Fedratinib in Combination With Nivolumab

Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Study ID
NCT05393674
Phase
PHASE2
Status
Completed

Conditions

  • Primary Myelofibrosis
  • Secondary Myelofibrosis

Eligibility Criteria

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

Interventions

  • Fedratinib Oral Capsule [Inrebic] — DRUG
    400 mg once daily p.o. from cycle 1-n, dose adjustment will be made according to the protocol
  • Nivolumab — DRUG
    240 mg every 2 weeks i.v. from cycle 2-n

Study Details

A multicenter, open-label, single arm, phase II study investigating the clinical efficacy of Fedratinib and Nivolumab combination in patients with myelofibrosis and resistance or suboptimal response to JAK-inhibitor treatment

Key Dates

Start date
Jun 14, 2022
Status verified
Dec 2025
Primary completion
Nov 5, 2025
Completion
Jan 15, 2026

Study Design

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

Arms

  • Experimental: Experimental
    Fedratinib (Cycle 1: Run-in-Phase with 400 mg QD for 4 weeks, Cycle 2-12: 400 mg QD, Dose modifications will be allowed based on observed toxicity to a 300 mg or a 200 mg daily dose) + Nivolumab (Cycle 2-12: 240 mg, i.v., q2w) Patients will receive study treatment until loss of response, death or study discontinuation for other reasons.

Primary Outcome Measure

Best response rate within 12 treatment cycles [ Time Frame: 12 months after therapy start. ]

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