Lung Cancer Clinical Trial

Pembrolizumab/Vibostolimab (MK-7684A) or Atezolizumab in Combination With Chemotherapy in First Line Treatment of Extensive-Stage Small Cell Lung Cancer (MK-7684A-008, KEYVIBE-008)

Summary

This study will evaluate the combination of a fixed dose pembrolizumab/vibostolimab co-formulation (MK-7684A) with etoposide/platinum chemotherapy followed by MK-7684A compared to the combination of atezolizumab with etoposide/platinum chemotherapy followed by atezolizumab in the first-line treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). The primary hypothesis is, with respect to overall survival, MK-7684A in combination with the background therapy of etoposide/platinum followed by MK-7684A, is superior to atezolizumab in combination with the background therapy of etoposide/platinum followed by atezolizumab.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has histologically or cytologically confirmed diagnosis of 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 or T3-T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan
Males agree to use contraception, refrain from donating sperm, and abstain from heterosexual intercourse
Females are not pregnant or breastfeeding, is not a woman of childbearing potential (WOCBP) or is a WOCBP who uses a highly effective contraceptive method, or is abstinent from heterosexual intercourse
Has measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Has a predicted life expectancy of >3 months

Exclusion Criteria:

Is considered a poor medical risk due to a serious, uncontrolled medical disorder or non-malignant systemic disease
Has received prior treatment for Small Cell Lung Cancer (SCLC)
Is expected to require any other form of antineoplastic therapy for SCLC while on study
Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
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
Has a history of severe hypersensitivity reaction (≥Grade 3) 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
Has a known history of Hepatitis B or known active Hepatitis C virus infection
Has had an allogenic tissue/solid organ transplant
Has had major surgery within prior 3 weeks or has not recovered adequately from toxicity and/or complications from an intervention prior to receiving the first dose of study intervention
Has symptomatic ascites or pleural effusion

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT05224141

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 106 Locations for this study

