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NCT03383458: CheckMate 9DX

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

Active, enrolled Phase 3 Last updated 21 November 2025
What this trial tests

Phase 3 trial testing Nivolumab in Hepatocellular Carcinoma in 545 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
18 April 2018
Primary endpoint
27 February 2026
27 February 2031

Quick facts

Lead sponsorBristol-Myers Squibb
PhasePhase 3
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment545
Start date18 April 2018
Primary completion27 February 2026
Estimated completion27 February 2031
Sites184 locations across Hong Kong, Colombia, Italy, Japan, Taiwan, South Korea, New Zealand, Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Hepatocellular Carcinoma or Liver Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Molecular therapies and precision medicine for hepatocellular carcinoma.
    Llovet JM, Montal R, Sia D, Finn RS. · · 2018 · cited 1481× · PMID 30061739 · DOI 10.1038/s41571-018-0073-4
  2. Advances in immunotherapy for hepatocellular carcinoma.
    Sangro B, Sarobe P, Hervás-Stubbs S, Melero I. · · 2021 · cited 1002× · PMID 33850328 · DOI 10.1038/s41575-021-00438-0
  3. Tumor Immune Microenvironment and Immunosuppressive Therapy in Hepatocellular Carcinoma: A Review.
    Oura K, Morishita A, Tani J, Masaki T. · · 2021 · cited 340× · PMID 34071550 · DOI 10.3390/ijms22115801
  4. Current perspectives on the immunosuppressive tumor microenvironment in hepatocellular carcinoma: challenges and opportunities.
    Lu C, Rong D, Zhang B, Zheng W, et al · · 2019 · cited 327× · PMID 31464625 · DOI 10.1186/s12943-019-1047-6
  5. From bench to bed: the tumor immune microenvironment and current immunotherapeutic strategies for hepatocellular carcinoma.
    Fu Y, Liu S, Zeng S, Shen H. · · 2019 · cited 312× · PMID 31500650 · DOI 10.1186/s13046-019-1396-4
  6. Immunobiology and immunotherapy of HCC: spotlight on innate and innate-like immune cells.
    Ruf B, Heinrich B, Greten TF. · · 2021 · cited 247× · PMID 33235387 · DOI 10.1038/s41423-020-00572-w
  7. Emerging Therapies for Hepatocellular Carcinoma (HCC).
    Chakraborty E, Sarkar D. · · 2022 · cited 236× · PMID 35681776 · DOI 10.3390/cancers14112798
  8. Emerging immunotherapy for HCC: A guide for hepatologists.
    Foerster F, Gairing SJ, Ilyas SI, Galle PR. · · 2022 · cited 185× · PMID 35253934 · DOI 10.1002/hep.32447

Verify or expand the search:

Other trials of Nivolumab

Trials testing the same drug.

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03383458.

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