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)
NCT ID: NCT04924101
Last Updated: 2025-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
126 participants
INTERVENTIONAL
2021-07-15
2025-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab + MK-4830 + Chemotherapy
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until disease progression (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
Pembrolizumab
IV infusion
MK-4830
IV infusion
Etoposide
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Pembrolizumab + Boserolimab + Chemotherapy
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
Pembrolizumab
IV infusion
Boserolimab
IV infusion
Etoposide
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Pembrolizumab + Lenvatinib + Chemotherapy
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally up to Cycles 1-4 cycles and up to 20 mg QD orally for Cycles 5-31 or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
Pembrolizumab
IV infusion
Lenvatinib
Oral capsule
Etoposide
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Interventions
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Pembrolizumab
IV infusion
MK-4830
IV infusion
Boserolimab
IV infusion
Lenvatinib
Oral capsule
Etoposide
IV infusion
Cisplatin
IV infusion
Carboplatin
IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has ES-SCLC defined as Stage IV (T any, N any, M1a/b/c) by the American Joint Committee on Cancer, Eighth Edition
* Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is as follows: Lenvatinib (7 days); Etoposide, Cisplatin, or Carboplatin (180 days) and Pembrolizumab, MK-4830, or (no contraception measures); refrain from donating sperm plus either be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or must agree to use contraception per protocol unless confirmed to be azoospermic
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman/women of childbearing potential (WOCBP) or is a WOCBP and uses a contraceptive method that is highly effective with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows: Lenvatinib (30 days), Etoposide, Cisplatin, or Carboplatin (180 days), and Pembrolizumab, MK-4830, or Boserolimab (120 days)
* A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours (urine test) or 72 hours (serum test) before the first dose of study intervention
* Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention
* Has measurable disease per RECIST 1.1 as assessed by local site investigator/radiology and verified by blinded independent central review (BICR)
* Submits an archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated where such sample exist
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before randomization
* Has adequate organ function within 10 days before the first dose of study intervention
* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no changes in antihypertensive medications within 1 week before randomization
Exclusion Criteria
* Has a preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
* Has urine protein ≥1 g/24 hours
* Has a left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multiple gated acquisition (MUGA) or echocardiogram (ECHO)
* Prolongation of QT interval with Fridericia's correction (QTcF) interval to \>480 ms
* Has clinically significant cardiovascular disease or major arterial thromboembolic event within 12 months before first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
* Has active hemoptysis within 3 weeks before the first dose of study intervention
* Has gastrointestinal malabsorption or any other condition that might affect oral study intervention absorption
* Has serious nonhealing wound, ulcer, or bone fracture within 28 days before first dose of study intervention
* Has any major hemorrhage or venous thromboembolic events within 3 months before the first dose of study intervention. Participants with venous thrombosis diagnosed more than 3 months before the first dose of study intervention must be on stable doses of anticoagulants
* Has a history of inflammatory bowel disease
* Has a history of a gastrointestinal perforation within 6 months before the first dose of study intervention
* Is considered a poor medical risk due to a serious, uncontrolled medical disorder or nonmalignant systemic disease
* Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Has received prior treatment (chemotherapy, radiotherapy, or surgical resection) including investigational agents for SCLC
* Is expected to require any other form of antineoplastic therapy for SCLC, including radiation therapy, while on study
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation. A participant that meets this exclusion criterion but is otherwise deemed eligible for the study may be randomized across the specific intervention groups.
* Has symptomatic ascites, pleural effusion, or pericardial effusion. A participant who is clinically stable following treatment for these conditions is eligible
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with brain metastases may participate only if they satisfy all of the following: a) Completed treatment at least 14 days before the first dose of study intervention b) Have no evidence of new or enlarging brain metastases confirmed by posttreatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and c) Are neurologically stable without the need for steroids for at least 7 days before the first dose of study intervention as per local site assessment. Participants with untreated brain metastases will be allowed if they are asymptomatic, the investigator determines there is no immediate CNS-specific treatment required, there is no significant surrounding edema, and the brain metastases are of 5 mm or less in size and 3 or fewer in number
* Has a history of severe hypersensitivity reaction to any study intervention and/or any of its excipients
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has a known history of, or active, neurologic paraneoplastic syndrome
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection and/or Hepatitis B virus infection or an active Hepatitis C infection
* Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
* Has had an allogenic tissue/solid organ transplant
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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, 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
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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MK-3475-B99
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-B99
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506538-56-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1293-9965
Identifier Type: REGISTRY
Identifier Source: secondary_id
3475-B99
Identifier Type: -
Identifier Source: org_study_id
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