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NCT05008224CompletedPhase 2

Study of Safety and Efficacy of Pembrolizumab and Chemotherapy in Participants With Newly Diagnosed Classical Hodgkin Lymphoma (cHL) (MK-3475-C11/KEYNOTE-C11)

Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

Source: ClinicalTrials.gov · Last updated 6 Jun 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) monotherapy, followed by chemotherapy, followed by pembrolizumab consolidation. The primary hypothesis of the study is that the complete response (CR) rate at the end of study intervention according to Lugano 2014 response criteria is higher than conventional chemotherapy.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
146 (actual)
First submitted
13 Aug 2021
Start date
7 Oct 2021
Primary completion date
11 Oct 2023
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05008224
EU CT number
2022-501615-14-00
EudraCT number
2021-001244-95

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 146
  • From 7 Oct 2021 to the primary completion date, 11 Oct 2023
  • 46 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

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 prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Has received or is expected to receive 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 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 medication
  • Has had an allogenic tissue/solid organ transplant

Other illness

  • Has an uncontrolled intercurrent cardiovascular illness
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Lab values

  • Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)

Other

  • The main exclusion criteria include, but are not limited to the following:
  • Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
  • Has a history or current evidence of pulmonary fibrosis

Who the study is looking for

  • The main inclusion criteria include, but are not limited to the following:
  • Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
  • Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
  • Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention

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

Full criteria on ClinicalTrials.gov

Sites (46)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mater Misericordiae Limited ( Site 0904)
Coordinator of this site? Confirm its status
BrisbaneAustraliaUnknown status
Monash Health-Haematology Research ( Site 0908)
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Liverpool Hospital-Haematology ( Site 0906)
Coordinator of this site? Confirm its status
LiverpoolAustraliaUnknown status
Peter MacCallum Cancer Centre ( Site 0905)
Coordinator of this site? Confirm its status
MelbourneAustraliaUnknown status
Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907)
Coordinator of this site? Confirm its status
WoolloongabbaAustraliaUnknown status
Cross Cancer Institute ( Site 0207)
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0205)
Coordinator of this site? Confirm its status
Greenfield ParkCanadaUnknown status
Jewish General Hospital ( Site 0200)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Hopital du Sacre-Coeur de Montreal ( Site 0206)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
McGill University Health Centre ( Site 0209)
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Instituto Nacional del Cancer ( Site 1205)
Coordinator of this site? Confirm its status
ChileChileUnknown status
Clínica Alemana de Santiago ( Site 1206)
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
FALP-UIDO ( Site 1202)
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1204)
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
Centro Investigación del Cáncer James Lind ( Site 1200)
Coordinator of this site? Confirm its status
TemucoChileUnknown status
Institut Catala D'oncologia
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario 12 de Octubre
Coordinator of this site? Confirm its status
MadridSpainCompleted
Centre Hospitalier Universitaire de Dijon
Coordinator of this site? Confirm its status
DijonFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
Coordinator of this site? Confirm its status
PessacFranceCompleted
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
Pierre-BéniteFranceCompleted
Centre Hospitalier Universitaire de Rennes
Coordinator of this site? Confirm its status
RennesFranceCompleted
Centre Henri Becquerel
Coordinator of this site? Confirm its status
RouenFranceCompleted
Bnai Zion Medical Center-Hematology ( Site 1909)
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Rambam Health Care Campus ( Site 1907)
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Hadassah Medical Center ( Site 1901)
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Sheba Medical Center-Hemato Oncology ( Site 1904)
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
ZIV Medical Center ( Site 1908)
Coordinator of this site? Confirm its status
SafedIsraelUnknown status
Sourasky Medical Center ( Site 1905)
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Coordinator of this site? Confirm its status
BolognaItalyCompleted
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyCompleted
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyCompleted
Uniwersyteckie Centrum Kliniczne
Coordinator of this site? Confirm its status
GdanskPolandCompleted
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Moscow City Clinical Hospital S.P. Botkin ( Site 0702)
Coordinator of this site? Confirm its status
MoscowRussiaUnknown status
First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Almazov National Medical Research Centre ( Site 0704)
Coordinator of this site? Confirm its status
Saint PetersburgRussiaUnknown status
Northwestern Memorial Hospital ( Site 0002)
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
St Joseph Heritage Healthcare-Oncology ( Site 0004)
Coordinator of this site? Confirm its status
FullertonUnited StatesUnknown status
University of Tennessee Medical Center-Cancer Institute ( Site 0006)
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesUnknown status
OptumCare Cancer Care-Research Department ( Site 0005)
Coordinator of this site? Confirm its status
Las VegasUnited StatesUnknown status
Stanford Cancer Center ( Site 0023)
Coordinator of this site? Confirm its status
Palo AltoUnited StatesUnknown status
Texas Oncology-Plano East ( Site 0020)
Coordinator of this site? Confirm its status
PlanoUnited StatesUnknown status
Ankara University Hospital Cebeci-hematology ( Site 5000)
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Unknown status
Dokuz Eylül Üniversitesi ( Site 5002)
Coordinator of this site? Confirm its status
BalçovaTurkey (Türkiye)Unknown status
Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001)
Coordinator of this site? Confirm its status
IstanbulTurkey (Türkiye)Unknown status

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