RecruitingPhase 1Phase 2NCT04938817

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)

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)

Sponsor

Merck Sharp & Dohme LLC

Enrollment

110 participants

Start Date

Aug 19, 2021

Study Type

INTERVENTIONAL

Conditions

Small Cell Lung Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests several new drug combinations with the immunotherapy drug pembrolizumab as second-line treatment options for people with extensive-stage small cell lung cancer (SCLC) — an aggressive form of lung cancer — whose disease has progressed after initial treatment. **You may be eligible if...** - You have been diagnosed with extensive-stage small cell lung cancer (cancer that has spread beyond the lung) - Your cancer progressed after receiving first-line treatment that included an immunotherapy drug (anti-PD-1 or PD-L1) - You have received exactly one prior line of treatment for SCLC - You are in reasonably good health **You may NOT be eligible if...** - You have received more than one prior treatment for SCLC - You did not receive immunotherapy as part of your first treatment - You are pregnant or breastfeeding - You have serious uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALcoformulation pembrolizumab/quavonlimab

Intravenous (IV) infusion

DRUGlenvatinib

Oral administration

BIOLOGICALMK-4830

IV infusion

BIOLOGICALcoformulation favezelimab/pembrolizumab

IV infusion

BIOLOGICALR-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

View Full Details on ClinicalTrials.gov

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NCT04938817

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