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

Part of paid clinical trials in Coronado, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04340193
Phase
PHASE3
Status
Completed

Conditions

  • Cancer, Hepatocellular

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — DRUG
    Specified dose on specified days
  • ipilimumab — DRUG
    Specified dose on specified days
  • TACE — PROCEDURE
    TACE (Trans-arterial ChemoEmbolization)

Study Details

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.

Key Dates

Start date
Sep 14, 2020
Status verified
Nov 2024
Primary completion
Dec 12, 2023
Completion
Dec 12, 2023

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab + Ipilimumab + TACE
    TACE (Trans-arterial ChemoEmbolization)
  • Experimental: Nivolumab + TACE
  • Active Comparator: TACE

Primary Outcome Measure

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) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Local Institution - 0189CoronadoCalifornia92118-
Local InstitutionWashington D.C.District of Columbia20007-
Local Institution - 0005LouisvilleKentucky40202-
Local Institution - 0059LouisvilleKentucky40217-
Local Institution - 0109DallasTexas75203-

Find similar trials in Coronado, CA

By research site
Local Institution - 0189· Coronado, CALocal Institution· Washington D.C., DCLocal Institution - 0005· Louisville, KYLocal Institution - 0059· Louisville, KYLocal Institution - 0109· Dallas, TX