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)

Completed · Phase 2

Conditions studied: Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT04924101

Run by

Merck Sharp & Dohme LLC

People needed

126

Starts

2021-07-15

Expected to finish

2025-06-23

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has histologically or cytologically confirmed diagnosis of extensive-stage small cell lung cancer (ES-SCLC) in need of first-line therapy
• 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

You may not qualify if…

• Has had major surgery within 3 weeks before first dose of study interventions
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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