Trial purpose
Cancer treatment
Tumor type
Upper gastrointestinal tract
Age
18+
Trial acronym
CheckMate 9DW
Clinical summary
Summary
Eligible patients will be randomised to receive the experimental (Nivolumab + Ipilimumab) or comparative treatment (Sorafenib or lenvatinib).
Conditions
This trial is treating people with hepatocellular (liver) cancer
Eligibility
Inclusion
- 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
- 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.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Bristol-Myers Squibb (BMS)
Scientific 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
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