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Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)
Sponsor: Merck Sharp & Dohme LLC
Summary
This study is a rolling arm study of investigational agents as monotherapy or in combination with pembrolizumab in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study.
Official title: A Phase 1b/2 Study to Evaluate the Efficacy and Safety of Investigational Agents as Monotherapy or in Combination With Pembrolizumab for the Treatment of Participants With PD-1/L1-refractory Extensive-Stage Small Cell Lung Cancer in Need of Second-Line Therapy (KEYNOTE-B98)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2021-08-19
Completion Date
2029-12-10
Last Updated
2026-03-19
Healthy Volunteers
No
Conditions
Interventions
coformulation pembrolizumab/quavonlimab
Intravenous (IV) infusion
lenvatinib
Oral administration
MK-4830
IV infusion
coformulation favezelimab/pembrolizumab
IV infusion
R-DXd
IV Infusion
Locations (48)
Banner MD Anderson Cancer Center ( Site 0152)
Gilbert, Arizona, United States
Northside Hospital-Northside Hospital Oncology Network ( Site 0156)
Atlanta, Georgia, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 0180)
Fort Wayne, Indiana, United States
Baptist Health Lexington-Research ( Site 0158)
Lexington, Kentucky, United States
University of Kentucky Chandler Medical Center-Medical Oncology ( Site 0157)
Lexington, Kentucky, United States
MFSMC-HJWCI-Oncology Research ( Site 0178)
Baltimore, Maryland, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0172)
Omaha, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0179)
Omaha, Nebraska, United States
Cleveland Clinic-Taussig Cancer Center ( Site 0166)
Cleveland, Ohio, United States
UPMC Hillman Cancer Center ( Site 0177)
Pittsburgh, Pennsylvania, United States
St Francis Cancer Center-Research Office ( Site 0167)
Greenville, South Carolina, United States
Virginia Cancer Institute ( Site 0169)
Richmond, Virginia, United States
Westmead Hospital-Department of Medical Oncology ( Site 4004)
Westmead, New South Wales, Australia
The Prince Charles Hospital-Oncology Clinical Trials ( Site 4003)
Brisbane, Queensland, Australia
Monash Health-Oncology Research ( Site 4005)
Clayton, Victoria, Australia
Hollywood Private Hospital-Medical Oncology ( Site 4001)
Perth, Western Australia, Australia
Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 3101)
Vienna, Austria
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 3100)
Vienna, Austria
Cross Cancer Institute ( Site 3004)
Edmonton, Alberta, Canada
Princess Margaret Cancer Centre ( Site 3003)
Toronto, Ontario, Canada
St. Marys Hospital Center ( Site 3000)
Montreal, Quebec, Canada
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 3800)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Rambam Health Care Campus-Oncology ( Site 3600)
Haifa, Israel
Shaare Zedek Medical Center-Oncology ( Site 3602)
Jerusalem, Israel
Meir Medical Center. ( Site 3601)
Kfar Saba, Israel
Rabin Medical Center-Oncology ( Site 3604)
Petah Tikva, Israel
Sheba Medical Center-ONCOLOGY ( Site 3603)
Ramat Gan, Israel
Humanitas-U.O di Oncologia medica ed Ematologia ( Site 3301)
Rozzano, Milano, Italy
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 3300)
Siena, Tuscany, Italy
Ospedale San Raffaele-Oncologia Medica ( Site 3303)
Milan, Italy
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 3304)
Milan, Italy
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 3900)
Warsaw, Masovian Voivodeship, Poland
Warminsko-Mazurskie Centrum Chorob Płuc w Olsztynie ( Site 3903)
Olsztyn, Warmian-Masurian Voivodeship, Poland
Krasnoyarsk Regional Oncology Dispensary, Named after Krizhanovsky ( Site 3708)
Krasnoyarsk, Krasnoyarsk Krai, Russia
Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 3702)
Saint Petersburg, Leningradskaya Oblast', Russia
GBUZ LOKB-Oncology department #1 ( Site 3701)
Saint Petersburg, Sankt-Peterburg, Russia
GBUZ "SPb CRPCstmc(o)" ( Site 3705)
Saint Petersburg, Sankt-Peterburg, Russia
N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( Site 3703)
Saint Petersburg, Sankt-Peterburg, Russia
Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 3704)
Saint Petersburg, Russia
Seoul National University Bundang Hospital-Medical Oncology ( Site 4104)
Seongnam, Kyonggi-do, South Korea
Chungbuk National University Hospital ( Site 4106)
Cheongju-si, North Chungcheong, South Korea
Seoul National University Hospital ( Site 4101)
Seoul, South Korea
Asan Medical Center-Lung Cancer Center ( Site 4103)
Seoul, South Korea
Samsung Medical Center ( Site 4100)
Seoul, South Korea
Instituto Catalan de Oncologia - Hospital Duran i Reynals ( Site 3403)
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 3401)
Barcelona, Spain
Hospital Clinic de Barcelona ( Site 3404)
Barcelona, Spain
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 3502)
Sankt Gallen, Canton of St. Gallen, Switzerland