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COMPLETED
NCT04924101
PHASE2

Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the use of investigational agents (MK-4830, boserolimab (MK-5890) and lenvatinib (MK-7902)) in combination with pembrolizumab (MK-3475) and etoposide/platinum chemotherapy for the first-line treatment of participants with extensive-stage small cell Lung Cancer (ES-SCLC). No formal hypothesis testing will be performed for this study.

Official title: A Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Etoposide and Cisplatin or Carboplatin for the First-Line Treatment of Participants With Extensive-Stage Small Cell Lung Cancer (KEYNOTE-B99)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

126

Start Date

2021-07-15

Completion Date

2025-06-23

Last Updated

2026-07-01

Healthy Volunteers

No

Interventions

BIOLOGICAL

Pembrolizumab

IV infusion

BIOLOGICAL

MK-4830

IV infusion

BIOLOGICAL

Boserolimab

IV infusion

DRUG

Lenvatinib

Oral capsule

DRUG

Etoposide

IV infusion

DRUG

Cisplatin

IV infusion

DRUG

Carboplatin

IV infusion

Locations (49)

Banner MD Anderson Cancer Center ( Site 0102)

Gilbert, Arizona, United States

University of Colorado Anschutz Medical Campus ( Site 0104)

Aurora, Colorado, United States

Georgia Cancer Specialists ( Site 0106)

Atlanta, Georgia, United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0130)

Fort Wayne, Indiana, United States

Baptist Health Lexington-Research ( Site 0108)

Lexington, Kentucky, United States

MFSMC-HJWCI-Oncology Research ( Site 0128)

Baltimore, Maryland, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0122)

Omaha, Nebraska, United States

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0129)

Omaha, Nebraska, United States

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0114)

Mineola, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 0115)

New York, New York, United States

Cleveland Clinic-Taussig Cancer Center ( Site 0116)

Cleveland, Ohio, United States

UPMC Hillman Cancer Center ( Site 0127)

Pittsburgh, Pennsylvania, United States

St Francis Cancer Center-Research Office ( Site 0117)

Greenville, South Carolina, United States

Virginia Cancer Institute ( Site 0119)

Richmond, Virginia, United States

Klinik Penzing-2. Lungenabteilung ( Site 2101)

Vienna, State of Vienna, Austria

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2100)

Vienna, Austria

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2003)

Hamilton, Ontario, Canada

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2005)

Kingston, Ontario, Canada

St. Marys Hospital Center ( Site 2000)

Montreal, Quebec, Canada

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2800)

Szolnok, Jász-Nagykun-Szolnok, Hungary

Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 2806)

Budapest, Pest County, Hungary

Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 2801)

Törökbálint, Pest County, Hungary

Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 2805)

Zalaegerszeg, Zala County, Hungary

Semmelweis University-Pulmonológiai Klinika ( Site 2802)

Budapest, Hungary

Rambam Health Care Campus-Oncology ( Site 2600)

Haifa, Israel

Shaare Zedek Medical Center ( Site 2602)

Jerusalem, Israel

Meir Medical Center ( Site 2601)

Kfar Saba, Israel

Rabin Medical Center-Oncology ( Site 2604)

Petah Tikva, Israel

Sheba Medical Center-ONCOLOGY ( Site 2603)

Ramat Gan, Israel

Ospedale San Raffaele-Oncologia Medica ( Site 2303)

Milan, Lombardy, Italy

ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 2300)

Siena, Tuscany, Italy

Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 2304)

Milan, Italy

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

Warsaw, Masovian Voivodeship, Poland

Samodzielny Publiczny Zespó Grulicy i Chorób Puc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemi

Olsztyn, Warmian-Masurian Voivodeship, Poland

Krasnoyarsk Regional Oncology Dispensary, Named after Krizhanovsky ( Site 2708)

Krasnoyarsk, Krasnoyarsk Krai, Russia

GBUZ "SPb CRPCstmc(o)" ( Site 2705)

Saint Petersburg, Sankt-Peterburg, Russia

N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S

Saint Petersburg, Sankt-Peterburg, Russia

Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 2704)

Saint Petersburg, Russia

Seoul National University Bundang Hospital ( Site 1104)

Seongnam, Kyonggi-do, South Korea

The Catholic University Of Korea St. Vincent's Hospital ( Site 1106)

Suwon, Kyonggi-do, South Korea

Chungbuk National University Hospital ( Site 1107)

Cheongju-si, North Chungcheong, South Korea

Seoul National University Hospital ( Site 1101)

Seoul, South Korea

Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1105)

Seoul, South Korea

Asan Medical Center-Department of Oncology ( Site 1103)

Seoul, South Korea

Samsung Medical Center ( Site 1100)

Seoul, South Korea

Instituto Catalan de Oncologia - Hospital Duran i Reynals ( Site 2403)

L'Hospitalet de Llobregat, Catalonia, Spain

Hospital Insular de Gran Canaria ( Site 2402)

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitari Vall d'Hebron-Oncology ( Site 2401)

Barcelona, Spain

Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 2502)

Sankt Gallen, Canton of St. Gallen, Switzerland