Zilovertamab Vedotin for Lymphoma
Recruiting in Palo Alto (17 mi)
+104 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Hepatitis B antivirals
Must not be taking: Corticosteroids, others
Disqualifiers: Organ transplant, Cardiovascular disease, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called zilovertamab vedotin to see if it can help treat certain blood cancers that have not responded to other treatments. The drug works by targeting and killing cancer cells using a combination of an antibody and a drug.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot have received certain cancer therapies or radiotherapy shortly before starting the study. It's best to discuss your current medications with the trial team.
What makes the drug Zilovertamab vedotin unique for treating lymphoma?
Zilovertamab vedotin is unique because it combines an antibody that targets specific cancer cells with a drug that kills those cells, similar to brentuximab vedotin, but it targets a different protein on the cancer cells, potentially offering a new option for patients who do not respond to other treatments.
12345Eligibility Criteria
This trial is for adults with certain B-cell lymphomas (like MCL, RTL, FL, CLL) that have come back or didn't respond after previous treatments. They should be able to perform daily activities with minimal help and not have severe ongoing health issues like infections or heart disease. People who've had recent vaccines, live with HIV/HBV/HCV, or received cancer treatment too close to the study start are excluded.Inclusion Criteria
I have a relapsed or unresponsive aggressive B-cell cancer as confirmed by a biopsy.
I am HBsAg positive but have been on HBV therapy for 4+ weeks with an undetectable viral load.
My B-cell cancer has returned or didn't respond after 2 treatments and no other options are available.
+3 more
Exclusion Criteria
My follicular lymphoma has changed into a more aggressive form.
My lymphoma has spread to my brain or spinal cord.
Has received solid organ transplant at any time.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive zilovertamab vedotin as monotherapy or in combination every 3 weeks until disease progression or discontinuation
Up to approximately 57 months
Every 3 weeks (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4-8 weeks
Participant Groups
The trial tests Zilovertamab vedotin alone and combined with Nemtabrutinib in patients divided into groups based on their specific type of lymphoma and prior treatments. The main goal is to see how well these therapies shrink the cancer as judged by independent reviewers using established criteria.
5Treatment groups
Experimental Treatment
Group I: Cohort E, Relapsed or Refractory FL with 2 Prior Lines of TherapyExperimental Treatment1 Intervention
Participants will receive either zilovertamab vedotin IV infuison Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Group II: Cohort D, Relapsed or Refractory FL and CLL with 2 Prior Lines of TherapyExperimental Treatment1 Intervention
Participants will receive either zilovertamab vedotin IV infusion Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Group III: Cohort C, Relapsed or Refractory MCL with 1 Prior Line of TherapyExperimental Treatment2 Interventions
Participants will receive zilovertamab vedotin IV infusion at Dose 2 every 3 weeks (Q3W) combined with nemtabrutinib oral dose daily until disease progression or discontinuation.
Group IV: Cohort B, Relapsed or Refractory RT with 1 Prior Line of TherapyExperimental Treatment1 Intervention
Participants will receive zilovertamab vedotin IV infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Group V: Cohort A, Relapsed or Refractory MCL with 2 Prior Lines of TherapyExperimental Treatment1 Intervention
Participants will receive zilovertamab vedotin intravenous (IV) infusion at Dose 1 every 3 weeks (Q3W) until disease progression or discontinuation.
Zilovertamab vedotin is already approved in European Union for the following indications:
🇪🇺 Approved in European Union as Zilovertamab vedotin for:
- Orphan designation for hematological malignancies
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 0200)Toronto, Canada
University of Michigan ( Site 0009)Ann Arbor, MI
Banner MD Anderson Cancer Center ( Site 0040)Gilbert, AZ
University of Colorado Anschutz Medical Campus-The Center for Cancer and Blood Disorders ( Site 0008Aurora, CO
More Trial Locations
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Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLCLead Sponsor
References
Brentuximab vedotin in real life, a seven year experience in patients with refractory/relapsed CD30+ T cell lymphoma. [2021]Brentuximab vedotin (Bv) has been approved for the treatment of Refractory/Relapsed (R/R) Anaplastic Large Cell Lymphomas (ALCL) and cutaneous T-Cell Lymphomas, but is also effective in other CD30+ malignancies. We report here the outcomes of patients with various R/R Peripheral T Cell Lymphoma (PTCL) treated with Bv in real life practice.
Brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma who are Ineligible for autologous stem cell transplant: A Germany and United Kingdom retrospective study. [2019]Brentuximab vedotin (BV) is an anti-CD30 antibody-drug conjugate licensed for the treatment of relapsed/refractory Hodgkin lymphoma (rrHL) following autologous stem cell transplant (ASCT) or at least two prior therapies when ASCT or multiagent chemotherapy is not an option. The objective of this study was to describe real-world outcomes with BV in patients with rrHL considered ASCT ineligible or who refuse ASCT.
Response to Brentuximab Vedotin by CD30 Expression in Non-Hodgkin Lymphoma. [2022]The safety and efficacy of brentuximab vedotin (BV), an antibody-drug conjugate directed to the CD30 antigen, has been assessed in several trials in patients with peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL), or B-cell non-Hodgkin lymphoma (NHL). The objective of this research was to examine the relationship between CD30 expression level and clinical response to BV.
Desensitization to Brentuximab Vedotin after anaphylaxis in refractory Hodgkin's lymphoma. [2023]Brentuximab vedotin (BV) is a monoclonal antibody that targets CD30 antigen. It is indicated for the treatment of CD30 + lymphomas and classical Hodgkin lymphoma (HL), including advanced (stage III-IV) untreated disease, relapsed/refractory disease, and consolidation after autologous hematopoietic stem cell transplantation. In clinical trials the incidence of a hypersensitivity reaction is 1.2%.
New uses for brentuximab vedotin and novel antibody drug conjugates in lymphoma. [2019]Brentuximab vedotin (BV) is a potent anti-CD30 antibody drug conjugate (ADC) that has been approved in relapsed or refractory Hodgkin lymphoma (HL) after autologous stem cell transplantation (ASCT) and anaplastic large-cell lymphoma (ALCL). Beyond these consolidated indications, BV has been tested in a number of different settings with promising results, leading for example to the recent approval as a consolidation after ASCT in high-risk HL patients.