Trial Summary
What is the purpose of this trial?This phase II trial tests how well pembrolizumab and tazemetostat work to treat patients who have received autologous stem cell transplantation (ASCT) or chimeric antigen receptor (CAR) T cell therapy for aggressive non hodgkins lymphoma. A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Tazemetostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and tazemetostat may work better to treat patients who have received ASCT or CAR-T cell therapy for aggressive non hodgkins lymphoma.
What safety data is available for Pembrolizumab and Tazemetostat in treating Non-Hodgkin's Lymphoma?The safety data for Pembrolizumab, also known as Keytruda, includes reports of immune-related adverse events (irAEs) such as pneumonitis, colitis, hepatitis, hypophysitis, hyperthyroidism, hypothyroidism, nephritis, and type 1 diabetes. These events are associated with its role as a PD-1 inhibitor used in cancer immunotherapy. While specific safety data for the combination of Pembrolizumab and Tazemetostat in Non-Hodgkin's Lymphoma is not provided in the research, Pembrolizumab has been studied in various cancers, showing a range of irAEs. Tazemetostat, known under various names, is not specifically mentioned in the provided research, so its safety profile in this combination remains to be evaluated in clinical trials.236710
Is the drug Pembrolizumab + Tazemetostat a promising treatment for Non-Hodgkin's Lymphoma?The information provided does not include any specific research or results about Pembrolizumab + Tazemetostat for Non-Hodgkin's Lymphoma, so we cannot determine if it is a promising treatment based on this data.14589
What data supports the idea that Pembrolizumab + Tazemetostat for Non-Hodgkin's Lymphoma is an effective drug?The available research does not provide specific data on the effectiveness of Pembrolizumab + Tazemetostat for Non-Hodgkin's Lymphoma. However, Pembrolizumab, one of the drugs in the combination, has been shown to be effective in treating other types of cancer, such as non-small cell lung cancer and melanoma. It works by helping the immune system attack cancer cells. There is no direct comparison or data available for its use in Non-Hodgkin's Lymphoma with Tazemetostat from the provided information.2361011
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop taking your current medications. However, patients receiving medications that are inhibitors or inducers of CYP450 enzymes are eligible as long as they meet the criteria. It's best to discuss your specific medications with the trial team.
Eligibility Criteria
This trial is for patients with aggressive B-cell Non-Hodgkin's Lymphoma who have already undergone autologous stem cell transplantation (ASCT) or chimeric antigen receptor (CAR) T-cell therapy. Specific eligibility criteria are not provided, but typically include factors like age, health status, and previous treatments.Inclusion Criteria
I have aggressive B-cell NHL and am getting a stem cell transplant or CAR T-cell therapy.
I meet the FDA requirements for my specific CAR T cell therapy.
I am 18 years old or older.
I am fully active or can carry out light work.
My PET/CT scan shows active cancer before starting CAR T-cell therapy.
I am in complete remission and ready for stem cell transplant.
My kidneys are functioning well enough, with a creatinine clearance of 30 mL/min or more.
I have had hepatitis C but my viral load is now undetectable.
Exclusion Criteria
I have an autoimmune disease treated with medication in the last 2 years.
I have an immune system disorder or I'm on long-term steroids.
I have a known history of HIV.
I have had myeloid malignancies or T-cell lymphoblastic lymphoma before.
I cannot take pills by mouth or have a condition that affects how my body absorbs nutrients.
I have not had radiotherapy in the last 14 days.
I have previously been treated with EZH2 inhibitors or similar drugs.
I have a history of chronic hepatitis B.
I have or had lung inflammation that needed steroids.
I have another cancer that is getting worse or I am currently being treated for.
I am not pregnant or nursing.
I have active brain metastases or carcinomatous meningitis.
I have side effects from previous cancer treatments that affect my health.
I have received an organ or tissue transplant from another person.
Treatment Details
The trial is testing the combination of pembrolizumab (a monoclonal antibody that helps the immune system detect and fight cancer cells) and tazemetostat (a drug that may stop cancer growth by blocking certain enzymes), to see if they can improve outcomes in patients post-ASCT or CAR-T therapy.
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, tazemetostat)Experimental Treatment6 Interventions
Starting on day 14 after standard of care ASCT or CAR-T cell treatment patients receive pembrolizumab IV on day 1 of each cycle. Starting cycle 2, patients receive tazemetostat PO BID on days 1-21 of each cycle. Cycles repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography during screening, CT scan, PET scan, and blood sample collection throughout the study.
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
🇺🇸 Approved in United States as KEYTRUDA for:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
🇪🇺 Approved in European Union as KEYTRUDA for:
- Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Urothelial carcinoma
- Colorectal cancer
- Gastric cancer
- Hepatocellular carcinoma
- Renal cell carcinoma
- Cervical cancer
- Endometrial carcinoma
🇬🇧 Approved in United Kingdom as KEYTRUDA for:
- Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
Find a clinic near you
Research locations nearbySelect from list below to view details:
Northwestern UniversityChicago, IL
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Certolizumab pegol. [2022]Certolizumab pegol (Cimzia(®)) is currently the only PEGylated anti-TNFα biologic approved for the treatment of rheumatoid arthritis and Crohn disease. The product, developed by UCB, is a humanized antigen-binding fragment (Fab') of a monoclonal antibody that has been conjugated to polyethylene glycol. Certolizumab pegol was approved as a treatment for rheumatoid arthritis in the EU, US and Canada in 2009, and as a treatment for Crohn disease in Switzerland in 2007 and the US in 2008. Certolizumab pegol is entering into an increasingly competitive marketplace, especially in rheumatoid arthritis, but clinical data demonstrate benefits across a range of clinical, radiographic and patient reported outcomes.
