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 (CheckMate 9DX: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 9DX)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508726-10-00

Acronym

CA209-9DX

Enrollment

145

Registered

2024-02-22

Start date

2018-03-28

Completion date

Unknown

Last updated

2026-01-09

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

Conditions

Hepatocellular Carcinoma

Brief summary

Recurrence free survival (RFS), defined as the time from randomization to the first documented disease recurrence or death (by any cause), whichever occurs first.

Detailed description

OS, defined as the time between the date of randomization and the date of death (by any cause)., Time to Recurrence (TTR), defined as the time from randomization to the first documented disease recurrence.

Interventions

DRUG0.9% Sodium Chloride injection; Solution for injection/infusion

DRUG5% Dextrose injection; Solution for injection/infusion

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Recurrence free survival (RFS), defined as the time from randomization to the first documented disease recurrence or death (by any cause), whichever occurs first.	—

Secondary

Measure	Time frame
OS, defined as the time between the date of randomization and the date of death (by any cause)., Time to Recurrence (TTR), defined as the time from randomization to the first documented disease recurrence.	—

Countries

Austria, Belgium, France, Germany, Italy, Netherlands, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026