Lung Cancer Clinical Trial

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)

Summary

The purpose of this study is to evaluate the use of investigational agents (MK-4830, MK-5890 and Lenvatinib (MK-7902)) in combination with pembrolizumab 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 MK-5890 (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 MK-5890 (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 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
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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT04924101

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 46 Locations for this study

See Locations Near You

Banner MD Anderson Cancer Center ( Site 0102)
Gilbert Arizona, 85234, United States More Info
Study Coordinator
Contact
480-256-6444
University of Colorado Anschutz Medical Campus ( Site 0104)
Aurora Colorado, 80045, United States More Info
Study Coordinator
Contact
303-724-5000
Georgia Cancer Specialists ( Site 0106)
Atlanta Georgia, 30341, United States More Info
Study Coordinator
Contact
770-496-9400
Parkview Research Center at Parkview Regional Medical Center ( Site 0130)
Fort Wayne Indiana, 46845, United States More Info
Study Coordinator
Contact
833-724-8326
Baptist Health Lexington-Research ( Site 0108)
Lexington Kentucky, 40503, United States More Info
Study Coordinator
Contact
270-575-2100
MFSMC-HJWCI-Oncology Research ( Site 0128)
Baltimore Maryland, 21237, United States More Info
Study Coordinator
Contact
443-777-8876
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0122)
Omaha Nebraska, 68130, United States More Info
Study Coordinator
Contact
402-334-4733
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0129)
Omaha Nebraska, 68130, United States More Info
Study Coordinator
Contact
402-334-4773
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0114)
Mineola New York, 11501, United States More Info
Study Coordinator
Contact
516-663-2988
Memorial Sloan Kettering Cancer Center ( Site 0115)
New York New York, 10065, United States More Info
Study Coordinator
Contact
212-639-2000
Cleveland Clinic-Taussig Cancer Center ( Site 0116)
Cleveland Ohio, 44195, United States More Info
Study Coordinator
Contact
216-444-2200
UPMC Hillman Cancer Center ( Site 0127)
Pittsburgh Pennsylvania, 15232, United States More Info
Study Coordinator
Contact
412-623-5898
St Francis Cancer Center-Research Office ( Site 0117)
Greenville South Carolina, 29607, United States More Info
Study Coordinator
Contact
864-255-1901
Virginia Cancer Institute ( Site 0119)
Richmond Virginia, 23229, United States More Info
Study Coordinator
Contact
804-287-3000
Klinik Penzing-2. Lungenabteilung ( Site 2101)
Vienna Wien, 1140, Austria More Info
Study Coordinator
Contact
+4319106042003
Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 2100)
Wien , 1210, Austria More Info
Study Coordinator
Contact
0043 1 27700 5634
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2003)
Hamilton Ontario, L8V 5, Canada More Info
Study Coordinator
Contact
9053879495
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2005)
Kingston Ontario, K7L 2, Canada More Info
Study Coordinator
Contact
(613) 549-6666 x4502
St. Marys Hospital Center ( Site 2000)
Montreal Quebec, H3T 1, Canada More Info
Study Coordinator
Contact
514-345-3511
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2800)
Szolnok Jasz-Nagykun-Szolnok, 5004, Hungary More Info
Study Coordinator
Contact
36209323256
Országos Korányi Pulmonológiai Intézet-XIV. Tüdöbelgyógyászat ( Site 2806)
Budapest Pest, 1121, Hungary More Info
Study Coordinator
Contact
+36305762630
Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 2801)
Törökbálint Pest, 2045, Hungary More Info
Study Coordinator
Contact
+36204634328
Zala Megyei Szent Rafael Kórház-Pulmonológia ( Site 2805)
Zalaegerszeg Zala, 8900, Hungary More Info
Study Coordinator
Contact
3692501527
Semmelweis University-Pulmonológiai Klinika ( Site 2802)
Budapest , 1083, Hungary More Info
Study Coordinator
Contact
+36208259181
Rambam Health Care Campus-Oncology ( Site 2600)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
+97247776700
Shaare Zedek Medical Center ( Site 2602)
Jerusalem , 91031, Israel More Info
Study Coordinator
Contact
+972587040620
Meir Medical Center ( Site 2601)
Kfar Saba , 44281, Israel More Info
Study Coordinator
Contact
+97297472414
Rabin Medical Center-Oncology ( Site 2604)
Petah Tikva , 49414, Israel More Info
Study Coordinator
Contact
+9729378101
Sheba Medical Center-ONCOLOGY ( Site 2603)
Ramat Gan , 52621, Israel More Info
Study Coordinator
Contact
+97235307096
Ospedale San Raffaele-Oncologia Medica ( Site 2303)
Milano Lombardia, 20132, Italy More Info
Study Coordinator
Contact
390226436627
ospedale le scotte-U.O.C. Immunoterapia Oncologica ( Site 2300)
Siena Toscana, 53100, Italy More Info
Study Coordinator
Contact
390577586335
Istituto Europeo di Oncologia IRCCS-Divisione di Oncologia Toracica ( Site 2304)
Milano , 20141, Italy More Info
Study Coordinator
Contact
390257489440
Chungbuk National University Hospital ( Site 1107)
Cheongju-si Chungbuk, 28644, Korea, Republic of More Info
Study Coordinator
Contact
+82432696114
Seoul National University Bundang Hospital ( Site 1104)
Seongnam Kyonggi-do, 13620, Korea, Republic of More Info
Study Coordinator
Contact
+82-31-787-7003
The Catholic University Of Korea St. Vincent's Hospital ( Site 1106)
Suwon-si Kyonggi-do, 16247, Korea, Republic of More Info
Study Coordinator
Contact
+8215778588
Seoul National University Hospital ( Site 1101)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
+82220722995
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1105)
Seoul , 03722, Korea, Republic of More Info
Study Coordinator
Contact
+8222280880
Asan Medical Center-Department of Oncology ( Site 1103)
Seoul , 05505, Korea, Republic of More Info
Study Coordinator
Contact
+8230103214
Samsung Medical Center ( Site 1100)
Seoul , 06351, Korea, Republic of More Info
Study Coordinator
Contact
82-2-3410-3438
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier
Warszawa Mazowieckie, 02-78, Poland More Info
Study Coordinator
Contact
+48225463066
Samodzielny Publiczny Zespó Grulicy i Chorób Puc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemi
Olsztyn Warminsko-mazurskie, 10-35, Poland More Info
Study Coordinator
Contact
48895322973
Krasnoyarsk Regional Oncology Dispensary, Named after Krizhanovsky ( Site 2708)
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
N.N.Petrov Research Institute of Oncology-Department of Chemotherapy and Innovative Technologies ( S
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
GBUZ "SPb CRPCstmc(o)" ( Site 2705)
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
Scientific research institution of oncology named after N.N. Petrov-Thoracic oncology ( Site 2704)
Sankt-Peterburg , 19775, Russian Federation
Instituto Catalan de Oncologia - Hospital Duran i Reynals ( Site 2403)
L'Hospitalet de Llobregat Cataluna, 08908, Spain More Info
Study Coordinator
Contact
34932607744
Hospital Insular de Gran Canaria ( Site 2402)
Las Palmas de Gran Canaria Las Palmas, 35001, Spain More Info
Study Coordinator
Contact
+34928441738
Hospital Universitari Vall d'Hebron-Oncology ( Site 2401)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
+34934894375
Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 2502)
st.Gallen Sankt Gallen, 9007, Switzerland More Info
Study Coordinator
Contact
+41714941111

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

120

Study ID:

NCT04924101

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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