A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of MK-7684A (MK-7684 [Vibostolimab] With MK-3475 [Pembrolizumab] Coformulation) in Participants With Relapsed or Refractory Hematological Malignancies

  • STATUS
    Recruiting
  • End date
    Sep 9, 2024
  • participants needed
    180
  • sponsor
    Merck Sharp & Dohme LLC
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Updated on 23 October 2022
See if I qualify
lymphoma
multiple myeloma
measurable disease
kinase inhibitor
hepatitis b surface antigen
mantle cell lymphoma

Summary

The purpose of the study is to determine the safety and tolerability of pembrolizumab/vibostolimab (MK-7684A) in hematological malignancies. This study will also evaluate the overall response rate (ORR), the duration of response (DOR), and disease control rate (DCR) following administration of pembrolizumab/vibostolimab. In addition, this study will characterize pharmacokinetic (PK) profile of vibostolimab (MK-7684).

Details
Condition Hematological Malignancies
Treatment Pembrolizumab/Vibostolimab coformuation
Clinical Study IdentifierNCT05005442
SponsorMerck Sharp & Dohme LLC
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Have confirmed relapsed/refractory classic Hodgkins Lyphoma (cHL), Primary mediastinal B-cell lymphoma (PMBCL), Follicular Lymphoma (FL), Diffuse large B-cell lymphoma (DLBCL) or Non-Hodgkins Lymphoma (NHL), or multiple myeloma (MM)
For PMBCL, DLBCL, FL, and MM
Must be relapsed or refractory to CAR-T-cell therapy or unable to receive it
For DLBCL and NHL
Must have exhausted or be ineligible for or intolerant to all treatments, which in the opinion of the investigator are standard of care for their disease
For NHL
Participants with Mantle cell lymphoma (MCL) must have received prior Bruton's tyrosine kinase inhibitor therapy
All participants
Have measurable disease
Have adequate organ function
Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
Must be able to provide newly obtained bone marrow biopsy or aspirate material for disease assessment
Female participants are eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of non child-bearing potential (WONCBP) OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle

Exclusion Criteria

For DLBCL and NHL
Has lymphoplasmacytic lymphomas, Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (not associated with small lymphocytic lymphoma), Burkitt (-like) lymphoma, mature T cell and NK cell neoplasms, immunodeficiency associated lymphoproliferative neoplasms, or histiocytic and dendritic cell neoplasms
For MM
Has oligo-secretory myeloma, plasma cell leukemia, smoldering multiple myeloma, or monoclonal gammopathy of undetermined significance
Has a history of primary amyloidosis, hyperviscosity or POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
Has known prior or current central nervous system (CNS) involvement
For Epstein Barr virus (EBV) positive DLBCL
Associated with a solid organ transplant
For all participants
A WOCBP who has a positive urine pregnancy test within 72 hours before study intervention allocation
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
Has a history of a second malignancy
Any PMBCL participants that require the use of urgent cytoreductive therapy
If the participant had major surgery, the participant must have recovered adequately from the procedure and/or any complications from the surgery before starting study intervention
Has received prior radiotherapy within 2 weeks of start of study intervention
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
Has a known severe hypersensitivity to MK-7684A, vibostolimab or pembrolizumab and/or any of its excipients
Has a known history of Human Immunodeficiency Virus (HIV) infection
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has an active infection requiring systemic therapy
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has present or progressive accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks before enrollment
Has dual active HBV infection (HBsAg (+) and /or detectable HBV DNA) and Hepatitis C (HCV) infection (anti-HCV Ab (+) and detectable HCV RNA) at study entry
Has had an allogenic hematopoietic stem cell/solid organ transplantation within the last 5 years
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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