Actively Recruiting
Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype
Led by Roswell Park Cancer Institute · Updated on 2026-03-24
32
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nemtabrutinib and Pembrolizumab for the Treatment of Richter Transformation, Diffuse Large B-cell Lymphoma Subtype
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with biopsy-confirmed Richter transformation, diffuse large B-cell lymphoma subtype from chronic lymphocytic leukemia or small lymphocytic lymphoma
- Ineligible for frontline anthracycline-based chemoimmunotherapy or have disease progression after prior RT-DLBCL treatment
- Recovered from adverse events of previous cancer therapies to grade 1 or baseline, or have controlled endocrine-related adverse events or grade 2 neuropathy
- Measurable disease by imaging or lab methods
- Able to swallow and keep oral medication
- Age 18 years or older at consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- No other malignancy requiring treatment within 2 years (except certain low-risk cancers)
- Adequate blood counts and organ function as specified
- HIV patients eligible if stable with CD4+ count ≥ 350 and undetectable viral load, on stable antiretroviral therapy without CYP3A4 interactions
- Hepatitis B patients eligible if on antiviral therapy with undetectable viral load
- Hepatitis C patients eligible if virus undetectable after curative therapy
- Negative pregnancy test for those of childbearing potential
- Agree to use birth control or abstain from heterosexual activity during study and 6 months after
- Able to understand and sign informed consent
You will not qualify if you...
- Prior therapy with anti-PD-1, anti-PD-L1, or other T-cell receptor targeted agents
- Recent systemic anti-cancer treatment within specified washout periods
- Recent radiotherapy within 2 weeks or radiation-related toxicities requiring steroids
- Live vaccine received within 30 days before study
- Immunodeficiency or recent high-dose steroid or immunosuppressive therapy
- Active progressing malignancy requiring treatment within 2 years (except specified exceptions)
- Active central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease needing systemic treatment in past 2 years (except certain replacement therapies)
- History or current pneumonitis/interstitial lung disease requiring steroids
- Active infection needing systemic treatment
- Not recovered from major surgery or has surgical complications
- Conditions or abnormalities interfering with study participation
- Hodgkin-like Richter transformation
- Life expectancy under 1 month
- Uncontrolled active illness including cardiac or psychiatric conditions
- Concurrent active hepatitis B and C infections
- Prolonged QT interval or significant ECG abnormalities
- Pregnant, breastfeeding, or planning pregnancy during study and 120 days after last dose
- Unwilling or unable to follow protocol
- Recent investigational agent use within 30 days
- HIV with history of Kaposi's sarcoma or multicentric Castleman's disease
- Severe bleeding disorder unless safely managed
- Psychiatric or substance abuse disorders interfering with participation
- History of allogeneic tissue or solid organ transplant
- Use of strong CYP3A4 inhibitors, inducers, or narrow therapeutic index substrates within 14 days or 5 half-lives prior to study start
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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