Fedratinib in Combination With Nivolumab (NCT05393674) | Clinical Trial Compass
CompletedPhase 2
Fedratinib in Combination With Nivolumab
Germany30 participantsStarted 2022-06-14
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed Informed Consent Form available and patient willing and able to adhere to the study visit schedule and other protocol requirements.
. Patients\* ≥18 years of age
. diagnosed with myelofibrosis (MF) according to the WHO 2008 or 2016 criteria, including primary (pre-fibrotic or overt) and secondary myelofibrosis.
. Patients with an indication for therapy (either symptomatic patients with splenomegaly \>11cm diameter and/or symptoms restricting their daily activity or patients with DIPSS int-2, or high risk or MIPSS70 int or high)
. Patients with no response or suboptimal response to any JAK-inhibitor therapy (regarding persistence of symptoms, splenomegaly, cytopenia or hyperproliferation) defined either by
. ECOG performance status \<3 at screening and adequate organ function
. Reliable contraception should be maintained throughout the study and for 1 month after discontinuation of Fedratinib or 5 months after discontinuation of Nivolumab\*\*
. Subject must be willing to receive transfusion of blood products
Exclusion criteria
. Planned hematopoietic stem cell transplantation within 3 months and suitable donor available
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Best response rate within 12 treatment cycles
Timeframe: 12 months after therapy start.
Trial details
NCT IDNCT05393674
SponsorInstitut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
. \>10% blasts in bone marrow smear (cytology) or \>2x in blood smear within the screening phase or \>20% blasts at any time in bone marrow or peripheral blood smears
. Creatinine \>2xULN and Creatinine-Clearance \<45ml/min; ALAT, ASAT \& bilirubin \>3xULN (if MF impact on liver \>5xULN)
. Baseline platelets count below 50 x 10\^9/L and ANC \< 1.0 x 10\^9/L
. Diagnosis of PV, ET (according to WHO 2016) or positive molecular test for BCR-ABL
. Patients on ongoing medication for myelofibrosis including systemic corticosteroids (detailed list of permitted medications is provided in paragraph 9.1.10.4 and Appendix V). Use of steroids within 14 days prior to the first dose of study drug and until end of treatment is prohibited by patients.
. Uncontrolled infection
. Evidence of acute or chronic infection with hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or tuberculosis