For Healthcare Professionals

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

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About the study

This study will evaluate the safety and efficacy of favezelimab (MK-4280) in combination with pembrolizumab (MK-3475) using a non-randomized study design in participants with the following hematological malignancies: classical Hodgkin lymphoma (cHL) diffuse large B-cell lymphoma (DLBCL) indolent non-Hodgkin lymphoma (iNHL) This study will also evaluate the safety and efficacy of pembrolizumab or favezelimab administered as monotherapy in participants with cHL using a 1:1 randomized study design. The study will have 2 phases: a safety lead-in and an efficacy expansion phase. The recommended Phase 2 dose (RP2D) will be determined in the safety lead-in phase by evaluating dose-limiting toxicities. There is no primary hypothesis for this study.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Has measurable 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
  2. 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
  3. Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Has known clinically active central nervous system (CNS) involvement
  2. Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody
  3. Has received chimeric antigen receptors (CAR)-T-cell therapy for cHL and DLBCL Cohorts
  4. Has received prior anticancer therapy or thoracic radiation therapy within 14 days before the first dose of study treatment
  5. Has ≥Grade 2 non-hematological residual toxicities from prior therapy
  6. 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
  7. Has received a live vaccine within 30 days prior to first dose of study treatment. Administration of killed vaccines are allowed
  8. Has received an investigational agent or used an investigational device within 4 weeks prior to intervention administration
  9. 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
  10. 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
  11. 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)
  12. Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis
  13. Has an active infection requiring intravenous systemic therapy
  14. Has a known history of human immunodeficiency virus (HIV) infection
  15. Has known, active hepatitis B or hepatitis C infection
  16. 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
  17. Has had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Hodgkin Disease,Lymphoma, Non-Hodgkin,Lymphoma, B-Cell

Age (in years)

18+

Phase

Phase 1/Phase 2

Participants needed

174

Est. Completion Date

Oct 19, 2027

Treatment type

Interventional


Sponsor

Merck Sharp & Dohme LLC

ClinicalTrials.gov identifier

NCT03598608

Study number

MK4280-003

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