Emavusertib (CA-4948) in Patients with Relapsed or Refractory Primary Central Nervous System Lymphoma
About the Emavusertib (CA-4948) trial in patients with relapsed or refractory Primary Central Nervous System Lymphoma
The Ivy Brain Tumor Center at Barrow Neurological Institute, a nonprofit translational research program, is conducting a Phase 1/2 study to evaluate emavusertib (CA-4948) in patients with relapsed or refractory (R/R) primary central nervous system lymphoma (PCNSL). This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with R/R hematologic malignancies.
Emavusertib is a first-in-class suppressor of IRAK4, a key driver of the toll-like receptor (TLR) pathway. It is a novel and highly selective oral kinase inhibitor that targets key proteins that are the cause of several B-cell lymphomas. Ibrutinib is a kinase inhibitor and is used to treat adults with primary central nervous system lymphoma and other cancers such as chronic lymphocytic leukemia, small lymphocytic lymphoma, and Waldenstrom’s macroglobulinemia.
The primary objective of this study is to assess the anti-cancer activity of emavusertib in combination with ibrutinib in patients with R/R PCNSL. It is also assessing the contribution of components, i.e., emavusterib as a monotherapy and ibrutinib monotherapy
Emavusertib (CA-4948) Trial Details
Recruiting
Emavusertib (CA-4948
Ibrutinib
Relapsed or Refractory Primary Central Nervous System Lymphoma
152 Participants
NCT03328078
Curis, Inc.
You may be eligible if:
- You are 18 years or older.
- Histopathologically confirmed diagnosis of PCNSL (medical record is acceptable). Cerebral biopsies are not required if imaging reveals typical images of PCNSL.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
View all eligibility criteria by visiting ClinicalTrials.gov or call 602-406-8605 to speak with a patient navigator.
How it works
Part B:
In two Cohorts, emavusertib in combination with ibrutinib will be orally administered to participants with R/R PCNSL who have progressed on a BTKi.
In Cohort 1, emavusertib will be administered twice daily at 100 mg with ibrutinib once daily consecutively in 28-day treatment cycles.
In Cohort 2, a higher dose emavusertib (200 mg) will be administered twice daily with ibrutinib once daily consecutively in 28-day treatment cycles.
Part C:
In this part of the study, PCNSL patients who have only had 1 prior line of treatment and are naïve to BTKi treatment will receive 1 of 3 treatment arms:
Higher dose emavusertib (200 mg) twice daily,
Ibrutinib once daily, or
Higher dose emavusertib (200 mg) twice daily in combination with ibrutinib once daily.
Treatments will be administered continuously in 28-day treatment cycles. Patients who progress while on treatment arms (1) or (2) can cross-over to the combination arm.
Am I eligible?
Submit a free trial screening request today to learn if you may qualify for any of our studies.
