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Een onderzoek naar V940/Placebo + Pembrolizumab en chemotherapie bij gemetastaseerd plaveiselcelcarcinoom van de long (V940-013) (INTerpath-13)

9 november 2026 bijgewerkt door: Merck Sharp & Dohme LLC

Een fase 2, gerandomiseerde, dubbelblinde, placebo-gecontroleerde studie van V940 in combinatie met pembrolizumab en chemotherapie als eerstelijnsbehandeling voor deelnemers met gemetastaseerd plaveiseelcelcarcinoom van de long (INTerpath-013)

Researchers want to know if intismeran autogene (the study treatment) given with pembrolizumab and chemotherapy can treat metastatic treatment-naive squamous non-small cell lung cancer (NSCLC). Intismeran autogene is designed to help a person's immune system attack their specific cancer.

The goal of this study is to learn if people who receive intismeran autogene with pembrolizumab and chemotherapy live longer overall and without the cancer growing or spreading compared to people who receive placebo with pembrolizumab and chemotherapy. A placebo looks like the study treatment but has no study treatment in it. Using a placebo helps researchers better understand the effects of the study treatment.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

180

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Argentinië
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentinië, C1426ANZ
        • Werving
        • Instituto Alexander Fleming ( Site 0201)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +541132218956
      • Ciudad Autonoma de Buenos Aires., Buenos Aires, Argentinië, C1199ABB
        • Werving
        • Hospital Italiano de Buenos Aires ( Site 0200)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +541149590497
      • Mar del Plata, Buenos Aires, Argentinië, B7600FZO
        • Werving
        • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5492235937663
    • Buenos Aires F.D.
      • Caba., Buenos Aires F.D., Argentinië, C1430EGF
        • Werving
        • Clinica Adventista Belgrano ( Site 0206)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5491140141500
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentinië, S2000DSV
        • Werving
        • Fundacion Estudios Clinicos ( Site 0207)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +5493413168137
      • Rosario, Santa Fe Province, Argentinië, S2000DSV
        • Werving
        • Sanatorio Parque ( Site 0203)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +543874044942
  • Australië
    • New South Wales
      • Westmead, New South Wales, Australië, 2145
        • Werving
        • Westmead Hospital ( Site 0400)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +61298455555
    • Queensland
      • Woolloongabba, Queensland, Australië, 4102
        • Werving
        • Princess Alexandra Hospital ( Site 0403)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +61731762111
    • Western Australia
      • Nedlands, Western Australia, Australië, 6009
        • Werving
        • One Clinical Research ( Site 0402)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +6186279 9466
  • Chili
      • Antofagasta, Chili, 1263521
        • Werving
        • Bradford Hill Norte ( Site 0308)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 56442023631
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chili, 7500653
        • Werving
        • Centro de Estudios Clínicos SAGA ( Site 0307)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +56991612199
      • Santiago, Region M. de Santiago, Chili, 8420383
        • Werving
        • Bradfordhill ( Site 0301)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +56 2 29490970
      • Santiago, Region M. de Santiago, Chili, 7500921
        • Werving
        • Fundación Arturo López Pérez ( Site 0300)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 56224205098
  • Frankrijk
    • Cote-d Or
      • Dijon, Cote-d Or, Frankrijk, 21000
        • Werving
        • Centre Georges François Leclerc ( Site 0805)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33345348051
    • Pays de la Loire Region
      • Angers, Pays de la Loire Region, Frankrijk, 49055
        • Werving
        • Institut de Cancérologie de l'Ouest ( Site 0801)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33 (0)2.44 85 35 54
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, Frankrijk, 63001
        • Werving
        • CHU GABRIEL MONTPIED ( Site 0802)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +33473754440
  • Italië
      • Milan, Italië, 20132
        • Werving
        • Ospedale San Raffaele-Oncologia Medica ( Site 1002)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390226436633
      • Milan, Italië, 20133
        • Werving
        • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390223903829
      • Perugia, Italië, 06132
        • Werving
        • AO Santa Maria della Misericordia-Oncology Department ( Site 1005)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390755782661
      • Roma, Italië, 00168
        • Werving
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 00390630154277
    • Emilia-Romagna
      • Ravenna, Emilia-Romagna, Italië, 48121
        • Werving
        • Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +390544285247
  • Polen
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Polen, 60-569
        • Werving
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48616654242
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 02-781
        • Werving
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48225463066
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Polen, 37-700
        • Werving
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +48166775000
  • Spanje
      • Barcelona, Spanje, 08035
        • Werving
