OncoMatch/Clinical Trials/NCT06863402
Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype
Is NCT06863402 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Nemtabrutinib for richter syndrome.
Treatment: Nemtabrutinib · Pembrolizumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anthracycline-based chemoimmunotherapy — frontline
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.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PDL2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137).
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy within 5 half-lives of last dose (or within 30 days for cellular therapy or investigational agents, or within 100 days post allogeneic hematopoietic stem cell transplantation and without any grade ≥ 2 graft versus host disease) prior to enrollment.
Cannot have received: radiotherapy
Exception: Two weeks or fewer of palliative radiotherapy for non-central nervous system (CNS) disease is permitted. The last radiotherapy treatment must have been performed at least 7 days before the first dose of study intervention.
Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation related toxicities requiring corticosteroids.
Cannot have received: live vaccine or live-attenuated vaccine
Exception: Killed or mRNA vaccines allowed
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed or messenger ribonucleic acid (mRNA) vaccines is allowed.
Cannot have received: investigational agent
Received any other investigational agent within 30 days prior to enrollment.
Lab requirements
Blood counts
Absolute neutrophil count: ANC ≥ 500 cells/µL (without G-CSF dose within the last 7 days prior to initiation of study treatment). Platelets: ≥ 25,000/µL (not requiring transfusion within the last 3 days prior to initiation of study treatment); patients on medications that increase bleeding risk must have a platelet count ≥50,000 /µL and have no history of major bleeding. Hemoglobin: ≥ 7gm/dL (transfusion support allowed).
Kidney function
Creatinine clearance (CrCl): ≥ 30 mL/min (per Cockroft-Gault equation).
Liver function
Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN. AST/ALT: ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases).
Cardiac function
Corrected QT interval (QTc) prolongation (defined as a Fridericia's corrected QT [QTcF] > 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min) [excluded].
Absolute neutrophil count: ANC ≥ 500 cells/µL (without G-CSF dose within the last 7 days prior to initiation of study treatment). Platelets: ≥ 25,000/µL (not requiring transfusion within the last 3 days prior to initiation of study treatment). Hemoglobin: ≥ 7gm/dL (transfusion support allowed). Total bilirubin: ≤ 1.5 x upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels > 1.5 x ULN. AST/ALT: ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases). Creatinine clearance (CrCl): ≥ 30 mL/min (per Cockroft-Gault equation). Corrected QT interval (QTc) prolongation (defined as a Fridericia's corrected QT [QTcF] > 450 msecs) or other significant electrocardiogram (ECG) abnormalities including second degree atrioventricular (AV) block type II, third degree AV block, or bradycardia (ventricular rate less than 50 beats/min) [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Roswell Park Cancer Institute · Buffalo, New York
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