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전이성 편평세포 비소세포폐암에서 V940/위약 + 펨브롤리주맙 및 화학요법에 대한 연구 (V940-013) (INTerpath-13)

2026년 11월 9일 업데이트: Merck Sharp & Dohme LLC

V940과 펨브롤리주맙 및 화학요법을 병용한 전이성 편평세포 비소세포폐암(NSCLC) 1차 치료 대상자를 위한 제2상, 무작위, 이중맹검, 위약 대조 연구(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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

180

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: Intismeran Autogene

1 mg Intramuscular (IM) Injection

다른 이름들:
  • mRNA-4157
  • V940
생물학적: Pembrolizumab

200 mg IV Infusion

다른 이름들:
  • MK-3475
  • 키트루다®
의약품: Carboplatin

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

의약품: Paclitaxel

200 or 175 mg/m^2 IV Infusion

의약품: Nab-paclitaxel

100 mg/m^2 IV Infusion
실험적: 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.
생물학적: Pembrolizumab

200 mg IV Infusion

다른 이름들:
  • MK-3475
  • 키트루다®
의약품: Carboplatin

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

의약품: Paclitaxel

200 or 175 mg/m^2 IV Infusion

의약품: Nab-paclitaxel

100 mg/m^2 IV Infusion

다른: Placebo

Placebo matched to Intismeran Autogene IM injection

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression Free Survival (PFS)
기간: 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)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Overall Response Rate (ORR)
기간: 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)
기간: 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)
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Merck Sharp & Dohme LLC

협력자

ModernaTX, Inc.

수사관

  • 연구 책임자: Medical Director, Merck Sharp & Dohme LLC

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 12월 12일

기본 완료 (추정된)

2029년 7월 2일

연구 완료 (추정된)

2031년 5월 6일

연구 등록 날짜

최초 제출

2025년 10월 24일

QC 기준을 충족하는 최초 제출

2025년 10월 24일

처음 게시됨 (실제)

2025년 10월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 9일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • V940-013
  • V940-013 (기타 식별자: MSD)
  • U1111-1318-2495 (레지스트리 식별자: UTN)
  • 2025-520902-37-00 (레지스트리 식별자: EU CT)
  • 2025 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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