        • Hospital Universitari Vall d''Hebron ( Site 1310)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34 93 254 3450
      • Madrid, Spanje, 28034
        • Werving
        • Hospital Ramon y Cajal ( Site 1314)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34 91 336 82 63
      • Madrid, Spanje, 28040
        • Werving
        • Hospital Clinico San Carlos... ( Site 1313)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34 913303000
      • Seville, Spanje, 41009
        • Werving
        • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34 671560092
    • Barcelona
      • Hospitalet, Barcelona, Spanje, 08907
        • Werving
        • ICO L Hospitalet ( Site 1311)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +34 93 260 77 44
    • Cadiz
      • Jerez de la Frontera, Cadiz, Spanje, 11407
        • Werving
        • Hospital Jerez de la Frontera-UGC Oncología ( Site 1315)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 956 03 22 44
  • Taiwan
      • Taichung, Taiwan, 404
        • Werving
        • China Medical University Hospital ( Site 0606)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +886422052121
      • Tainan, Taiwan, 70403
        • Werving
        • National Cheng Kung University Hospital ( Site 0601)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +88662353535
      • Taipei, Taiwan, 104
        • Werving
        • Mackay Memorial Hospital ( Site 0604)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +886225433535
      • Taipei, Taiwan, 11217
        • Werving
        • Taipei Veterans General Hospital ( Site 0602)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +88628712121
      • Taipei, Taiwan, 106
        • Werving
        • National Taiwan University Cancer Center (NTUCC) ( Site 0600)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +886223220322
      • Taoyuan, Taiwan, 33305
        • Werving
        • Chang Gung Medical Foundation-Linkou Branch ( Site 0605)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +88633281200
  • Turkije (Türkiye)
      • Ankara, Turkije (Türkiye), 06230
        • Werving
        • Hacettepe Universitesi Tıp Fakultesi ( Site 1400)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +905436067759
      • Ankara, Turkije (Türkiye), 06800
        • Werving
        • Ankara Bilkent Şehir Hastanesi ( Site 1402)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +905384724282
      • Ankara, Turkije (Türkiye), 06520
        • Werving
        • Memorial Ankara Hastanesi ( Site 1401)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +9005321332009
      • Istanbul, Turkije (Türkiye), 34010
        • Werving
        • Koç Üniversitesi Hastanesi ( Site 1403)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +905369410661
  • Verenigde Staten
    • Florida
      • Tampa, Florida, Verenigde Staten, 33612
        • Werving
        • Moffitt Cancer Center ( Site 0021)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 813-745-7363
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48105
        • Werving
        • VA Ann Arbor Healthcare System ( Site 0019)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 734-769-7100
    • Missouri
      • St Louis, Missouri, Verenigde Staten, 63110
        • Werving
        • Washington University School of Medicine ( Site 0024)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 314-362-5000
    • New Jersey
      • Paramus, New Jersey, Verenigde Staten, 07652
        • Werving
        • Valley Health Systems - Ridgewood Campus ( Site 0010)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 201-634-5578
    • New York
      • Albany, New York, Verenigde Staten, 12206
        • Werving
        • New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 518-489-0044
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44195
        • Werving
        • Cleveland Clinic - Ohio ( Site 0016)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 216-445-7855
    • Oregon
      • Corvallis, Oregon, Verenigde Staten, 97330
        • Werving
        • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 541-768-4950
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37203
        • Werving
        • Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 615-961-9469
    • Texas
      • Austin, Texas, Verenigde Staten, 78745
        • Werving
        • Texas Oncology - Central/South Texas ( Site 8002)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 512-427-9400
    • Virginia
      • Fairfax, Virginia, Verenigde Staten, 22031
        • Werving
        • Virginia Cancer Specialists ( Site 0003)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 730-280-5390
    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Werving
        • Swedish Medical Center-Swedish Cancer Institute ( Site 0023)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 855-922-6237
  • Zuid -Korea
      • Seoul, Zuid -Korea, 05505
        • Werving
        • Asan Medical Center ( Site 0503)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82230103215
      • Seoul, Zuid -Korea, 06351
        • Werving
        • Samsung Medical Center ( Site 0502)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82234101132
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, Zuid -Korea, 10408
        • Werving
        • National Cancer Center ( Site 0504)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82319200114
      • Seongnam-si, Kyonggi-do, Zuid -Korea, 13620
        • Werving
        • Seoul National University Bundang Hospital ( Site 0500)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: +82317877071
    • North Chungcheong
      • Cheongju-si, North Chungcheong, Zuid -Korea, 28644
        • Werving
        • Chungbuk National University Hospital-Internal medicine ( Site 0501)
        • Contact:
          • Study Coordinator
          • Telefoonnummer: 043-269-6015

