinoma
Colorectal cancer
Gastric cancer
Gastroesophageal junction cancer
Esophageal adenocarcinoma

Approved in Switzerland as Opdivo for:

Melanoma
Non-small cell lung cancer
Renal cell carcinoma
Hodgkin lymphoma
Head and neck squamous cell carcinoma
Urothelial carcinoma
Colorectal cancer
Gastric cancer
Gastroesophageal junction cancer
Esophageal adenocarcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis