A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)

THE STUDY

About this study

Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery.

People with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer.

The main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.

Full official title

A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

PARTICIPATION

Who may participate

Minimum age: 18 Years
Maximum age: Not reported
Sex eligibility: All sexes
Healthy volunteers: Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size \>2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology
* Has undergone a complete surgical resection of the primary NSCLC
* Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC
* Has provided a tissue sample from recent surgery along with the required blood sample
* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)
* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization
* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs
* Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia
* HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
* Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has active infection requiring systemic therapy other than those permitted in protocol
* Has history of stem cell/solid organ transplant
* Participants who have not adequately recovered from major surgery or have ongoing surgical complications

NEAR YOU

Study locations worldwide

119 sites

Check the individual site’s status and contact the listed study team for current availability.

UC Davis Comprehensive Cancer Center ( Site 3204)

Recruiting

Sacramento, California, 95817, United States

Site contacts (1)

Study CoordinatorContactPhone: 916-734-5959

University of Colorado Cancer Center ( Site 3268)

Recruiting

Aurora, Colorado, 80045, United States

Site contacts (1)

Study CoordinatorContactPhone: 720-848-0300

Smilow Cancer Center at Yale-New Haven ( Site 3253)

Recruiting

New Haven, Connecticut, 06511, United States

Site contacts (1)

Study CoordinatorContactPhone: 203-688-4242

UF Health Cancer Center ( Site 3257)

Recruiting

Gainesville, Florida, 32610, United States

Site contacts (1)

Study CoordinatorContactPhone: 352-273-8010

Illinois Cancer Care ( Site 7000)

Recruiting

Peoria, Illinois, 61615, United States

Site contacts (1)

Study CoordinatorContactPhone: 309-240-6040

Washington University School of Medicine ( Site 3279)

Recruiting

St Louis, Missouri, 63110, United States

Site contacts (1)

Study CoordinatorContactPhone: 314-362-5000

Billings Clinic ( Site 3255)

Recruiting

Billings, Montana, 59101, United States

Site contacts (1)

Study CoordinatorContactPhone: 406-435-7480

NHO Revive Research Institute, LLC ( Site 3218)

Recruiting

Lincoln, Nebraska, 68506, United States

Site contacts (1)

Study CoordinatorContactPhone: 402-484-4900

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)

Recruiting

Reno, Nevada, 89502, United States

Site contacts (1)

Study CoordinatorContactPhone: 775-982-4000

New York Oncology Hematology, P.C. ( Site 9000)

Recruiting

Albany, New York, 12206, United States

Site contacts (1)

Study CoordinatorContactPhone: 518-489-0044

SUNY Upstate Medical University ( Site 3270)

Recruiting

Syracuse, New York, 13210, United States

Site contacts (1)

Study CoordinatorContactPhone: 315-464-8237

White Plains Hospital ( Site 3213)

Recruiting

White Plains, New York, 10601, United States

Site contacts (1)

Study CoordinatorContactPhone: 914-849-7500

Charles George VA Medical Center ( Site 3233)

Recruiting

Asheville, North Carolina, 28805, United States

Site contacts (1)

Study CoordinatorContactPhone: 828-298-7911

UNC Lineberger Comprehensive Cancer Center ( Site 3250)

Recruiting

Chapel Hill, North Carolina, 27514, United States

Site contacts (1)

Study CoordinatorContactPhone: 919-966-4432

WakeMed Raleigh Campus ( Site 3214)

Recruiting

Raleigh, North Carolina, 27610, United States

Site contacts (1)

Study CoordinatorContactPhone: 919-350-2873

Sanford Fargo Medical Center ( Site 3236)

Recruiting

Fargo, North Dakota, 58102, United States

Site contacts (1)

Study CoordinatorContactPhone: 701-234-7563

Altru Health System ( Site 3254)

Recruiting

Grand Forks, North Dakota, 58201, United States

Site contacts (1)

Study CoordinatorContactPhone: 701-780-5400

Perelman Center for Advanced Medicine ( Site 3205)

Recruiting

Philadelphia, Pennsylvania, 19104, United States

Site contacts (1)

Study CoordinatorContactPhone: 267-275-3770

Sanford Cancer Center ( Site 3266)

Recruiting

Sioux Falls, South Dakota, 57104, United States

Site contacts (1)

Study CoordinatorContactPhone: 605-312-3250

Avera Cancer Institute ( Site 3209)

Recruiting

Sioux Falls, South Dakota, 57105, United States

Site contacts (1)

Study CoordinatorContactPhone: 605-322-3000

The University of Tennessee Medical Center ( Site 3223)

Recruiting

Knoxville, Tennessee, 37920, United States

Site contacts (1)

Study CoordinatorContactPhone: 865-305-8780

Hematology Oncology Associates of Fredericksburg ( Site 3275)

Recruiting

Fredericksburg, Virginia, 22408, United States

Site contacts (1)

Study CoordinatorContactPhone: 540-371-0079

West Virginia University ( Site 3237)

Recruiting

Morgantown, West Virginia, 26506, United States

Site contacts (1)

Study CoordinatorContactPhone: 304-598-4500

Gundersen Health System ( Site 3200)

Recruiting

La Crosse, Wisconsin, 54601, United States

Site contacts (1)

Study CoordinatorContactPhone: 608-775-2385

Royal North Shore Hospital ( Site 0502)

Recruiting

St Leonards, New South Wales, 2065, Australia

Site contacts (1)

Study CoordinatorContactPhone: +61299267111

Princess Alexandra Hospital ( Site 0503)

Recruiting

Brisbane, Queensland, 4102, Australia

Site contacts (1)

Study CoordinatorContactPhone: 0731762111

One Clinical Research ( Site 0501)

Recruiting

Nedlands, Western Australia, 6009, Australia

Site contacts (1)

Study CoordinatorContactPhone: +61410565868

Hospital de Clínicas de Passo Fundo ( Site 3601)

Recruiting

Pasos Fundo, Rio Grande do Sul, 99010-260, Brazil

Site contacts (1)

Study CoordinatorContactPhone: +5554981271411

Hospital Sírio Libanês ( Site 3611)

Recruiting

São Paulo, 01308-060, Brazil

Site contacts (1)

Study CoordinatorContactPhone: +5511994125414

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)

Recruiting

Hamilton, Ontario, L8V 5C2, Canada

Site contacts (1)

Study CoordinatorContactPhone: 905-387-9495

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)

Recruiting

Kingston, Ontario, K7L 2V7, Canada

Site contacts (1)

Study CoordinatorContactPhone: 6135496666

The Ottawa Hospital Cancer Centre ( Site 2508)

Recruiting

Ottawa, Ontario, K1H 8L6, Canada

Site contacts (1)

Study CoordinatorContactPhone: 613-722-7000

Centre Hospitalier de l'Université de Montréal ( Site 2501)

Recruiting

Montreal, Quebec, H2X 3E4, Canada

Site contacts (1)

Study CoordinatorContactPhone: 5148908000x26832

Clínica MEDS La Dehesa ( Site 3708)

Recruiting

Lo Barnechea, Region M. de Santiago, 7691236, Chile

Site contacts (1)

Study CoordinatorContactPhone: +56229015945

Centro de Oncología de Precisión ( Site 3706)

Recruiting

Santiago, Region M. de Santiago, 7500000, Chile

Site contacts (1)

Study CoordinatorContactPhone: +56225189885

FALP-UIDO ( Site 3701)

Recruiting

Santiago, Region M. de Santiago, 7500921, Chile

Site contacts (1)

Study CoordinatorContactPhone: +56226062331

Bradfordhill-Clinical Area ( Site 3700)

Recruiting

Santiago, Region M. de Santiago, 8420383, Chile

Site contacts (1)

Study CoordinatorContactPhone: +56 229490970

ONCOCENTRO APYS-ACEREY ( Site 3704)

Recruiting

Viña del Mar, Valparaiso, 2520598, Chile

Site contacts (1)

Study CoordinatorContactPhone: +56323320860

Bradford Hill Norte ( Site 3705)

Recruiting

Antofagasta, 2520598, Chile

Site contacts (1)

Study CoordinatorContactPhone: +5644232023631

Promotora Médica Las Américas S.A. ( Site 3800)

Recruiting

Medellín, Antioquia, 050021, Colombia

Site contacts (1)

Study CoordinatorContactPhone: +570343421010

Clinica Somer ( Site 3802)

Recruiting

Rionegro, Antioquia, 054040, Colombia

Site contacts (1)

Study CoordinatorContactPhone: +5746052626

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 3806)

Recruiting

Bogotá, Bogota D.C., 110131, Colombia

Site contacts (1)

Study CoordinatorContactPhone: +573219198898

Clínica Universitaria Colombia ( Site 3803)

Recruiting

Bogotá, Bogota D.C., 111321, Colombia

Site contacts (1)

Study CoordinatorContactPhone: +573016254437

Instituto Nacional De Cancerologia-Oncología Clínica ( Site 3804)

Recruiting

Bogota, Cundinamarca, 111151, Colombia

Site contacts (1)

Study CoordinatorContactPhone: +573108658288

Instituto Médico de Alta Tecnología S.A.S - IMAT S.A.S ( Site 3801)

Recruiting

Montería, Departamento de Córdoba, 230002, Colombia

Site contacts (1)

Study CoordinatorContactPhone: +576047862333

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 2605)

Recruiting

Rennes, Brittany Region, 35000, France

Site contacts (1)

Study CoordinatorContactPhone: +33299283738

Hôpital Foch ( Site 2604)

Recruiting

Suresnes, Hauts-de-Seine, 92150, France

Site contacts (1)

Study CoordinatorContactPhone: +33146252000

CHU GABRIEL MONTPIED ( Site 2608)

Recruiting

Clermont-Ferrand, Puy-de-Dome, 63000, France

Site contacts (1)

Study CoordinatorContactPhone: +33473754440

Thoraxklinik-Heidelberg gGmbH ( Site 2703)

Recruiting

Heidelberg, Baden-Wurttemberg, 69126, Germany

Site contacts (1)

Study CoordinatorContactPhone: +4962213960

Augusta-Kranken-Anstalt ( Site 2702)

Recruiting

Bochum, North Rhine-Westphalia, 44791, Germany

Site contacts (1)

Study CoordinatorContactPhone: 00492345172453

SRH Wald-Klinikum Gera ( Site 2700)

Recruiting

Gera, Thuringia, 07548, Germany

Site contacts (1)

Study CoordinatorContactPhone: +493658280

Errikos Dunant Hospital Center ( Site 5004)

Recruiting

Athens, Attica, 115 26, Greece

Site contacts (1)

Study CoordinatorContactPhone: +302107470960

THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 5001)

Recruiting

Athens, Attica, 115 27, Greece

Site contacts (1)

Study CoordinatorContactPhone: +302107700220

University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5003)

Recruiting

Athens, Attica, 124 62, Greece

Site contacts (1)

Study CoordinatorContactPhone: 302105832549

European Interbalkan Medical Center-Oncology Department ( Site 5000)

Recruiting

Thessaloniki, 570 01, Greece

Site contacts (1)

Study CoordinatorContactPhone: +302310400213

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)

Recruiting

Pécs, Baranya, 7623, Hungary

Site contacts (1)

Study CoordinatorContactPhone: +36 72 535890

Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409)

Recruiting

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Site contacts (1)

Study CoordinatorContactPhone: +36304835188

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)

Recruiting

Kecskemét, Bács-Kiskun county, 6000, Hungary

Site contacts (1)

Study CoordinatorContactPhone: +3676516700/6719

Nograd Varmegyei Szent Lazar Korhaz ( Site 4410)

Recruiting

Salgótarján, Nógrád megye, 3100, Hungary

Site contacts (1)

Study CoordinatorContactPhone: +3632522000

Reformatus Pulmonologiai Centrum ( Site 4403)

Recruiting

Törökbálint, Pest County, 2045, Hungary

Site contacts (1)

Study CoordinatorContactPhone: +36 23 511 570

Országos Onkológiai Intézet ( Site 4405)

Recruiting

Budapest, 1122, Hungary

Site contacts (1)

Study CoordinatorContactPhone: +3612248600

Rambam Health Care Campus ( Site 3303)

Recruiting

Haifa, 3109601, Israel

Site contacts (1)

Study CoordinatorContactPhone: +97247772688

Shaare Zedek Medical Center ( Site 3301)

Recruiting

Jerusalem, 9103102, Israel

Site contacts (1)

Study CoordinatorContactPhone: +97226555999

Hadassah Medical Center ( Site 3305)

Recruiting

Jerusalem, 9112001, Israel

Site contacts (1)

