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| ID | Type | Description | Link |
|---|---|---|---|
| MK-4280A-008 | Other Identifier | MSD | |
| 2023-503615-14-00 | Registry Identifier | EU CT | |
| U1111-1287-5864 | Registry Identifier | UTN | |
| 2022-000371-39 | EudraCT Number |
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Researchers are looking for a way to treat classical Hodgkin lymphoma (cHL) that is relapsed (the cancer has come back after treatment) or refractory (current treatment has stopped working to slow or stop cancer growth). Researchers want to learn if people who receive coformulated favezelimab/pembrolizumab (MK-4280A) live longer without the cancer getting worse compared to those who receive chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favezelimab/Pembrolizumab | Experimental | Participants will receive coformulated favezelimab/pembrolizumab (800 mg/200 mg) by intravenous (IV) infusion on Day 1, then every three weeks (Q3W), for up to 35 infusions. |
|
| Chemotherapy (Bendamustine or Gemcitabine) | Active Comparator | Participants will receive physician's choice of EITHER bendamustine by IV infusion at a dose between 90 and 120 mg/m^2 on Day 1 and Day 2 of either a 3- or 4-week cycle for up to 6 cycles OR gemcitabine by IV infusion at a dose between 800 and 1200 mg/m^2 on Day 1 and Day 8 of a 3-week cycle for up to 6 cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| favezelimab/pembrolizumab | Biological | Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) per Lugano Response Criteria as Assessed by investigator | PFS is defined as the time from randomization to the first documented disease progression per Lugano criteria 2014 as assessed by investigator or death due to any cause, whichever occurs first. | Up to approximately 39 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 39 months |
| Objective Response Rate (ORR) per Lugano Response Criteria as Assessed by investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona Cancer Center - North Campus ( Site 2216) | Tucson | Arizona | 85719 | United States | ||
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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| bendamustine | Drug | IV infusion |
|
|
| gemcitabine | Drug | IV infusion |
|
|
ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR) per Lugano criteria 2014 as assessed by investigator.
| Up to approximately 39 months |
| Duration of Response (DOR) per Lugano Response Criteria as Assessed by investigator | For participants who demonstrate CR or PR per Lugano criteria 2014 as assessed by investigator, DOR is defined as the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurs first. | Up to approximately 39 months |
| Number of Participants Who Experienced At Least One Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented. | Up to approximately 25 months |
| Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented. | Up to approximately 24 months |
| UCLA Hematology/Oncology - Santa Monica ( Site 2208) |
| Los Angeles |
| California |
| 90404 |
| United States |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA-Hematology and Medical Oncology ( Site | Torrance | California | 90502 | United States |
| Moffitt Cancer Center ( Site 2200) | Tampa | Florida | 33612 | United States |
| University of Kentucky Chandler Medical Center ( Site 2201) | Lexington | Kentucky | 40536 | United States |
| University of Maryland-Greenebaum Comprehensive Cancer Center ( Site 2210) | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins University-The Sidney Kimmel Comprehensive Cancer Center ( Site 2206) | Baltimore | Maryland | 21231 | United States |
| University of Michigan ( Site 2215) | Ann Arbor | Michigan | 48109 | United States |
| Cancer and Hematology Centers of Western Michigan ( Site 2222) | Grand Rapids | Michigan | 49503 | United States |
| Rutgers Cancer Institute of New Jersey ( Site 2217) | New Brunswick | New Jersey | 08903 | United States |
| Roswell Park Cancer Institute ( Site 2220) | Buffalo | New York | 14263 | United States |
| University Hospitals Cleveland Medical Center ( Site 2214) | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic-Taussig Cancer Center ( Site 2203) | Cleveland | Ohio | 44195 | United States |
| AHN West Penn Hospital ( Site 2213) | Pittsburgh | Pennsylvania | 15224 | United States |
| UPMC Hillman Cancer Center ( Site 2205) | Pittsburgh | Pennsylvania | 15232 | United States |
