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 range18 Years
SexALL
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
✕. \>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
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
. 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