See Locations Near You

Los Angeles Hematology Oncology Medical Group ( Site 0006)
Los Angeles California, 90017, United States More Info
Study Coordinator
Contact
213-977-1214
Boca Raton Regional Hospital-Lynn Cancer Institute ( Site 0014)
Boca Raton Florida, 33486, United States More Info
Study Coordinator
Contact
561-955-4800
Fort Wayne Medical Oncology and Hematology ( Site 0013)
Fort Wayne Indiana, 46804, United States More Info
Study Coordinator
Contact
260-436-0800
Cancer and Hematology Centers of Western Michigan ( Site 0001)
Grand Rapids Michigan, 49503, United States More Info
Study Coordinator
Contact
616-954-9800
Hattiesburg Clinic Hematology/Oncology ( Site 0003)
Hattiesburg Mississippi, 39401, United States More Info
Study Coordinator
Contact
601-261-1700
Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0005)
Lancaster Pennsylvania, 17604, United States More Info
Study Coordinator
Contact
717-544-9400
Blue Ridge Cancer Care ( Site 0015)
Blacksburg Virginia, 24060, United States More Info
Study Coordinator
Contact
540-381-5291
University of Virginia Cancer Center ( Site 0019)
Charlottesville Virginia, 22903, United States More Info
Study Coordinator
Contact
434-243-6303
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0201)
Mar del Plata Buenos Aires, B7600, Argentina More Info
Study Coordinator
Contact
542234963224
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0203)
ABB Caba, C1199, Argentina More Info
Study Coordinator
Contact
+541149590200
Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0200)
Buenos Aires Caba, C1431, Argentina More Info
Study Coordinator
Contact
541144031470
Sanatorio Parque ( Site 0202)
Rosario Santa Fe, 2000, Argentina More Info
Study Coordinator
Contact
54 0341 4200250
Hospital Provincial del Centenario ( Site 0205)
Rosario Santa Fe, 2002, Argentina More Info
Study Coordinator
Contact
543414724649
Nepean Hospital ( Site 2700)
Penrith New South Wales, 2747, Australia More Info
Study Coordinator
Contact
+61247343500
Calvary Mater Newcastle ( Site 2703)
Waratah New South Wales, 2298, Australia More Info
Study Coordinator
Contact
+61240143282
Frankston Hospital-Oncology and Haematology ( Site 2702)
Frankston Victoria, 3199, Australia More Info
Study Coordinator
Contact
+61397847175
Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 2701)
St Albans Victoria, 3021, Australia More Info
Study Coordinator
Contact
+61385959167
Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0505)
Linz Oberosterreich, 4020, Austria More Info
Study Coordinator
Contact
+4373276763220
Kepler Universitätsklinikum ( Site 0507)
Linz Oberosterreich, 4021, Austria More Info
Study Coordinator
Contact
004357680830
Medizinische Universität Graz ( Site 0504)
Graz Steiermark, 8036, Austria More Info
Study Coordinator
Contact
004331638512183
Lakeridge Health ( Site 0102)
Oshawa Ontario, L1G 2, Canada More Info
Study Coordinator
Contact
905-576-8711X35096
Anhui Cancer Hospital ( Site 2915)
Hefei Anhui, 23003, China More Info
Study Coordinator
Contact
0551-65320585
Beijing Cancer hospital-Thoracic Cancer Department A ( Site 2901)
Beijing Beijing, 10014, China More Info
Study Coordinator
Contact
010-88196456
Beijing Peking Union Medical College Hospital ( Site 2921)
Beijing Beijing, 10073, China More Info
Study Coordinator
Contact
13911235467
Fujian Provincial Cancer Hospital-oncology department ( Site 2904)
Fuzhou Fujian, 35001, China More Info
Study Coordinator
Contact
+8659187487329
Harbin Medical University Cancer Hospital-oncology of department ( Site 2920)
Harbin Heilongjiang, 15000, China More Info
Study Coordinator
Contact
15304503377
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 2912)
Wuhan Hubei, 43002, China More Info
Study Coordinator
Contact
13986252286
Hubei Cancer Hospital ( Site 2922)
Wuhan Hubei, 43007, China More Info
Study Coordinator
Contact
027-87670003
The First Affiliated Hospital of Soochow University ( Site 2913)
Suzhou Jiangsu, 21500, China More Info
Study Coordinator
Contact
0512-67972858
Jilin Cancer Hospital-GCP office ( Site 2909)
Changchun Jilin, 13000, China More Info
Study Coordinator
Contact
0431-80596607
The First Affiliated Hospital of Xi'an Jiaotong University-Oncology ( Site 2910)
Xi'an Shaanxi, 71006, China More Info
Study Coordinator
Contact
+862985323473
Shanghai Chest Hospital-Oncology department ( Site 2900)
Shanghai Shanghai, 20003, China More Info
Study Coordinator
Contact
15216769608
Fudan University Shanghai Cancer Center ( Site 2908)
Shanghai Shanghai, 20003, China More Info
Study Coordinator
Contact
18017312369
West China Hospital Sichuan University ( Site 2903)
Chengdu Sichuan, 61004, China More Info
Study Coordinator
Contact
+8618980602252
Sir Run Run Shaw Hospital-Medical Oncology ( Site 2906)