| Fred Hutchinson Cancer Center ( Site 2212) | Seattle | Washington | 98109 | United States |
| Hospital Aleman-oncohematologic diseases ( Site 2302) | Buenos Aires | C1118AAT | Argentina |
| Fundacion Centro Oncologico de Integración Regional-Medical Oncology ( Site 2301) | Mendoza | M5500AYB | Argentina |
| The Townsville Hospital ( Site 0006) | Townsville | Queensland | 4814 | Australia |
| Royal Adelaide Hospital ( Site 0005) | Adelaide | South Australia | 5000 | Australia |
| Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 0002) | St Albans | Victoria | 3021 | Australia |
| Royal Perth Hospital-Haematology ( Site 0004) | Perth | Western Australia | 6000 | Australia |
| UZ Leuven-Hematology ( Site 0101) | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi | Namur | 5530 | Belgium |
| Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0202) | Barretos | São Paulo | 14784400 | Brazil |
| Hospital Paulistano-Americas Oncologia ( Site 0207) | São Paulo | 01321-001 | Brazil |
| Cross Cancer Institute ( Site 0313) | Edmonton | Alberta | T6G 1Z2 | Canada |
| Princess Margaret Cancer Centre ( Site 0310) | Toronto | Ontario | M5G 2M9 | Canada |
| Jewish General Hospital ( Site 0309) | Montreal | Quebec | H3T 1E2 | Canada |
| McGill University Health Centre ( Site 0314) | Montreal | Quebec | H4A 3J1 | Canada |
| FALP-UIDO ( Site 0400) | Santiago | Region M. de Santiago | 7500921 | Chile |
| Clínica Inmunocel ( Site 0407) | Santiago | Region M. de Santiago | 7580206 | Chile |
| Anhui Provincial Cancer Hospital ( Site 0501) | Hefei | Anhui | 230031 | China |
| Beijing Hospital ( Site 0514) | Beijing | Beijing Municipality | 100005 | China |
| Peking University Third Hospital-Hematology ( Site 0519) | Beijing | Beijing Municipality | 100091 | China |
| The First Affiliated hospital of Xiamen University ( Site 0512) | Xiamen | Fujian | 361003 | China |
| Sun Yat-sen University Cancer Center ( Site 0500) | Guangzhou | Guangdong | 510060 | China |
| Henan Cancer Hospital ( Site 0515) | Zhengzhou | Henan | 450008 | China |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0509) | Wuhan | Hubei | 430010 | China |
| Xiangya Hospital Central South University ( Site 0513) | Changsha | Hunan | 410008 | China |
| Hunan Cancer Hospital ( Site 0503) | Changsha | Hunan | 410013 | China |
| The First Hospital of Jilin University-Hematology ( Site 0516) | Changchun | Jilin | 130021 | China |
| Fudan University Shanghai Cancer Center ( Site 0520) | Shanghai | Shanghai Municipality | 200032 | China |
| West China Hospital of Sichuan University-Head and Neck Oncology ( Site 0502) | Chengdu | Sichuan | 610041 | China |
| Tianjin Medical University Cancer Institute & Hospital-lymphoma ( Site 0506) | Tianjin | Tianjin Municipality | 300060 | China |
| Zhejiang Cancer Hospital ( Site 0510) | Hangzhou | Zhejiang | 310022 | China |
| Ningbo First Hospital ( Site 0518) | Ningbo | Zhejiang | 315010 | China |
| Fakultní nemocnice Brno Bohunice-Interni hematologicka a onkologicka klinika ( Site 0901) | Brno | Brno-mesto | 625 00 | Czechia |
| Fakultni nemocnice Hradec Kralove-IV. interni hematologicka klinika ( Site 0902) | Hradec Králové | 500 05 | Czechia |
| Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0903) | Prague | 128 08 | Czechia |
| Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou-haematology ( Site 0707) | Rennes | Brittany Region | 35033 | France |
| Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE ( Site 0706) | Toulouse | Haute-Garonne | 31059 | France |
| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 0704) | Limoges | Haute-Vienne | 87042 | France |
| Institut Curie - site Saint-Cloud ( Site 0708) | Saint-Cloud | Hauts-de-Seine | 92210 | France |
| CENTRE LEON BERARD-Medical oncology ( Site 0703) | Lyon | Rhone | 69008 | France |
| HENRI MONDOR HOSPITAL ( Site 0702) | Créteil | Seine-et-Marne | 94000 | France |
| Klinikum Stuttgart - Katharinenhospital ( Site 0804) | Stuttgart | Baden-Wurttemberg | 70174 | Germany |
| Universitaetsklinikum Ulm-Department of Internal Medicine III ( Site 0805) | Ulm | Baden-Wurttemberg | 89081 | Germany |
| Universitaetsklinikum Koeln-Klinik I für Innere Medizin ( Site 0801) | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Universitaetsklinikum Essen ( Site 0807) | Essen | North Rhine-Westphalia | 45147 | Germany |
| Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 0806) | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitaetsklinikum Carl Gustav Carus Dresden-University Cancer Center Early Clinical Trial Unit ( | Dresden | Saxony | 01307 | Germany |
