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NCT03598608TerminatedPhase 1/2

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)

A Phase 1/Phase 2 Clinical Study to Evaluate the Safety and Efficacy of a Combination of MK-4280 and Pembrolizumab (MK-3475) in Participants With Hematologic Malignancies

Source: ClinicalTrials.gov · Last updated 28 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
137 (actual)
First submitted
16 Jul 2018
Start date
17 Oct 2018
Primary completion date
28 Jan 2026
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT03598608
EU CT number
2023-503587-17-00
EudraCT number
2018-001461-16

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Has received chimeric antigen receptors (CAR)-T-cell therapy for cHL and DLBCL Cohorts
  • Has received prior anticancer therapy or thoracic radiation therapy within 14 days before the first dose of study treatment
  • Has ≥Grade 2 non-hematological residual 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. Administration of killed vaccines are allowed
  • Has received an investigational agent or used an investigational device within 4 weeks prior to intervention administration
  • 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 had an allogeneic hematopoetic stem cell/solid organ transplantation within the last 5 years

Other illness

  • 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

Lab values

  • Has received prior therapy with an anti-lymphocyte activation gene-3 (LAG-3) antibody

Other

  • Has known clinically active central nervous system (CNS) involvement
  • 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

Who the study is looking for

  • 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
  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Monash Health (Site 0201)
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ClaytonAustraliaUnknown status
Concord Repatriation & General Hospital (Site 0203)
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ConcordAustraliaUnknown status
St Vincent s Hospital (Melbourne) Limited (Site 0202)
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FitzroyAustraliaUnknown status
Princess Alexandra Hospital (Site 0204)
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WoollongabbaAustraliaUnknown status
Jewish General Hospital (Site 0105)
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MontrealCanadaUnknown status
Princess Margaret Cancer Centre (Site 0100)
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TorontoCanadaUnknown status
BC Cancer (Site 0107)
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VancouverCanadaUnknown status
CancerCare Manitoba (Site 0101)
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WinnipegCanadaUnknown status
U. klinikum Koeln AOER (Site 0326)
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CologneGermanyUnknown status
Universitaetsklinikum Leipzig AOeR (Site 0327)
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LeipzigGermanyUnknown status
Rambam Medical Center (Site 0382)
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HaifaIsraelUnknown status
Hadassah Ein Karem Jerusalem (Site 0383)
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JerusalemIsraelUnknown status
Chaim Sheba Medical Center. (Site 0380)
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Ramat GanIsraelUnknown status
Sourasky Medical Center (Site 0381)
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Tel AvivIsraelUnknown status
A.O. Universitaria Policlinico S. Orsola-Malpighi (Site 0351)
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BolognaItalyUnknown status
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (Site 0354)
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MeldolaItalyUnknown status
Humanitas-U.O di Oncologia medica ed Ematologia (Site 0352)
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RozzanoItalyUnknown status
Texas Oncology-Austin Midtown (Site 8002)
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AustinUnited StatesUnknown status
Dana Farber Cancer Institute (Site 0002)
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BostonUnited StatesUnknown status
City of Hope (Site 0001)
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DuarteUnited StatesUnknown status
Banner MD Anderson Cancer Center (Site 0020)
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GilbertUnited StatesUnknown status
Ronald Reagan UCLA Medical Center (Radiological Sciences) (Site 0007)
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Los AngelesUnited StatesUnknown status
Pacific Cancer Care (Site 0006)
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MontereyUnited StatesUnknown status
Fox Chase Cancer Center (Site 0019)
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PhiladelphiaUnited StatesUnknown status
University of California San Francisco (Site 0023)
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San FranciscoUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.