A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (CheckMate 9DW)

• ClinicalTrials.gov Identifier: NCT04039607
• Recruitment Status: Active, not recruiting
• First Posted: July 31, 2019
• Last Update Posted: May 2, 2024
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Tracking Information

• First Submitted Date: July 30, 2019
• First Posted Date: July 31, 2019
• Last Update Posted Date: May 2, 2024
• Actual Study Start Date: September 30, 2019
• Estimated Primary Completion Date: September 30, 2026 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 30, 2019): Overall Survival (OS) [ Time Frame: Up to 4 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 30, 2019)

• Objective Response Rate (ORR) [ Time Frame: Up to 4 years ]
• Duration of Response (DOR) [ Time Frame: Up to 4 years ]
• Time to Symptom Deterioration (TTSD) [ Time Frame: Up to 4 years ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
• Official 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
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Hepatocellular Carcinoma

Intervention

• Drug: Nivolumab
  Participants will receive nivolumab as intravenous (IV) infusion.
• Drug: Ipilimumab
  Participants will receive ipilimumab as IV infusion.
• Drug: Sorafenib
  Participants will receive sorafenib as oral tablets.
• Drug: lenvatinib
  Participants will receive lenvatinib as oral capsules.

Study Arms

• Experimental: Nivolumab + Ipilimumab
  Interventions:

  • Drug: Nivolumab
  • Drug: Ipilimumab
• Active Comparator: Sorafenib/lenvatinib
  Interventions:

  • Drug: Sorafenib
  • Drug: lenvatinib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 27, 2022): 732
• Original Estimated Enrollment (submitted: July 30, 2019): 1084
• Estimated Study Completion Date: September 30, 2026
• Estimated Primary Completion Date: September 30, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, New Zealand, Poland, Puerto Rico, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, United Kingdom, United States
• Removed Location Countries: Greece

Administrative Information

• NCT Number: NCT04039607
• Other Study ID Numbers: CA209-9DW
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bristol-Myers Squibb
• Original Responsible Party: Same as current
• Current Study Sponsor: Bristol-Myers Squibb
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

• PRS Account: Bristol-Myers Squibb
• Verification Date: May 2024