Hangzhou Zhejiang, 31001, China More Info
Study Coordinator
Contact
+8613605716662
Zhejiang Cancer Hospital-Oncology ( Site 2919)
Hangzhou Zhejiang, 31002, China More Info
Study Coordinator
Contact
13858182310
Vaasan Keskussairaala-Department of Clinical Oncology ( Site 0700)
Vaasa Pohjanmaa, 65130, Finland More Info
Study Coordinator
Contact
+358062136981
Oulun yliopistollinen sairaala-Oncology and Hematology ( Site 0702)
Oulu Pohjois-Pohjanmaa, 90220, Finland More Info
Study Coordinator
Contact
+35883153789
Turku University Hospital-The Department of Pulmonary Medicine ( Site 0701)
Turku Varsinais-Suomi, 20520, Finland More Info
Study Coordinator
Contact
+35823138709
Assistance Publique Hôpitaux de Marseille - Hôpital Nord ( Site 0805)
Marseille Bouches-du-Rhone, 13915, France More Info
Study Coordinator
Contact
+33491965924
CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 0800)
Toulouse Haute-Garonne, 31059, France More Info
Study Coordinator
Contact
+33561772233
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuyt-Unité d'oncologie thoracique et cutané
Limoges Haute-Vienne, 87042, France More Info
Study Coordinator
Contact
33555056892
Thoraxklinik-Heidelberg gGmbH-Studienzentrum Thoraxonkologie ( Site 0905)
Heidelberg Baden-Wurttemberg, 69126, Germany More Info
Study Coordinator
Contact
+4962213961301
Lungenfachklinik Immenhausen-Thoracic Oncology ( Site 0907)
Immenhausen Hessen, 34376, Germany More Info
Study Coordinator
Contact
056735010
LungenClinic Grosshansdorf-Onkologie ( Site 0903)
Grosshansdorf Schleswig-Holstein, 22927, Germany More Info
Study Coordinator
Contact
+49 4102 6012421
SRH Wald-Klinikum Gera-Lungenkrebszentrum ( Site 0900)
Gera Thuringen, 07548, Germany More Info
Study Coordinator
Contact
+49 365 828 7758
Errikos Dunant Hospital Center-Second Department of Oncology and Clinical Trials Unit ( Site 1002)
Athens Attiki, 115 2, Greece More Info
Study Coordinator
Contact
00302106972246
Sotiria Thoracic Diseases Hospital of Athens ( Site 1003)
Athens Attiki, 11527, Greece More Info
Study Coordinator
Contact
+302107700220
Metropolitan Hospital ( Site 1001)
Athens Attiki, 185 4, Greece More Info
Study Coordinator
Contact
00302104809339
European Interbalkan Medical Center ( Site 1000)
Thessaloniki , 57001, Greece More Info
Study Coordinator
Contact
00302310400368
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1105)
Kecskemét Bacs-Kiskun, 6000, Hungary More Info
Study Coordinator
Contact
+3676516719
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 1102)
Gyor Gyor-Moson-Sopron, 9024, Hungary More Info
Study Coordinator
Contact
36309758356
Torokbalint Tudogyogyintezet-Onkopulmonologiai Jarobeteg Centrum ( Site 1101)
Törökbálint Pest, 2045, Hungary More Info
Study Coordinator
Contact
36307005601
Somogy Megyei Kaposi Mór Oktató Kórház-Pulmonologiai Osztaly ( Site 1104)
Kaposvár Somogy, 7400, Hungary More Info
Study Coordinator
Contact
36703685838
Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1201)
Dublin , D09V2, Ireland More Info
Study Coordinator
Contact
01 8092875
Rambam Health Care Campus-Oncology ( Site 1301)
Haifa , 31096, Israel More Info
Study Coordinator
Contact
97247776700
Shaare Zedek Medical Center-Oncology ( Site 1300)
Jerusalem , 91031, Israel More Info
Study Coordinator
Contact
+972587040620
Sheba Medical Center-ONCOLOGY ( Site 1302)
Ramat Gan , 52656, Israel More Info
Study Coordinator
Contact
97235308495
Azienda Ospedaliera Dei Colli-U.O.C Pneumologia Oncologica DH PNL ONC ( Site 1402)
Naples Campania, 80131, Italy More Info
Study Coordinator
Contact
+390817064300
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1401)
Kurume Fukuoka, 830-0, Japan More Info
Study Coordinator
Contact
+81-942-35-3311
National Hospital Organization Hokkaido Cancer Center ( Site 3015)
Sapporo Hokkaido, 003-0, Japan More Info
Study Coordinator
Contact
+81-11-811-9111
Kanazawa University Hospital ( Site 3006)
Kanazawa Ishikawa, 920-8, Japan More Info
Study Coordinator
Contact
+81-76-265-2000
Kanagawa cancer center-Department of Thoracic Oncology ( Site 3004)
Yokohama Kanagawa, 241-8, Japan More Info
Study Coordinator
Contact
+81-45-520-2222
Sendai Kousei Hospital ( Site 3001)
Sendai Miyagi, 98008, Japan More Info
Study Coordinator
Contact
+81-22-222-6181
Niigata Cancer Center Hospital ( Site 3005)
Niigata-shi Niigata, 951-8, Japan More Info
Study Coordinator
Contact
+81-25-266-5111
Kansai Medical University Hospital ( Site 3009)
Hirakata Osaka, 57211, Japan More Info
Study Coordinator
Contact
+81-72-804-0101
Shizuoka Cancer Center ( Site 3007)
Nagaizumi Shizuoka, 411-8, Japan More Info
Study Coordinator
Contact
+81-55-989-5222
Japanese Foundation for Cancer Research ( Site 3003)
