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
- Diseases
- Hodgkin lymphoma
- 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
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mater Misericordiae Limited ( Site 0904) Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Monash Health-Haematology Research ( Site 0908) Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Liverpool Hospital-Haematology ( Site 0906) Coordinator of this site? Confirm its status | Liverpool | Australia | Unknown status |
| Peter MacCallum Cancer Centre ( Site 0905) Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Princess Alexandra Hospital-Division of Cancer Services Trials Unit ( Site 0907) Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Cross Cancer Institute ( Site 0207) Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0205) Coordinator of this site? Confirm its status | Greenfield Park | Canada | Unknown status |
| Jewish General Hospital ( Site 0200) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Hopital du Sacre-Coeur de Montreal ( Site 0206) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Centre ( Site 0209) Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Instituto Nacional del Cancer ( Site 1205) Coordinator of this site? Confirm its status | Chile | Chile | Unknown status |
| Clínica Alemana de Santiago ( Site 1206) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| FALP-UIDO ( Site 1202) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1204) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Centro Investigación del Cáncer James Lind ( Site 1200) Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Completed |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Completed |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Completed |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Completed |
| Centre Henri Becquerel Coordinator of this site? Confirm its status | Rouen | France | Completed |
| Bnai Zion Medical Center-Hematology ( Site 1909) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Rambam Health Care Campus ( Site 1907) Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah Medical Center ( Site 1901) Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Sheba Medical Center-Hemato Oncology ( Site 1904) Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| ZIV Medical Center ( Site 1908) Coordinator of this site? Confirm its status | Safed | Israel | Unknown status |
| Sourasky Medical Center ( Site 1905) Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Completed |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Completed |
| Uniwersyteckie Centrum Kliniczne Coordinator of this site? Confirm its status | Gdansk | Poland | Completed |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Completed |
| Moscow City Clinical Hospital S.P. Botkin ( Site 0702) Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| First Pavlov State Medical University of Saint Petersburg-Raisa Gorbacheva Memorial Institut for Pe Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Almazov National Medical Research Centre ( Site 0704) Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Northwestern Memorial Hospital ( Site 0002) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| St Joseph Heritage Healthcare-Oncology ( Site 0004) Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| University of Tennessee Medical Center-Cancer Institute ( Site 0006) Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| OptumCare Cancer Care-Research Department ( Site 0005) Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Stanford Cancer Center ( Site 0023) Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Texas Oncology-Plano East ( Site 0020) Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Ankara University Hospital Cebeci-hematology ( Site 5000) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Dokuz Eylül Üniversitesi ( Site 5002) Coordinator of this site? Confirm its status | Balçova | Turkey (Türkiye) | Unknown status |
| Vehbi Koc Vakfi - Amerikan Hastanesi ( Site 5001) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.