Pembrolizumab: first global approval. [2021]Pembrolizumab [Keytruda(®) (US)], a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein, has been developed by Merck & Co for the treatment of cancer. Pembrolizumab has received its first global approval for the treatment of advanced, unresectable or metastatic malignant melanoma in the US, for use in patients with disease progression after prior treatment with ipilimumab and, for BRAF V600 mutation-positive patients, a BRAF inhibitor. It is the first anti-PD-1 therapy to receive regulatory approval in the US, and is currently under regulatory review in the EU. This article summarizes the milestones in the development of pembrolizumab leading to this first approval for the treatment of malignant melanoma.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]New insights into the interaction between the immune system and the tumor microenvironment have led to the development of checkpoint inhibitors that target the PD-1/PD-L1 pathway. Pembrolizumab (MK-3475, lambrolizumab, Keytruda(®)) is a PD-1 inhibitor that has shown clinical activity in a variety of solid tumors and is currently approved for the second-line treatment of PD-L1-positive non-small-cell lung cancer and for unresectable/metastatic melanoma. This article will discuss the results of early-phase trials of pembrolizumab in thoracic malignancies as well as ongoing studies aimed to confirm clinical benefit.
Efficacy and safety of methotrexate plus certolizumab pegol or placebo in active rheumatoid arthritis : Meta-analysis of randomized controlled trials. [2019]This study aimed to assess the relative efficacy and safety of certolizumab pegol (CZP) 200 and 400 mg + methotrexate (MTX) compared to placebo + MTX in patients with active rheumatoid arthritis (RA).
Certolizumab Pegol: A Review in Inflammatory Autoimmune Diseases. [2017]Certolizumab pegol (Cimzia®) is a subcutaneously administered polyethylene glycolylated (PEGylated) antigen-binding fragment of a recombinant human monoclonal antibody that selectively neutralizes TNFα. The drug is indicated for a variety of inflammatory autoimmune diseases, including Crohn's disease (CD), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), based on its benefit in these settings in well-designed clinical trials. In these studies, certolizumab pegol (as first- or subsequent-line therapy) reduced the severity of CD when used as an induction or maintenance therapy, and improved the signs/symptoms and slowed the radiographic progression of RA (with or without concomitant methotrexate), PsA and axSpA. Certolizumab pegol is generally well tolerated, with upper respiratory tract infections, rash and urinary tract infections being among the most frequent adverse reactions. Thus, certolizumab pegol is an effective option for the management of these autoimmune diseases.
Programmed Cell Death-1 Inhibitor-Induced Type 1 Diabetes Mellitus. [2022]Pembrolizumab (Keytruda; Merck Sharp & Dohme) is a humanized IgG4 monoclonal antibody used in cancer immunotherapy. It targets the programmed cell death-1 (PD-1) receptor, which is important in maintaining self-tolerance. However, immune checkpoint blockade is associated with a risk for immune-related adverse events (irAEs) potentially affecting the endocrine organs. Type 1 diabetes mellitus is a rare irAE of PD-1 inhibitors, occurring in 0.2% of cases.
Multiple autoimmune side effects of immune checkpoint inhibitors in a patient with metastatic melanoma receiving pembrolizumab. [2021]Immune agents including anti-programmed death receptor-1 and anti-cytotoxic T-lymphocyte antigen-4 have been associated with numerous immune-related complications. Pembrolizumab, a programmed death-1 inhibitor, has been associated with a number of immune-related adverse events such as pneumonitis, colitis, hepatitis, hypophysitis, hyperthyroidism, hypothyroidism, nephritis, and type 1 diabetes.
Long-term efficacy of certolizumab pegol for the treatment of plaque psoriasis: 3-year results from two randomized phase III trials (CIMPASI-1 and CIMPASI-2). [2021]Certolizumab pegol (CZP) is an Fc-free, PEGylated anti-tumour necrosis factor biologic.
DESTINATION: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the long-term safety and tolerability of tezepelumab in adults and adolescents with severe, uncontrolled asthma. [2021]Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. The efficacy, safety and oral corticosteroid-sparing potential of tezepelumab are being investigated in two ongoing, phase 3, randomized, double-blind, placebo-controlled studies (NAVIGATOR [NCT03347279] and SOURCE [NCT03406078]). DESTINATION (NCT03706079) is a long-term extension (LTE) of these studies.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]A phase II trial investigating the therapeutic effect of neoadjuvant programmed cell death 1 (PD-1) inhibitor pembrolizumab (MK-3475, KEYTRUDA®) administered prior to surgery for the treatment of non-small cell lung cancer (NSCLC) has been conducted (NCT03197467). We report the first clinical results of a planned interim safety analysis after 15 patients were enrolled.
New Approved Use for Keytruda. [2022]Pembrolizumab (Keytruda) is now approved as a single agent to treat advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient in those whose disease has progressed following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.