Study CoordinatorContactPhone: +97226777333

Meir medical center ( Site 3306)

Recruiting

Kfar Saba, 4428164, Israel

Site contacts (1)

Study CoordinatorContactPhone: +97297472555

Rabin Medical Center ( Site 3304)

Recruiting

Petah Tikva, 4941492, Israel

Site contacts (1)

Study CoordinatorContactPhone: 972-3-9378086

Sheba Medical Center ( Site 3302)

Recruiting

Ramat Gan, 5265601, Israel

Site contacts (1)

Study CoordinatorContactPhone: +97235307096

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII ( Site 2804)

Recruiting

Bergamo, Lombardy, 24127, Italy

Site contacts (1)

Study CoordinatorContactPhone: +390352673694

Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800)

Recruiting

Milan, Lombardy, 20133, Italy

Site contacts (1)

Study CoordinatorContactPhone: +390223903816

Azienda Ospedaliera Universitaria Careggi ( Site 2806)

Recruiting

Florence, Tuscany, 50134, Italy

Site contacts (1)

Study CoordinatorContactPhone: 00390557947298

AO Santa Maria della Misericordia ( Site 2809)

Recruiting

Perugia, Umbria, 06132, Italy

Site contacts (1)

Study CoordinatorContactPhone: +390755782661

Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)

Recruiting

Novara, 28100, Italy

Site contacts (1)

Study CoordinatorContactPhone: 003903213732296

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2801)

Recruiting

Roma, 00168, Italy

Site contacts (1)

Study CoordinatorContactPhone: +390630155202

Hospital of the University of Occupational and Environmental Health, Japan ( Site 5516)

Recruiting

Kitakyushu, Fukuoka, 807-8556, Japan

Site contacts (1)

Study CoordinatorContactPhone: +81-93-603-1611

Fukushima Medical University Hospital ( Site 5501)

Recruiting

Fukushima, 960-1295, Japan

Site contacts (1)

Study CoordinatorContactPhone: +81-24-547-1111

Yamagata University Hospital ( Site 5500)

Recruiting

Yamagata, 990-9585, Japan

Site contacts (1)

Study CoordinatorContactPhone: +81-23-633-1122

Ziekenhuis St. Jansdal ( Site 4800)

Recruiting

Harderwijk, Gelderland, 3844 DG, Netherlands

Site contacts (1)

Study CoordinatorContactPhone: +31341463742

Radboudumc ( Site 4806)

Recruiting

Nijmegen, Gelderland, 6525 GA, Netherlands

Site contacts (1)

Study CoordinatorContactPhone: +31243610353

Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 4809)

Recruiting

Amsterdam, North Holland, 1066 CX, Netherlands

Site contacts (1)

Study CoordinatorContactPhone: +31205129111

Elisabeth-TweeSteden Ziekenhuis ( Site 4801)

Recruiting

Tilburg, North Holland, 5022 GC, Netherlands

Site contacts (1)

Study CoordinatorContactPhone: +31132213101

Isala, locatie Zwolle ( Site 4804)

Recruiting

Zwolle, Overijssel, 8025 AB, Netherlands

Site contacts (1)

Study CoordinatorContactPhone: 088-6243254

Frisius Medisch Centrum ( Site 4808)

Recruiting

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Site contacts (1)

Study CoordinatorContactPhone: +31503614679

Meander Medisch Centrum ( Site 4802)

Recruiting

Amersfoort, Utrecht, 3813 TZ, Netherlands

Site contacts (1)

Study CoordinatorContactPhone: +31338507843

University Medical Center Groningen ( Site 4807)

Recruiting

Groningen, 9713 GZ, Netherlands

Site contacts (1)

Study CoordinatorContactPhone: +31503614679

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)

Recruiting

Poznan, Greater Poland Voivodeship, 60-569, Poland

Site contacts (1)

Study CoordinatorContactPhone: +48616654242

Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 4200)

Recruiting

Warsaw, Masovian Voivodeship, 01-138, Poland

Site contacts (1)

Study CoordinatorContactPhone: +48224312360

IP Clinic ( Site 4204)

Recruiting

Lodz, Łódź Voivodeship, 90-752, Poland

Site contacts (1)

Study CoordinatorContactPhone: +48 48 42 208 97 98

Wojewodzki Szpital Specjalistyczny im. sw. Rafala w Czerwonej Gorze ( Site 4206)

