Nemtabrutinib + Pembrolizumab for Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byMatthew J Cortese

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

NOT YET RECRUITING - 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.

Eligibility Criteria

This trial is for patients with a specific type of lymphoma known as Richter transformation, diffuse large B-cell subtype. It's designed to see if combining two drugs, nemtabrutinib and pembrolizumab, can effectively treat this cancer. Participants should have this particular diagnosis to join.

Inclusion Criteria

My platelet count is at least 25,000, even with transfusions.

My hemoglobin level is at least 7gm/dL, transfusions are okay.

Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

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Exclusion Criteria

I have active brain metastases or carcinomatous meningitis.

Unwilling or unable to follow protocol requirements

I am still recovering from major surgery or have complications.

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Treatment Details

Interventions

Nemtabrutinib (Kinase Inhibitor)
Pembrolizumab (Monoclonal Antibodies)

Trial OverviewThe study is testing the effectiveness of nemtabrutinib (a kinase inhibitor that targets abnormal proteins in certain white blood cells) combined with pembrolizumab (an immunotherapy drug). The goal is to determine if this combination helps control or reduce cancer growth in RT-DLBCL patients.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (nemtabrutinib, pembrolizumab)Experimental Treatment9 Interventions

Patients receive nemtabrutinib PO QD on days 1-21 of each cycle and pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening, PET/CT or CT and blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy throughout the trial.