Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01)

tiistai 15. syyskuuta 2026 päivittänyt: Merck Sharp & Dohme LLC

LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors

Researchers are looking for new ways to treat children with relapsed or refractory solid tumors:

  • Relapsed means the cancer came back after treatment
  • Refractory means the cancer did not respond (get smaller or go away) to treatment
  • Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids

The study treatment I-DXd (also known as MK-2400 or ifinatamab deruxtecan) is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The goals of this study are to learn:

  • About the safety of I-DXd and if children younger than 12 years old tolerate it
  • How many children who receive I-DXd have the cancer get smaller or go away

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

This study will have 2 parts: Part 1 will evaluate the safety and tolerability and determine the recommended dose for expansion (RDE) of I-DXd, followed by Part 2 an efficacy expansion.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

134

Vaihe

  • Vaihe 2
  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Belgia
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgia, 9000
        • Rekrytointi
        • UZ Gent ( Site 4428)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +32 9 332 16 53
  • Espanja
      • Barcelona, Espanja, 08035
        • Rekrytointi
        • Hospital Universitari Vall d Hebron ( Site 4716)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +34934893093
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Espanja, 8950
        • Rekrytointi
        • Hospital Sant Joan de Déu ( Site 4717)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +34671600093
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Espanja, 28009
        • Rekrytointi
        • Hospital Niño Jesús ( Site 4715)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +34915035900
  • Etelä -Korea
      • Seoul, Etelä -Korea, 03080
        • Rekrytointi
        • Seoul National University Hospital-Pediatrics ( Site 4972)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 82220723304
      • Seoul, Etelä -Korea, 05505
        • Rekrytointi
        • Asan Medical Center-Pediatrics - Pedicatric Oncology ( Site 4973)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 82230105994
  • Israel
      • Haifa, Israel, 3109601
        • Rekrytointi
        • Rambam Health Care Campus ( Site 4674)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +97247776755
      • Ramat Gan, Israel, 5265601
        • Rekrytointi
        • Sheba Medical Center ( Site 4675)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +97235302996
  • Ranska
    • Aquitaine
      • Bordeaux, Aquitaine, Ranska, 33076
        • Rekrytointi
        • Bordeaux University Hospital - Pellegrin ( Site 4105)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +33 5 56 79 56 79
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, Ranska, 44093
        • Rekrytointi
        • Centre Hospitalier Universitaire de Nantes - Hôpital Femme-Enfant-Adolescent Chu De Nantes ( Site 4104)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +33240087805
    • Rhone
      • Lyon, Rhone, Ranska, 69373
        • Rekrytointi
        • CENTRE LEON BERARD ( Site 4100)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +33469166572
  • Ruotsi
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Ruotsi, 416 85
        • Rekrytointi
        • Sahlgrenska Universitetssjukhuset ( Site 4634)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +46313435865
  • Tanska
    • Capital Region
      • Copenhagen, Capital Region, Tanska, DK-2100
        • Rekrytointi
        • Rigshospitalet ( Site 4467)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: +4535455002
  • Yhdysvallat
    • California
      • Los Angeles, California, Yhdysvallat, 90027
        • Rekrytointi
        • Children's Hospital Los Angeles ( Site 4006)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 323-361-2121
    • Colorado
      • Aurora, Colorado, Yhdysvallat, 80045
        • Rekrytointi
        • Children's Hospital Colorado-Center for Cancer and Blood Disorders ( Site 4016)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 720-777-6740
    • Iowa
      • Iowa City, Iowa, Yhdysvallat, 52242
        • Rekrytointi
        • University of Iowa Hospitals ( Site 4017)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 319-356-2296
    • Massachusetts
      • Boston, Massachusetts, Yhdysvallat, 02215
        • Rekrytointi
        • Dana Farber Cancer Center ( Site 4013)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 617-632-4580
    • Michigan
      • Grand Rapids, Michigan, Yhdysvallat, 49503
        • Rekrytointi
        • Corewell Health ( Site 4001)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 616-486-0746
    • New Jersey
      • New Brunswick, New Jersey, Yhdysvallat, 08901
        • Rekrytointi
        • Rutgers Cancer Institute of New Jersey ( Site 4008)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 732-235-2465
    • New York
      • New York, New York, Yhdysvallat, 10065
        • Rekrytointi
        • Memorial Sloan Kettering Cancer Center ( Site 4010)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 888-492-8401
      • Valhalla, New York, Yhdysvallat, 10595
        • Rekrytointi
        • New York Medical College ( Site 4023)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 914-614-4270
    • North Dakota
      • Fargo, North Dakota, Yhdysvallat, 58102
        • Rekrytointi
        • Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 4003)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 701-234-2000
    • Pennsylvania
      • Philadelphia, Pennsylvania, Yhdysvallat, 19104
        • Rekrytointi
        • Children's Hospital of Philadelphia (CHOP) ( Site 4021)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 267-425-5544
    • South Dakota
      • Sioux Falls, South Dakota, Yhdysvallat, 57105
        • Rekrytointi
        • Sanford Children's Hospital ( Site 4015)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 605-312-1000
    • Texas
      • Houston, Texas, Yhdysvallat, 77030
        • Rekrytointi
        • University of Texas M.D. Anderson Cancer Center ( Site 4007)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 713-792-5410
    • Utah
      • Salt Lake City, Utah, Yhdysvallat, 84113
        • Rekrytointi
        • Intermountain - Primary Children's Hospital ( Site 4014)
        • Ottaa yhteyttä:
          • Study Coordinator
          • Puhelinnumero: 801-662-4700

