Durvalumab and Tremelimumab in Combination With Y-90 SIRT for Intermediate Stage HCC

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT04522544
Phase
PHASE2
Status
Recruiting
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Conditions

  • HCC
  • Hepatocellular Carcinoma Non-resectable

Eligibility Criteria

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

Interventions

  • Tremelimumab — DRUG
    300 mg Tremelimumab C1D1
  • Durvalumab — DRUG
    1500 mg Durvalumab C1D1 + Q4W (max. 13 cycles)
  • Y-90 SIRT — PROCEDURE
    Locoregional therapy will be performed as a standard-of-care procedure
  • DEB-TACE — PROCEDURE
    Locoregional therapy will be performed as a standard-of-care procedure

Study Details

A Phase II study of immunotherapy with Durvalumab (MEDI4736) and Tremelimumab in combination with Y-90 SIRT for intermediate stage HCC

Key Dates

Start date
Dec 15, 2020
Status verified
Feb 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SIRT (Arm A)
    Y-90 SIRT + Tremelimumab + Durvalumab
  • Experimental: TACE (Arm B)
    DEB-TACE + Tremelimumab + Durvalumab

Primary Outcome Measure

Objective response rate (ORR) [according to RECIST 1.1] at 6 months. [ Time Frame: 6 months ]

Central Contacts

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