Recruiting

Chęciny, Świętokrzyskie Voivodeship, 26-060, Poland

Site contacts (1)

Study CoordinatorContactPhone: +48413465545wew256

National Cancer Center ( Site 5202)

Recruiting

Goyang-si, Kyonggi-do, 10408, South Korea

Site contacts (1)

Study CoordinatorContactPhone: +82-31-920-1676

Seoul National University Bundang Hospital ( Site 5200)

Recruiting

Seongnam-si, Kyonggi-do, 13620, South Korea

Site contacts (1)

Study CoordinatorContactPhone: +82317877071

The Catholic University Of Korea St. Vincent's Hospital ( Site 5203)

Recruiting

Suwon, Kyonggi-do, 16247, South Korea

Site contacts (1)

Study CoordinatorContactPhone: 82-31-249-7744

Chungbuk National University Hospital ( Site 5201)

Recruiting

Cheongju-si, North Chungcheong, 28644, South Korea

Site contacts (1)

Study CoordinatorContactPhone: +82432696015

Asan Medical Center ( Site 5205)

Recruiting

Seoul, 05505, South Korea

Site contacts (1)

Study CoordinatorContactPhone: +82230103214

Samsung Medical Center ( Site 5206)

Recruiting

Seoul, 06351, South Korea

Site contacts (1)

Study CoordinatorContactPhone: +82-2-3410-1132

ICO - Hospital Duran i Reynals ( Site 0301)

Recruiting

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Site contacts (1)

Study CoordinatorContactPhone: +34932607744

Hospital de Cruces ( Site 0308)

Recruiting

Barakaldo, Bizkaia, 48903, Spain

Site contacts (1)

Study CoordinatorContactPhone: +34946006399

Hospital Universitari Vall d'Hebron ( Site 0300)

Recruiting

Barcelona, Catalonia, 08035, Spain

Site contacts (1)

Study CoordinatorContactPhone: +34932746000

Hospital Virgen de la Victoria ( Site 0309)

Recruiting

Málaga, Malaga, 29010, Spain

Site contacts (1)

Study CoordinatorContactPhone: +34671594566

Hospital Universitario de Badajoz ( Site 0305)

Recruiting

Badajoz, 06006, Spain

Site contacts (1)

Study CoordinatorContactPhone: +34924218040

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)

Recruiting

Madrid, 28009, Spain

Site contacts (1)

Study CoordinatorContactPhone: +34915868115

Hospital Clinico San Carlos ( Site 0303)

Recruiting

Madrid, 28040, Spain

Site contacts (1)

Study CoordinatorContactPhone: +34913303000

Hospital Universitario Virgen Macarena ( Site 0306)

Recruiting

Seville, 41007, Spain

Site contacts (1)

Study CoordinatorContactPhone: +34955008000

Hospital General de Valencia ( Site 0304)

Recruiting

Valencia, 46014, Spain

Site contacts (1)

Study CoordinatorContactPhone: +34963187527

Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)

Recruiting

Kaohsiung City, 83301, Taiwan

Site contacts (1)

Study CoordinatorContactPhone: +886 7-7317123

China Medical University Hospital ( Site 5303)

Recruiting

Taichung, 40447, Taiwan

Site contacts (1)

Study CoordinatorContactPhone: +886422052121

Taichung Veterans General Hospital ( Site 5301)

Recruiting

Taichung, 407, Taiwan

Site contacts (1)

Study CoordinatorContactPhone: +886423592525

National Cheng Kung University Hospital ( Site 5300)

Recruiting

Tainan, 704, Taiwan

Site contacts (1)

Study CoordinatorContactPhone: +88662353535

Taipei Medical University Hospital ( Site 5305)

Recruiting

Taipei, 110, Taiwan

Site contacts (1)

Study CoordinatorContactPhone: +886227372181

Adana Medical Park Seyhan Hastanesi ( Site 4302)

Recruiting

Adana, 1140, Turkey (Türkiye)

Site contacts (1)

Study CoordinatorContactPhone: +905056166338

Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)

Recruiting

Ankara, 6230, Turkey (Türkiye)

Site contacts (1)

Study CoordinatorContactPhone: +905523567926

Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi ( Site 4309)

