NCT05393674

Fedratinib in Combination With Nivolumab

A Phase II Study of Fedratinib and Nivolumab Combination in Patients With Myelofibrosis and Resistance or Suboptimal Response to JAK-inhibitor Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The FRACTION trial will evaluate the clinical efficacy of Fedratinib and Nivolumab combination therapy in patients with primary and secondary myelofibrosis based on the consensus criteria of the International Working Group for Myelofibrosis Research and treatment (IWG-MRT), extended by the criterion RBC-transfusion independence (RBC-TI).

Conditions

• Primary Myelofibrosis
• Secondary Myelofibrosis

Interventions

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

Timeline

• Start date: 2022-06-14
• Primary completion: 2025-11-05
• Completion: 2026-01-15
• First posted: 2022-05-26
• Last updated: 2026-04-08

Locations

7 sites across 1 country: Germany