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OpenTrials
Active, not recruiting

NCT Number: NCT04039607

A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma

The main purpose of this study is to compare the overall survival (OS) of nivolumab plus ipilimumab versus standard of care (SOC) (sorafenib or lenvatinib) in all randomized participants with advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0037, Caba, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have a diagnosis of HCC based on histological confirmation
  • Participants must have an advanced HCC
  • Participants must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 measurable previously untreated lesion
  • 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
  • Prior liver transplant
  • Episodes of hepatic encephalopathy (greater than or equal to [>=] Grade 2) within 12 months prior to randomization
  • Active brain metastases or leptomeningeal metastases

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

Nivolumab

Drug

Participants will receive nivolumab as intravenous (IV) infusion.

Ipilimumab

Drug

Participants will receive ipilimumab as IV infusion.

Sorafenib

Drug

Participants will receive sorafenib as oral tablets.

Lenvatinib

Drug

Participants will receive lenvatinib as oral capsules.

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Up to 4 years

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to 4 years

  2. Duration of Response (DOR)

    Time frame: Up to 4 years

  3. Time to Symptom Deterioration (TTSD)

    Time frame: Up to 4 years

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination With Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants With Advanced Hepatocellular Carcinoma

Acronym: CheckMate 9DW

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2019
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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