| Universitätsklinikum Leipzig ( Site 0803) | Leipzig | Saxony | 04103 | Germany |
| Rambam Health Care Campus ( Site 1004) | Haifa | 3109601 | Israel |
| Carmel Hospital ( Site 1007) | Haifa | 3436212 | Israel |
| Hadassah Medical Center-Hemato-Oncology ( Site 1000) | Jerusalem | 9112001 | Israel |
| Rabin Medical Center-Hemato-Oncology ( Site 1001) | Petah Tikva | 4910021 | Israel |
| Sheba Medical Center-Hemato Oncology ( Site 1005) | Ramat Gan | 5265601 | Israel |
| Sourasky Medical Center ( Site 1002) | Tel Aviv | 6423906 | Israel |
| Centro de Infusion Superare ( Site 2503) | Mexico City | Mexico City | 03100 | Mexico |
| Unidad Médica Onco-hematológica ( Site 2507) | Puebla City | 72424 | Mexico |
| Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1406) | Krakow | Lesser Poland Voivodeship | 31-826 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Hematologii, Nowotworów Krwi i | Wroclaw | Lower Silesian Voivodeship | 50-556 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Kilinka Onkologii I Hematologii ( Site | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Uniwersyteckie Centrum Kliniczne-Klinika Hematologii i Transplantologii ( Site 1402) | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| Swietokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakl-Klinika Hematologii i Transplantacji S | Kielce | Świętokrzyskie Voivodeship | 25-734 | Poland |
| Pusan National University Hospital-Internal Medicine ( Site 1704) | Busan | Pusan-Kwangyokshi | 49241 | South Korea |
| Seoul National University Hospital ( Site 1701) | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1702) | Seoul | 03722 | South Korea |
| Asan Medical Center-Department of Oncology ( Site 1703) | Seoul | 05505 | South Korea |
| Samsung Medical Center ( Site 1700) | Seoul | 06351 | South Korea |
| Hospital Universitario Marqués de Valdecilla ( Site 1805) | Santander | Cantabria | 39008 | Spain |
| Hospital Universitari Vall d'Hebron ( Site 1803) | Barcelona | Catalonia | 08035 | Spain |
| CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 1812) | A Coruña | La Coruna | 15006 | Spain |
| Hospital Insular de Gran Canaria-Oncology ( Site 1807) | Las Palmas de Gran Canaria | Las Palmas | 35016 | Spain |
| Hospital General Universitario de Alicante ( Site 1806) | Alicante | 03010 | Spain |
| Hospital Universitario 12 de Octubre-Hemathology and hemotherapy ( Site 1810) | Madrid | 28041 | Spain |
| Hospital Universitario Virgen de la Victoria ( Site 1808) | Málaga | 29010 | Spain |
| Hospital Universitario de Salamanca - Complejo Asistencial U-Servicio de Hematologia ( Site 1801) | Salamanca | 37007 | Spain |
| Skånes Universitetssjukhus Lund ( Site 1901) | Lund | Skåne County | 22185 | Sweden |
| Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 1900) | Uppsala | Uppsala County | 751 85 | Sweden |
| Ospedale Regionale Bellinzona e Valli-IOSI ( Site 1600) | Bellinzona | Canton Ticino | 6501 | Switzerland |
| Mega Medipol-Hematology ( Site 2005) | Stanbul | Istanbul | 34214 | Turkey (Türkiye) |
| Ankara Universitesi Tip Fakultesi Hastanesi-hematology ( Site 2000) | Ankara | 06100 | Turkey (Türkiye) |
| Hacettepe Universite Hastaneleri-Department of Hematology ( Site 2006) | Ankara | 06230 | Turkey (Türkiye) |
| Antalya Egitim ve Arastırma Hastanesi ( Site 2011) | Antalya | 07100 | Turkey (Türkiye) |
| Ege Universitesi Hastanesi ( Site 2001) | Izmir | 35100 | Turkey (Türkiye) |
| Kocaeli Üniversitesi-Hematology ( Site 2009) | Kocaeli | 41380 | Turkey (Türkiye) |
| Derriford Hospital ( Site 2107) | Plymouth | Devon | Pl6 8DH | United Kingdom |
| The Beatson West of Scotland Cancer Centre ( Site 2110) | Glasgow | Glasgow City | G12 0YN | United Kingdom |
| St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 2105) | London | London, City of | EC1A 7BE | United Kingdom |
| GenesisCare - Oxford ( Site 2104) | Oxford | Oxfordshire | OX4 6LB | United Kingdom |
| St James's University Hospital ( Site 2109) | Leeds | LS9 7TF | United Kingdom |
| Leicester Royal Infirmary ( Site 2100) | Leicester | LE1 5WW | United Kingdom |
| Clatterbridge Cancer Centre - Liverpool-Heamatology ( Site 2108) | Liverpool | L7 8YA | United Kingdom |
| ID | Term |
|---|---|
| D006689 | Hodgkin Disease |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000069461 | Bendamustine Hydrochloride |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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