Recruiting

Ankara, 6280, Turkey (Türkiye)

Site contacts (1)

Study CoordinatorContactPhone: +905360653456

Ankara Bilkent Sehir Hastanesi ( Site 4306)

Recruiting

Ankara, 6800, Turkey (Türkiye)

Site contacts (1)

Study CoordinatorContactPhone: +903125526000

İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)

Recruiting

Istanbul, 34010, Turkey (Türkiye)

Site contacts (1)

Study CoordinatorContactPhone: +90549872864

KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 4308)

Recruiting

Istanbul, 34890, Turkey (Türkiye)

Site contacts (1)

Study CoordinatorContactPhone: +905367197395

Ege Universitesi Hastanesi ( Site 4301)

Recruiting

Izmir, 35100, Turkey (Türkiye)

Site contacts (1)

Study CoordinatorContactPhone: 905322202675

Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 4304)

Recruiting

Kayseri, 38039, Turkey (Türkiye)

Site contacts (1)

Study CoordinatorContactPhone: +905388731881

St Bartholomew's Hospital ( Site 0400)

Recruiting

London, London, City of, EC1A 7BE, United Kingdom

Site contacts (1)

Study CoordinatorContactPhone: 0203 765 8544

Charing Cross Hospital ( Site 0407)

Recruiting

London, London, City of, W6 8RF, United Kingdom

Site contacts (1)

Study CoordinatorContactPhone: 020 331 10291

Singleton Hospital ( Site 0403)

Recruiting

Swansea, SA2 8QA, United Kingdom

Site contacts (1)

Study CoordinatorContactPhone: 01792205666

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

IntismeranBiological

IM injection

Study groups: Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa, Arm B: Intismeran

Other names: V940, mRNA-4157

Pembrolizumab coformulated with berahyaluronidase alfaBiological

SC injection

Study groups: Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa

Other names: MK-3475A

PlaceboOther

IM injection

Study groups: Arm C: Placebo

Study groups

Arm A: Intismeran + Pembrolizumab with Berahyaluronidase AlfaExperimental

Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.

Interventions: Biological: Intismeran, Biological: Pembrolizumab coformulated with berahyaluronidase alfa

Arm B: IntismeranExperimental

Participants will receive intismeran 1 mg via IM injection.

Interventions: Biological: Intismeran

Arm C: PlaceboPlacebo comparator

Participants will receive dose-matched placebo via IM injection.

Interventions: Other: Placebo

RESEARCH DETAILS

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Study model: Parallel
Masking: Triple
Enrolment: 876 participants · Estimated
Who is masked: Participant, Investigator, Outcomes assessor

Masking details

Arm A - Open Label Arms B and C - Double Blind

TIMELINE & MEASURES

Dates and outcomes

Study started: 4 May 2026 · Actual
Primary completion: 22 Aug 2034 · Estimated
Study completion: 11 May 2038 · Estimated
First registered: 7 Apr 2026 · Actual
Last registry update: 19 Oct 2026 · Actual
Status last verified: Oct 2026

Primary outcomes (1)

Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C

DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.

Time frame: Up to approximately 98 months

Secondary outcomes (8)

DFS as Assessed by BICR

DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.

Time frame: Up to approximately 98 months

Distant Metastasis-Free Survival (DMFS)

DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis by BICR or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.

Time frame: Up to approximately 111 months

Overall Survival (OS)

OS is defined as the time from randomization to death due to any cause.

Time frame: Up to approximately 123 months

Number Participants Who Experience an Adverse Events (AE)

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.

Time frame: Up to approximately 144 months

Number of Participants Who Discontinue Study Treatment Due to an AE

Time frame: Up to approximately 144 months

Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score

EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.

Time frame: Baseline and up to approximately 36 months

Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented.

Time frame: Baseline and up to approximately 36 months

Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score

EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates a worse level of role functioning. The change from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented.

Time frame: Baseline and up to approximately 36 months

STUDY TEAM

Sponsor and contacts

Lead sponsor: Merck Sharp & Dohme LLC
Sponsor type: Industry
Collaborators: ModernaTX, Inc.
Organisation study ID: V940-014

Central study contacts

Toll Free NumberContactPhone: 1-888-577-8839Email: Trialsites@msd.com

Study officials

Medical DirectorStudy director · Merck Sharp & Dohme LLC

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.