Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies (MK-4280-003)

  • STATUS
    Recruiting
  • End date
    Nov 5, 2025
  • participants needed
    134
  • sponsor
    Merck Sharp & Dohme Corp.
Updated on 14 September 2020
Investigator
Toll Free Number
Primary Contact
Concord Repatriation & General Hospital ( Site 0203) (3.3 mi away) Contact
+24 other location
cancer
hematologic malignancy
lymphoma
hodgkin's disease
pembrolizumab
diffuse large b-cell lymphoma
b-cell lymphoma
mk-3475
large b-cell lymphoma
classical hodgkin lymphoma

Summary

This study will evaluate the safety and efficacy of MK-4280 in combination with pembrolizumab (MK-3475) in participants with hematological malignancies:

  • classical Hodgkin lymphoma (cHL)
  • diffuse large B-cell lymphoma (DLBCL)
  • indolent non-Hodgkin lymphoma (iNHL) The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The recommended Phase 2 dose (RPTD) will be determined in the safety lead-in phase by evaluating dose-limiting toxicities.

Details
Treatment Pembrolizumab, MK-4280
Clinical Study IdentifierNCT03598608
SponsorMerck Sharp & Dohme Corp.
Last Modified on14 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Lymphoma or Lymphoma, B-Cell or B-Cell Lymphoma or Hodgkin's Disease or Non-Hodgkin's Lymphoma?
Has measureable disease, defined as 1 lesion that can be accurately measured in 2 dimensions with diagnostic quality cross sectional anatomic imaging (computed tomography or magnetic resonance imaging). Minimum measurement must be >15 mm in the longest diameter or >10 mm in the short axis
Is able to provide a core or excisional tumor biopsy for biomarker analysis from an archival (within 3 months) or newly obtained biopsy at screening
Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)

Exclusion Criteria

Has known clinically active central nervous system (CNS) involvement
Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody
Has received chimeric antigen receptors (CAR)-T-cell therapy
Has received prior anticancer therapy or thoracic radiation therapy within 14 days before the first dose of study treatment
Has Grade 2 non-hematological toxicities from prior therapy
Has had a prior anticancer monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e., Grade 1 or at baseline) from AEs due to agents administered 4 weeks earlier
Has received a live vaccine within 30 days prior to first dose of study treatment
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 28 days before study Day 1
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug
Has a known additional malignancy that is progressing or requires active treatment with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy
Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
Has an active infection requiring intravenous systemic therapy
Has a known history of human immunodeficiency virus (HIV) infection
Has known, active hepatitis B or hepatitis C infection
Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment
Has had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years
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