Koto Tokyo, 135-8, Japan More Info
Study Coordinator
Contact
+81-3-3520-0111
National Hospital Organization Kyushu Medical Center ( Site 3013)
Fukuoka , 810-8, Japan More Info
Study Coordinator
Contact
+81-92-852-0700
Okayama University Hospital ( Site 3011)
Okayama , 700-8, Japan More Info
Study Coordinator
Contact
+81-86-223-7151
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2800)
Hwasun Jeonranamdo, 58128, Korea, Republic of More Info
Study Coordinator
Contact
+82613797617
Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2801)
Deagu Taegu-Kwangyokshi, 41404, Korea, Republic of More Info
Study Coordinator
Contact
+82532002632
Chungnam national university hospital-Department of Internal Medicine ( Site 2802)
Daejeon Taejon-Kwangyokshi, 35015, Korea, Republic of More Info
Study Coordinator
Contact
+82422608584
Korea University Guro Hospital-Internal Medicine ( Site 2803)
Seoul , , Korea, Republic of More Info
Study Coordinator
Contact
+82226261914
Klaipeda University Hospital-Oncology chemotherapy ( Site 1502)
Klaipeda Klaipedos Miestas, 92288, Lithuania More Info
Study Coordinator
Contact
+37068713855
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1501)
Vilnius Vilniaus Miestas, 08406, Lithuania More Info
Study Coordinator
Contact
+37068613144
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1500)
Kaunas , LT-50, Lithuania More Info
Study Coordinator
Contact
+37061256473
Arké SMO S.A. de C.V. ( Site 0401)
Mexico Distrito Federal, 06700, Mexico More Info
Study Coordinator
Contact
+52 5555115833
Hospital Civil Fray Antonio Alcalde-Oncology ( Site 0407)
Guadalajara Jalisco, 44280, Mexico More Info
Study Coordinator
Contact
3322648799
Actualidad Basada en la Investigación del Cáncer-Lung Cancer ( Site 0403)
Guadalajara Jalisco, 44680, Mexico More Info
Study Coordinator
Contact
+52 (33) 1639-5372
iCan Oncology Center Centro Medico AVE ( Site 0406)
Monterrey Nuevo Leon, 64710, Mexico More Info
Study Coordinator
Contact
+52 8125558165
Centro de Investigacion Clinica de Oaxaca ( Site 0410)
Oaxaca , 68020, Mexico More Info
Study Coordinator
Contact
9516035559
Medische Centrum Leeuwarden ( Site 1619)
Leeuwarden Fryslan, 8934 , Netherlands More Info
Study Coordinator
Contact
+31582866666
Ziekenhuis Rijnstate ( Site 1606)
Arnhem Gelderland, 6815 , Netherlands More Info
Study Coordinator
Contact
+31880057790
Maastricht UMC+-Pulmonary disease ( Site 1602)
Maastricht Limburg, 6229 , Netherlands More Info
Study Coordinator
Contact
+31 (0)43 38 75051
Jeroen Bosch Hospital-Pulmonology ( Site 1605)
Den Bosch Noord-Brabant, 5223 , Netherlands More Info
Study Coordinator
Contact
+31735532463
Isala, locatie Zwolle-Poli Longziekten ( Site 1612)
Zwolle Overijssel, 8025 , Netherlands More Info
Study Coordinator
Contact
+31 (0)38 424 2456
Erasmus Medisch Centrum ( Site 1621)
Rotterdam Zuid-Holland, 3015 , Netherlands More Info
Study Coordinator
Contact
+31107030323
Martini Ziekenhuis ( Site 1618)
Groningen , 9728 , Netherlands More Info
Study Coordinator
Contact
+31620767110
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1709)
Siedlce Mazowieckie, 08-11, Poland More Info
Study Coordinator
Contact
0048698826497
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
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1703)
Przemysl Podkarpackie, 37-70, Poland More Info
Study Coordinator
Contact
4816 6775000
Szpital Specjalistyczny w Prabutach Spolka z o.o. ( Site 1706)
Prabuty Pomorskie, 82-55, Poland More Info
Study Coordinator
Contact
48503022396
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1707)
Bystra Slaskie, 43-36, Poland More Info
Study Coordinator
Contact
48334991801
Przychodnia Lekarska KOMED ( Site 1701)
Konin Wielkopolskie, 62-50, Poland More Info
Study Coordinator
Contact
48632428009
Hospital CUF Descobertas ( Site 1815)
Lisbon Lisboa, 1998-, Portugal More Info
Study Coordinator
Contact
+351210025200
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2102)
Madrid Madrid, Comunidad De, 28041, Spain More Info
Study Coordinator
Contact
+34914692313
H.R.U Málaga - Hospital General-Oncology ( Site 2104)
Málaga Malaga, 29011, Spain More Info
Study Coordinator
Contact
0034951291425
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2100)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
34934894158
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2103)
Sevilla , 41009, Spain More Info
Study Coordinator
Contact
+34955926578
Mount Vernon Hospital ( Site 2602)
Northwood Hillingdon, HA6 2, United Kingdom More Info
Study Coordinator
Contact
0203 826 2068

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

450

Study ID:

NCT05224141

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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