Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT05174650
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Intrahepatic Cholangiocarcinoma

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Infusion i.v. of atezolizumab on day 1 of a 3-week cycle, first infusion rate over 60 minutes, subsequent infusion rates 30 minutes if tolerated for a maximum of 20 cycles in total
  • Derazantinib — DRUG
    Oral intake of 300 mg derazantinib continuously on day 1 to day 21 of a 3-week cycle for a maximum of 20 cycles in total

Study Details

The study trial is a open-label, single-arm, multicenter phase II trial investigating the combined treatment of atezolizumab and derazantinib in patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements

Key Dates

Start date
Apr 20, 2022
Status verified
Apr 2025
Primary completion
Dec 31, 2025
Completion
Aug 31, 2026

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combined treatment with Atezolizumab and Derazantinib
    Treatment with Atezolizumab 1200 mg i.v. every 3 weeks and Derazantinib 300 mp p.o. once daily for a maximum of 60 weeks or until disease progression or unacceptable toxicity or study termination

Primary Outcome Measure

Primary Objective: Assessment of Efficacy [ Time Frame: up to 4 years, at EOS ]

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