Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation (CheckMate 9DX)

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: NCT03383458
Recruitment Status : Active, not recruiting
First Posted : December 26, 2017
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE December 21, 2017
First Posted Date  ICMJE December 26, 2017
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE April 18, 2018
Estimated Primary Completion Date January 16, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
Recurrence-free Survival (RFS) [ Time Frame: Up to 49 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
Recurrence-free Survival (RFS) [ Time Frame: Up to 49 months ]
defined as the time from randomization to the first documented disease recurrence or death (by any cause), whichever occurs first
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2020)
  • Overall Survival (OS) [ Time Frame: Up to 7 years ]
  • Time to recurrence (TTR) [ Time Frame: Up to 49 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2017)
  • Overall Survival (OS) [ Time Frame: Up to 7 years ]
    defined by the time between the date of randomization and the date of death
  • Time to reccurence (TTR) [ Time Frame: Up to 49 months ]
    defined as the time from randomization to the first documented disease recurrence
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Nivolumab in Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Official Title  ICMJE A Phase 3, Randomized, Double-blind Study of Adjuvant Nivolumab Versus Placebo for Participants With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Brief Summary This study will investigate if nivolumab will improve recurrence-free survival (RFS) compared to placebo in participants with HCC who have undergone complete resection or have achieved a complete response after local ablation, and who are at high risk of recurrence
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Liver Cancer
Intervention  ICMJE
  • Biological: Nivolumab
    Specified dose on specified days
    Other Names:
    • Opdivo
    • BMS-936558
  • Other: Placebo
    specified dose on specified days
Study Arms  ICMJE
  • Experimental: Arm A
    Intervention: Biological: Nivolumab
  • Placebo Comparator: Arm B
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 21, 2017)
530
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date January 16, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Inclusion Criteria:

  • Participants with a first diagnosis of HCC who have undergone a curative resection or ablation
  • Participants are eligible to enroll if they have non-viral related-HCC, or if they have HBV-HCC, or HCV-HCC
  • Child-Pugh Score 5 or 6
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

Exclusion Criteria:

  • Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Any evidence of tumor metastasis or co-existing malignant disease
  • Participants previously receiving any prior therapy for HCC, including loco-regional therapies
  • Participants who have undergone a liver transplant or those who are in the waiting list for liver transplantation
  • Participants who have received a live/attenuated vaccine within 30 days of randomization (eg, varicella, zoster, yellow fever, rotavirus, oral polio and measles, mumps, rubella [MMR]).

Other protocol defined inclusion/exclusion criteria could apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   France,   Germany,   Hong Kong,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Poland
 
Administrative Information
NCT Number  ICMJE NCT03383458
Other Study ID Numbers  ICMJE CA209-9DX
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Ono Pharmaceutical Co. Ltd
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP