A Phase 3 Trial of Epcoritamab vs Investigator's Choice Chemotherapy in R/R DLBCL

Phase 3

Active, not recruiting

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: Investigator's Choice Chemotherapy; Biological: Epcoritamab

• Registration Number: NCT04628494
• Lead Sponsor: Genmab

Brief Summary

The purpose of this trial is to find out if epcoritamab, also known as EPKINLY™ and GEN3013, is safe and works well as treatment for patients with diffuse large B-cell lymphoma (DLBCL) that are not responding to treatment, have grown in size, or have come back following treatment with at least 1 prior systemic cancer therapy. All participants in this trial w...

Detailed Description

The trial is an open label, multi-center, global phase-3 randomized trial of epcoritamab. The goal of this randomized trial is to evaluate the efficacy of epcoritamab (GEN3013, DuoBody®-CD3xCD20) compared to investigator's choice of chemotherapy, in patients with relapsed, refractory DLBCL who have failed or are ineligible for high-dose chemotherapy and auto...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-13
• Study Start: 2021-01-13
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-05
• Primary Completion: 2024-12
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 552

Inclusion Criteria

1. Relapsed or refractory disease and previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since lymphoma diagnosis

2. One of the confirmed histologies below with CD20-positivity:

   1. DLBCL, NOS, including de novo or histologically transformed from FL
   2. "Double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL
   3. FL Grade 3B
   4. T-cell/histiocyte-rich large B-cell lymphoma

3. ECOG PS score of 0-2

4. Failed previous HDT-ASCT or not eligible for HDT-ASCT at screening

5. Patients must have detectable disease by PET scan and measurable by CT scan or MRI

6. Acceptable renal and liver function

7. Life expectancy >2 months on SOC treatment

Main

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Exclusion Criteria

1. Primary Central Nervous System (CNS) tumor or known CNS involvement
2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
3. Major surgery within 4 weeks prior to randomization
4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
6. ASCT within 100 days of randomization
7. Treatment with CAR-T therapy within 100 days prior to randomization
8. Seizure disorder requiring anti-epileptic therapy
9. Clinically significant cardiac disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigator's choice of chemotherapy	Investigator's Choice Chemotherapy	R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met
Epcoritamab (GEN3013; DuoBody®CD3xCD20)	Epcoritamab	Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	throughout the study and up to 5 years following the last patient first dose	OS is calculated as the time from first dose to death date or last date known to be alive.

Secondary Outcome Measures

Name	Time	Method
Complete Response (CR)	throughout the study and up to 5 years following the last patient first dose	CR rate is calculated as the proportion of subjects achieving a complete response. Response is determined by the Lugano criteria and LYRIC.
Duration of Response (DOR)	throughout the study and up to 5 years following the last patient first dose	DOR is calculated as the time from initial response (CR or PR) to date of progression or death, whichever is earlier. Response and progression are determined by the Lugano criteria and LYRIC.
Time to Response (TTR)	throughout the study and up to 5 years following the last patient first dose	TTR is calculated as the time from randomization to date of initial response (CR or PR) among responders only. Response is determined by the Lugano criteria and LYRIC.
Progression Free Survival (PFS)	throughout the study and up to 5 years following the last patient first dose	PFS is calculated as the time from randomization to the date of disease progression or death, whichever is earlier. Progression is determined by the Lugano criteria and LYRIC.
Incidence and severity of adverse events (AEs)	throughout the study and up to 5 years following the last patient first dose	identify patterns of incidence in adverse events, with particular emphasis on pre-defined adverse events of special interest
Anti-epcoritamab antibody response	throughout the study and up to 5 years following the last patient first dose	calculate incidence of antibody response to epcoritamab in relation to dosing
Incidence and severity of changes in laboratory values	throughout the study and up to 5 years following the last patient first dose	Clinical laboratory parameters assessed: hematology, chemistry, coagulation, tumor lysis, immunoglobulins, and urinalyses
Incidence of dose interruptions and delays	throughout the study and up to 5 years following the last patient first dose	calculate incidence and present the occurrence of dose modifying toxicities by cycles and overall
Overall Response Rate (ORR)	throughout the study and up to 5 years following the last patient first dose	ORR is calculated as the proportion of subjects achieving a complete response or partial response. Response is determined by the Lugano criteria and LYRIC.
Rate and duration of minimal residual disease (MRD) negative status	up to 5 years after randomization of the last patient	Compare other measures of efficacy to SOC - MRD negativity rate, defined as the proportion of subjects who have at least one negative MRD sample at any time point prior to start of subsequent anti-lymphoma therapy
Time to next anti-lymphoma therapy (TTNT)	throughout the study and up to 5 years following the last patient first dose	TTNT is calculated as the time from randomization to date of initiation of new anti-lymphoma therapy.
Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)	throughout the study and up to 5 years following the last patient first dose	monitor change from baseline in health-related quality of life over time and in relation to treatment

Trial Locations

Locations (200)

Community Health Network Cancer Center North; 🇺🇸 Indianapolis, Indiana, United States

TriHealth Cancer Institute- Good Samaritan Hospital; 🇺🇸 Cincinnati, Ohio, United States

Beijing Cancer Hospital; 🇨🇳 Beijing, China

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, China

The First Hospital of Jilin University; 🇨🇳 Changchun, China

Guangxi Medical University Affiliated Tumor Hospital; 🇨🇳 Guangxi, China

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, China

Hubei Cancer Hospital; 🇨🇳 Hubei, China

Hunan Cancer Hospital; 🇨🇳 Hunan, China

Qingdao Central Hospital; 🇨🇳 Qingdao, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, China

Shanxi Provincial Cancer Hospital; 🇨🇳 Shanxi, China

Shengjing Hospital of China Medical University; 🇨🇳 Shenyang, China

Shenzhen Peoples Hospital; 🇨🇳 Shenzhen, China

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, China

EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology; 🇨🇳 Wuhan, China

Yantai Yuhuangding Hospital; 🇨🇳 Yantai, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine; 🇨🇳 Zhenjiang, China

Aalborg Universitetshospital; 🇩🇰 Aalborg, Denmark

Aarhus University Hospital, Department of Hematology, Clinical Research Unit C116; 🇩🇰 Aarhus, Denmark

Clinical Research Unit, Roskilde Sygehus; 🇩🇰 Roskilde, Denmark

Vejle Hospital; 🇩🇰 Vejle, Denmark

HUS Cancer Center/ Clinical Trial Unit; 🇫🇮 Helsinki, Finland

Oulu university hospital, Department of hematology; 🇫🇮 Oulu, Finland

Audrey ALEME; 🇫🇷 Amiens, France

Centre Hospitalier de la Côte Basque; 🇫🇷 Bayonne, France

CHRU de Brest - Hospital Morvan; 🇫🇷 Brest, France

Centre Léon Bérard; 🇫🇷 Lyon, France

CHU Caen - IHBN; 🇫🇷 Caen, France

Groupe Hospitalier de La Rochelle; 🇫🇷 La Rochelle, France

CHU de LIMOGES; 🇫🇷 Limoges, France

Hopital de la Conception APHM; 🇫🇷 Marseille, France

CHU de Nantes - Hôtel Dieu; 🇫🇷 Nantes, France

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Clinique Victor Hugo; 🇫🇷 Paris, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

CHU de Bordeaux Hôpital Haut-Lévêque; 🇫🇷 Pessac, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

Centre Hospitalier Rene Dubos; 🇫🇷 Pontoise, France

CHU de Poitiers - Hôpital la Milétrie; 🇫🇷 Poitiers, France

Ch Cornouaille; 🇫🇷 Quimper, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

CHRU Tours Hôpital Bretonneau; 🇫🇷 Tours, France

Uniklinik Köln, Klinik I für Innere Medizin, CIO Gebäude 70, 5.094; 🇩🇪 Cologne, Germany

Universitaetsklinikum Essen; 🇩🇪 Essen, Germany

Universitätsklinikum Schleswig-Holstein Medizinische Klinik II Hämatologie und Onkologie; 🇩🇪 Kiel, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Germany

National Institute of Oncology; 🇭🇺 Budapest, Hungary

Semmelweis Egyetem Belgyógyászati és Onkológiai Klinika; 🇭🇺 Budapest, Hungary

Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika, Hematologia; 🇭🇺 Debrecen, Hungary

Belgyógyászati osztály Markhot Ferenc Kórház; 🇭🇺 Eger, Hungary

Petz Aladar Egyetemi Oktato Korhaz; 🇭🇺 Győr, Hungary

Josa Andras Teaching Hospital, Hematology Dept; 🇭🇺 Nyiregyhaza, Hungary

University of Pecs 1st. Internal medicine Clinic Dept. Hematology; 🇭🇺 Pécs, Hungary

Szegedi Tudományegyetem II. sz. Belgyogyaszat, Hematologia; 🇭🇺 Szeged, Hungary

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz; 🇭🇺 Szekesfehervar, Hungary

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel

Rambam Health Care Center; 🇮🇱 Haifa, Israel

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel

Ospedale Santa Maria delle Croci; 🇮🇹 Ravenna, Italy

National Cancer Center Hospital East; 🇯🇵 Kashiwa, Japan

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Azienda Ospedaliero - Universitaria Maggiore delle Carita SCDU Ematologia building C; 🇮🇹 Novara, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza; 🇮🇹 San Giovanni Rotondo, Italy

SC di Ematologia - AON SS Antonio e Biagio e Cesare Arrigo; 🇮🇹 Venezia, Italy

Chugoku Central Hospital; 🇯🇵 Fukuyama, Japan

Hokkaido University Hospital; 🇯🇵 Hokkaido, Japan

Matsuyama Red Cross Hospital; 🇯🇵 Matsuyama, Japan

NHO Nagoya Medical Center; 🇯🇵 Nagoya, Japan

IRCCS Istituto Tumori Giovanni Paolo II Bari; 🇮🇹 Bari, Italy

Azienda Socio Sanitaria Territoriale Sette Laghi (Presidio Ospedale di Circolo e Fondazione Macchi); 🇮🇹 Bergamo, Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili); 🇮🇹 Brescia, Italy

San Raffaele Hospital; 🇮🇹 Milan, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.); 🇮🇹 Meldola, Italy

Kyushu University Hospital; 🇯🇵 Fukuoka, Japan

Istituto Oncologico Europeo; 🇮🇹 Milan, Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I Università di Roma La Sapienza, Dip Med Tra; 🇮🇹 Rome, Italy

Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) Ospedale Maggiore di Trieste; 🇮🇹 Trieste, Italy

Fukushima Medical University Hospital; 🇯🇵 Fukushima, Japan

Mie University Hospital; 🇯🇵 Mie, Japan

Kyoto University Medical Hospital; 🇯🇵 Kyoto, Japan

Japanese Red Cross Nagoya Daini Hospital; 🇯🇵 Nagoya, Japan

National Cancer Center Hospital; 🇯🇵 Tokyo, Japan

Tokai University Hospital; 🇯🇵 Tokyo, Japan

Okayama University Hospital; 🇯🇵 Okayama, Japan

Tohoku University Hospital; 🇯🇵 Sendai, Japan

Keio University Hospital; 🇯🇵 Tokyo, Japan

Fujita Health University Hospital; 🇯🇵 Toyoake, Japan

Yamagata University Hospital; 🇯🇵 Yamagata, Japan

Kindai University Hospital; 🇯🇵 Ōsaka-sayama, Japan

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of

Pusan National University Hosptial; 🇰🇷 Busan, Korea, Republic of

Keimyung University Dongsan Hospital; 🇰🇷 Daegu, Korea, Republic of

Chonbuk National University Hospital; 🇰🇷 Geumam, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of

Rijnstate Arnhem; 🇳🇱 Arnhem, Netherlands

Amphia Ziekenhuis, Interne Geneeskunde, Oncologie. Route 43; 🇳🇱 Breda, Netherlands

Albert Schweitzer Ziekenhuis; 🇳🇱 Dordrecht, Netherlands

Admiraal de Ruyter Ziekenhuis; 🇳🇱 Goes, Netherlands

Bravis Ziekenhuis; 🇳🇱 Roosendaal, Netherlands

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

Franciscus Gasthuis And Vlietland; 🇳🇱 Rotterdam, Netherlands

Oslo University Hospital location Radium hospital; 🇳🇴 Oslo, Norway

St. Olavs Hospital HF; 🇳🇴 Trondheim, Norway

Pratia Onkologia Katowice; 🇵🇱 Katowice, Poland

Pratia MCM Kraków; 🇵🇱 Kraków, Poland

Centrum Medyczne Pratia Poznan; 🇵🇱 Skorzewo, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu; 🇵🇱 Wrocław, Poland

Instytut Centrum Zdrowia Matki Polki; 🇵🇱 Łódź, Poland

Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; 🇵🇱 Łódź, Poland

State Autonomous Institution of Healthcare Republican Clinical Oncological Dispensary of the Ministr; 🇷🇺 Kazan, Russian Federation

State Budgetary Institution of Healthcare Leningrad Regional Clinical Hospital; 🇷🇺 Leningrad, Russian Federation

Federal State Budgetary Institution of Science; 🇷🇺 Moscow, Russian Federation

Federal State Budgetary Institution; 🇷🇺 Moscow, Russian Federation

State Budgetary Institution of Healthcare of Nizhniy Novgorod region, 1st inpatient facility, 5th fl; 🇷🇺 Nizhny Novgorod, Russian Federation

Federal State Budgetary Institution V.A. Almazov National Medical Research Center of the Ministry of; 🇷🇺 Saint Petersburg, Russian Federation

National University Hospital; 🇸🇬 Kent Ridge, Singapore

Clinical Trials and Research Centre; 🇸🇬 Singapore, Singapore

ICO l'Hospitalet - Hospital Duran i Reynals; 🇪🇸 Barcelona, Spain

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore

ICO Badalona - Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Hospita Universitario Puerta Del Mar; 🇪🇸 Cadiz, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital San Pedro de Alcántara; 🇪🇸 Cáceres, Spain

Hospital Arnau de Vilanova; 🇪🇸 Lleida, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Karolinska university Hospital; 🇸🇪 Stockholm, Sweden

Hospital Universitario Virgen De Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Md Anderson Cancer Center; 🇪🇸 Madrid, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan

Tri-Service General Hospital; 🇨🇳 Taipei, Taiwan

Ankara University Medical Faculty; 🇹🇷 Ankara, Turkey

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi; 🇹🇷 Ankara, Turkey

Gazi University Medical Faculty; 🇹🇷 Ankara, Turkey

Amerikan Hospital; 🇹🇷 Istanbul, Turkey

Iqvia Tibbi Istatistik; 🇹🇷 Istanbul, Turkey

Istanbul University Medical Faculty; 🇹🇷 Istanbul, Turkey

Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi; 🇹🇷 Istanbul, Turkey

Dokuz Eylul University Medical Faculty; 🇹🇷 İzmir, Turkey

Ege University Medical Faculty; 🇹🇷 İzmir, Turkey

Tekirdag Namik Kemal University; 🇹🇷 Tekirdağ, Turkey

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey

Haematology - University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Guys and St Thomas NHS Foundation Trust; 🇬🇧 London, United Kingdom

Hammersmith Hospital; 🇬🇧 London, United Kingdom

Norfolk and Norwich University Hospitals NHS Foundation Trust; 🇬🇧 Norwich, United Kingdom

Royal Cornwall Hospital; 🇬🇧 Truro, United Kingdom

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom

University Hospital Southampton; 🇬🇧 Southampton, United Kingdom

Royal Marsden NHS Foundation Trust (Sutton); 🇬🇧 Sutton, United Kingdom

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

University of Kentucky Markey Cancer Center; 🇺🇸 Lexington, Kentucky, United States

LDS Hospital; 🇺🇸 Salt Lake City, Utah, United States

Concord Repatriation General Hospital; 🇦🇺 Concord, Australia

Fondazione IRCCS Policlinico San matteo; 🇮🇹 Pavia, Italy

Westmead Hospital; 🇦🇺 Westmead, Australia

Uniklinikum Salzburg, Universitätsklinik für Innere Medizin III der PMU; 🇦🇹 Salzburg, Austria

Wake Forest Baptist Health; 🇺🇸 Winston-Salem, North Carolina, United States

Henry Ford Health System; 🇺🇸 Jackson, Michigan, United States

Flinders Medical Centre; 🇦🇺 Bedford Park, Australia

Peninsula Private Hospital Clinical Trials Unit; 🇦🇺 Frankston, Australia

Uniwersyteckie Centrum Kliniczne, Klinika Hematologii i Transplantologii; 🇵🇱 Gdańsk, Poland

Calvary Mater Newcastle; 🇦🇺 Waratah, Australia

Indiana Blood and Marrow Transplantation; 🇺🇸 Indianapolis, Indiana, United States

Ordensklinikum Linz Barmherzige Schwestern; 🇦🇹 Linz, Austria

Ordensklinikum Linz GmbH Elisabethinen; 🇦🇹 Linz, Austria

ZNA Middelheim; 🇧🇪 Antwerp, Belgium

Icon Cancer Centre Corporate Office; 🇦🇺 South Brisbane, Australia

UZ Brussel; 🇧🇪 Jette, Belgium

Hôpital de Jolimont; 🇧🇪 La Louvière, Belgium

CHU de Quebec-Universite Laval; 🇨🇦 Québec City, Canada

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

AZ Nikolaas- Verenigde Ziekenhuizen van Waas en Durme; 🇧🇪 Sint-Niklaas, Belgium

West China Hospital, Sichuan University; 🇨🇳 Chengdu, China

The Second Hospital of Dalian Medical University; 🇨🇳 Dalian, China

Guangdong Provincial Peoples Hospital; 🇨🇳 Guangdong, China

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Universitair Ziekenhuis gasthuisberg Leuven; 🇧🇪 Leuven, Belgium

AZ Turnhout, Campus Sint-Elisabeth; 🇧🇪 Turnhout, Belgium

Affiliated Hospital of Hebei University; 🇨🇳 Baoding, China

The Catholic University of Korea Seoul St. Marys Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of