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

Inclusion Criteria include, but are not limited to:

  • Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted.
  • Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology
  • Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated
  • Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
  • Hepatitis B surface antigen (HBsAg) positive participants 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. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization
  • Has a life expectancy of at least 3 months
  • Has adequate organ function

Exclusion Criteria:

Exclusion Criteria include, but are not limited to:

  • Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV)
  • Has received prior systemic anticancer therapy for their metastatic NSCLC
  • 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. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
  • Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
  • Has received radiation therapy to the lung that is >30 gray within 6 months of start of study intervention
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
  • 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 (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
  • Has 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 severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has active infection requiring systemic therapy
  • Has a history of stem cell/solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intismeran Autogene + Pembrolizumab + Chemo

Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). Intismeran Autogene 1 mg intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses.

Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Intismeran Autogene 1 mg IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.
Biologisch: Intismeran Autogene

1 mg Intramuscular (IM) Injection

Andere namen:
  • mRNA-4157
  • V940
Biologisch: Pembrolizumab

200 mg IV Infusion

Andere namen:
  • MK-3475
  • KEYTRUDA®
Geneesmiddel: Carboplatin

Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion

Geneesmiddel: Paclitaxel

200 or 175 mg/m^2 IV Infusion

Geneesmiddel: Nab-paclitaxel

100 mg/m^2 IV Infusion
Experimenteel: Placebo + Pembrolizumab + Chemo

Induction phase: Participants receive pembrolizumab 400 mg intravenous (IV) infusion on Day 1 of a six week cycle plus a platinum doublet chemotherapy regimen (carboplatin area under the curve (AUC) 6 or 5 mg/mL/min IV infusion every 3 weeks (Q3W) × 2 doses combined either with paclitaxel 200 or 175 mg/m^2 IV infusion Q3W × 2 doses, OR with nab paclitaxel 100 mg/m^2 IV infusion weekly × 6 doses). Placebo intramuscular (IM) injection is administered on Days 1 and 22 of Cycle 2 Induction (Q3W) for up to 2 doses.

Maintenance phase: Participants receive pembrolizumab 400 mg IV infusion on Day 1 every 6 weeks (Q6W) for up to 15 doses. Placebo IM injection is administered on Days 1 and 22 (Q3W) for up to 7 doses during maintenance.
Biologisch: Pembrolizumab

200 mg IV Infusion

Andere namen:
  • MK-3475
  • KEYTRUDA®
Geneesmiddel: Carboplatin

Area Under the Curve (AUC) either 6 or 5 (mg/mL/min) IV Infusion

Geneesmiddel: Paclitaxel

200 or 175 mg/m^2 IV Infusion

Geneesmiddel: Nab-paclitaxel

100 mg/m^2 IV Infusion

Ander: Placebo

Placebo matched to Intismeran Autogene IM injection

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Progression Free Survival (PFS)
Tijdsspanne: Up to ~32 months

PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Up to ~32 months
Overall Survival (OS)
Tijdsspanne: Up to ~42 months

OS, defined as the time from randomization to death due to any cause. OS will be presented.
Up to ~42 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Overall Response Rate (ORR)
Tijdsspanne: Up to ~26 months

ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Up to ~26 months
Duration of Response (DOR)
Tijdsspanne: Up to ~42 months

For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to ~42 months
Number of Participants who Experience an Adverse Event (AE)
Tijdsspanne: Up to ~42 months

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.
Up to ~42 months
Number of Participants who Discontinue Study Intervention Due to an AE
Tijdsspanne: Up to ~24 months

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study intervention due to an AE will be presented.
Up to ~24 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merck Sharp & Dohme LLC

Medewerkers

ModernaTX, Inc.

Onderzoekers

  • Studie directeur: Medical Director, Merck Sharp & Dohme LLC

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 december 2025

Primaire voltooiing (Geschat)

2 juli 2029

Studie voltooiing (Geschat)

6 mei 2031

Studieregistratiedata

Eerst ingediend

24 oktober 2025

Eerst ingediend dat voldeed aan de QC-criteria

24 oktober 2025

Eerst geplaatst (Werkelijk)

28 oktober 2025

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

9 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • V940-013
  • V940-013 (Andere identificatie: MSD)
  • U1111-1318-2495 (Register-ID: UTN)
  • 2025-520902-37-00 (Register-ID: EU CT)
  • 2025 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren