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

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ClinicalTrials.gov Identifier: NCT04340193
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : August 25, 2021
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to compare effectiveness and safety 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
Liver Cancer Biological: nivolumab Biological: ipilimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 765 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 : February 26, 2026
Estimated Study Completion Date : June 10, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Arm Intervention/treatment
Experimental: Nivolumab + Ipilimumab + TACE
TACE (Trans-arterial Chemoembolization)
Biological: nivolumab
specified dose on specified days

Biological: ipilimumab
specified dose on specified days

Experimental: Nivolumab + Ipilimumab Placebo + TACE
TACE (Trans-arterial Chemoembolization)
Biological: nivolumab
specified dose on specified days

Biological: ipilimumab
specified dose on specified days

Placebo Comparator: Nivolumab Placebo + Ipilimumab Placebo + TACE
TACE (Trans-arterial Chemoembolization)
Biological: nivolumab
specified dose on specified days

Biological: ipilimumab
specified dose on specified days




Primary Outcome Measures :
  1. Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm A versus Arm C [ Time Frame: up to 2 years ]
  2. Overall Survival (OS): Arm A versus Arm C [ Time Frame: up to 2.5 years ]

Secondary Outcome Measures :
  1. Time to TACE progression (TTTP) will be assed by the blinded independent central review (BICR): Arm B versus Arm C [ Time Frame: up to 2 years ]
  2. Overall Survival (OS): Arm B versus Arm C [ Time Frame: up to 2.5 years ]
  3. Event-Free Survival (EFS) [ Time Frame: up to 2 years ]
  4. Progression-free survival (PFS) [ Time Frame: up to 2 years ]


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

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Participant has intermediate-stage HCC (hepatocellular carcinoma) whose tumor characteristics exceed the BMU7 criteria and is eligible for TACE
  • Participant has histologic confirmation of HCC
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Men and Women must agree to follow methods of contraception
  • Participants are eligible to enroll if they have non-viral related HCC, or if they have HBV-HCC, or HCV-HCC

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
  • Participants with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications
  • Any previous TACE or TAE (trans-arterial embolization without instillation of chemotherapy agent) procedure for HCC
  • Known or suspected allergy to nivolumab, ipilimumab, or study drug components given in association with this trial

Other protocol defined inclusion/exclusion criteria could 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


Contacts
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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 #.

Locations
Show Show 192 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 25, 2021
Last Verified: August 2021

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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