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A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer (CheckMate 74W)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04340193
Recruitment Status : Active, not recruiting
First Posted : April 9, 2020
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of nivolumab with and without ipilimumab in combination with Trans-arterial ChemoEmbolization (TACE) to TACE alone in participants with intermediate liver cancer.

Condition or disease Intervention/treatment Phase
Cancer, Hepatocellular Drug: nivolumab Drug: ipilimumab Procedure: TACE Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Multi-center, Double-blinded, Placebo-controlled Phase 3 Study of Nivolumab and Ipilimumab, Nivolumab Monotherapy, or Placebo in Combination With Trans-arterial ChemoEmbolization (TACE) in Patients With Intermediate-stage Hepatocellular Carcinoma (HCC)
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : January 28, 2024
Estimated Study Completion Date : January 29, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab + TACE
TACE (Trans-arterial ChemoEmbolization)
Drug: nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Drug: ipilimumab
Specified dose on specified days
Other Name: Yervoy

Procedure: TACE
TACE (Trans-arterial ChemoEmbolization)

Experimental: Nivolumab + TACE Drug: nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558

Procedure: TACE
TACE (Trans-arterial ChemoEmbolization)

Active Comparator: TACE Procedure: TACE
TACE (Trans-arterial ChemoEmbolization)




Primary Outcome Measures :
  1. Number of treated participants with adverse events (AEs) [ Time Frame: Up to 2 years and 4 months ]
  2. Number of deaths in all treated patients [ Time Frame: Up to 2 years and 4 months ]
  3. Number of treated participants with laboratory abnormalities [ Time Frame: Up to 2 years and 4 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has intermediate-stage hepatocellular carcinoma (HCC) whose tumor characteristics exceed the Beyond Milan and Up-to-7 (BMU7) criteria and is eligible for trans-arterial ChemoEmbolization (TACE)
  • Participant has no extrahepatic spreading (EHS), no regional lymph node involvement, no main, left main, or right main portal vein thrombosis, and no macrovascular invasion (MVI)
  • 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 or participants who are on the waiting list for liver transplantation
  • Active, known, or suspected autoimmune disease

Other protocol defined inclusion/exclusion criteria apply


Information from the National Library of Medicine

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): NCT04340193


Locations
Show Show 118 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04340193    
Other Study ID Numbers: CA209-74W
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: August 31, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Nivolumab
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action