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 : Active, not recruiting
First Posted : July 31, 2019
Last Update Posted : October 31, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Nivolumab Drug: Ipilimumab Drug: Sorafenib Drug: lenvatinib||Phase 3|
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||732 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 30, 2019|
|Estimated Primary Completion Date :||May 6, 2024|
|Estimated Study Completion Date :||January 4, 2025|
|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
|Study Director:||Bristol-Myers Squibb||Bristol-Myers Squibb|