Nemtabrutinib and Pembrolizumab in Patients With Richter Transformation: A Phase II Study
Roswell Park Cancer Institute
Summary
This phase II trial tests how well nemtabrutinib in combination with pembrolizumab works in treating patients with Richter transformation, diffuse large B-cell lymphoma subtype (RT-DLBCL). Nemtabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cells (a type of white blood cell) in cancers such as Richter transformation at abnormal levels. This may help keep cancer cells from growing and spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving nemtabrutinib in combination with pembrolizumab may kill more cancer cells in patients with RT-DLBCL.
Description
PRIMARY OBJECTIVE: I. To evaluate the preliminary efficacy of nemtabrutinib and pembrolizumab as measured by the overall response rate (ORR) after 6 cycles for enrolled patients with Richter transformation, diffuse large B-cell lymphoma subtype (RT-DLBCL). SECONDARY OBJECTIVES: I. To further evaluate preliminary efficacy as measured by complete response rate (CRR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) for enrolled patients. II. To evaluate the safety and tolerability of nemtabrutinib and pembrolizumab combination treatment for RT-DLBCL. II…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with biopsy-proven Richter transformation, diffuse large B-cell lymphoma subtype (RT-DLBCL) from an antecedent or concurrently diagnosed chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL). * Be ineligible for frontline anthracycline-based chemoimmunotherapy (determined by treating investigator) OR have clinical evidence of disease progression after any prior treatment for RT-DLBCL. * Participants who have adverse events (AEs) due to previous anti-cancer therapies must have recovered to ≤ grade 1 or baseline. Participants with endocrine-re…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureComputed Tomography
Undergo PET/CT or CT
- ProcedureEchocardiography
Undergo ECHO
- ProcedureMultigated Acquisition Scan
Undergo MUGA
- DrugNemtabrutinib
Given PO
- BiologicalPembrolizumab
Given IV
Location
- Roswell Park Cancer InstituteBuffalo, New York