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

Study at a glance

From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)

ClinicalTrials.gov ID

NCT04340193

Acronym / sponsor ID

CheckMate 74W / CA209-74W

Conditions

Cancer, Hepatocellular

Phase

Phase 3

Study type

Interventional

Recruitment status

Completed

Enrolment

26 participants (actual)

Lead sponsor

Bristol-Myers SquibbIndustry (pharma, biotech, devices)

Study start

14 Sep 2020 (actual)

Primary completion

12 Dec 2023 (actual)

Study completion

12 Dec 2023 (actual)

First posted

9 Apr 2020 (actual)

Results

Posted 26 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

None (open label)

Number of arms

3

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Adverse Events

   Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

   An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

2. Number of Participants With Serious Adverse Events (SAEs)

   Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

   Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose that results in death, Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) or requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.

3. Number of Participants Who Died

   Time frame: From first dose and 100 days after last dose of study therapy (up to approximately 27 months)

   Number of participants who died due to any cause are summarized.

4. Number of Participants With Adverse Events Leading to Study Drug Discontinuation

   Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

   An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.

5. Number of Participants With Worst Grade (Grade 3/4) Laboratory Results

   Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

   Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Highest grade measured for hemoglobin and albumin was Grade 3.

6. Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

   Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

   Blood samples were collected for specific thyroid test.

7. Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests

   Time frame: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)

   Blood samples were collected for specific liver tests.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• BMS Clinical Trial InformationLink provided by the sponsor.
• BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

107 sites in 19 countries: see every site and its status.