A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma (CheckMate 9DW)
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|ClinicalTrials.gov Identifier: NCT04039607|
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : November 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Nivolumab Drug: Ipilimumab Drug: Sorafenib Drug: lenvatinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1084 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||September 16, 2019|
|Estimated Primary Completion Date :||September 16, 2023|
|Estimated Study Completion Date :||September 16, 2023|
|Experimental: Nivolumab + Ipilimumab||
Participants will receive nivolumab as intravenous (IV) infusion.
Participants will receive ipilimumab as IV infusion.
|Active Comparator: Sorafenib/lenvatinib||
Participants will receive sorafenib as oral tablets.
Participants will receive lenvatinib as oral capsules.
- Overall Survival (OS) [ Time Frame: Up to 4 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039607
|Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,||please email:||Clinical.Trials@bms.com|
|Contact: First line of the email MUST contain NCT# and Site #.|
Show 205 Study Locations
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|