A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03383458

Acronym

CheckMate 9DX

Enrollment

545

Registered

2017-12-26

Start date

2018-04-18

Completion date

2031-05-27

Last updated

2026-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma, Liver Cancer

Brief summary

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

Interventions

BIOLOGICALNivolumab

Specified dose on specified days

OTHERPlacebo

specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Participants with a first diagnosis of HCC who have undergone a curative resection or ablation * Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC * Child-Pugh Score 5 or 6 * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion criteria

* Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC * Any evidence of tumor metastasis or co-existing malignant disease * Participants previously receiving any prior therapy for HCC, including loco-regional therapies * Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation * Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella \[MMR\]). Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame
Recurrence-free Survival (RFS)	Up to 49 months

Secondary

Measure	Time frame
Overall Survival (OS)	Up to 7 years
Time to recurrence (TTR)	Up to 49 months

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, France, Germany, Hong Kong, Italy, Japan, Mexico, Netherlands, New Zealand, Puerto Rico, Romania, Russia, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States

Contacts

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 1, 2026