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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

  • In Part 1, participant has recurrent or relapsed, refractory solid tumors (excluding primary central nervous system (CNS)); and in Part 2, participant has recurrent or relapsed, refractory and histologically confirmed diagnosis of osteosarcoma (OST), neuroblastoma (NBL), rhabdomyosarcoma (RMS), or Wilms tumor (WT). All participants must meet the following criteria: Has documented radiological disease progression after at least 1 line of prior therapy in the locally advanced/metastatic setting and who has no satisfactory alternative treatment option (ie, is ineligible for other standard treatment regimens).
  • Is an individual of any sex/gender, ≥1 month to <12 years of age for Part 1 and ≥1 month to <18 years for Part 2 at the time of providing the informed consent or assent, as applicable
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.

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

  • Has clinically significant corneal disease
  • Has a history of cerebrovascular accident, transient ischemic attack, or another arterial thromboembolic event within 6 months before screening
  • Has uncontrolled or significant cardiovascular disease, including conduction abnormalities, hypertension, ischemic heart disease, heart failure, and peripheral vascular disease
  • Has any history of interstitial lung disease (ILD)/pneumonitis, irrespective of steroid use, except for a history of radiation pneumonitis that did not require steroids, current ILD, or Clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
  • Has clinically severe respiratory compromise resulting from intercurrent pulmonary illnesses
  • Has an active, known or suspected autoimmune disease.
  • Has history of solid organ transplant.
  • Has history of allogeneic stem cell transplant (SCT).
  • Has known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease/spinal cord compression. Participants with untreated and asymptomatic brain metastases or previously treated brain metastases may participate provided they are radiologically stable, (i.e, without evidence of progression) for at least 4 weeks
  • Has history of human immunodeficiency virus (HIV) infection.
  • Has known additional malignancy that is progressing or has required active treatment within the past 1 year.
  • Has active infection requiring systemic therapy
  • Has known hypersensitivity or contraindication to either the study intervention substance or inactive ingredients in the study intervention product
  • Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Ifinatamab Deruxtecan
Participants receive ifinatamab deruxtecan via intravenous (IV) infusion on day 1 of each 3-week cycle until discontinuation or progression
Biologinen: Ifinatamab Deruxtecan
IV infusion
Muut nimet:
  • DS-7300a
  • I-DXd
  • MK-2400

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience a Dose-limiting Toxicity (DLT)
Aikaikkuna: Cycle 1 (up to approximately 21 days); each cycle is 21 days
A DLT is any of a prespecified list of adverse events (AEs) that occur during Cycle 1 (up to 21 days) if attributed to the study treatment and not attributed to any other clearly identifiable cause. The percentage of participants who experience DLTs will be reported. Each cycle is 21 days.
Cycle 1 (up to approximately 21 days); each cycle is 21 days
Part 1: Number of Participants From ≥1 Month to <12 Years Who Experience One or More Adverse Events (AEs)
Aikaikkuna: Up to approximately 5 years
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Discontinue Study Intervention Due to an AE
Aikaikkuna: Up to approximately 5 years
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1: Number of Participants From ≥1 Month to <12 Years Who Receive Dose Modifications Due to AEs
Aikaikkuna: Up to approximately 5 years
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Objective Response Rate (ORR) for Participants with neuroblastoma (NBL), rhabdomyosarcoma (RMS), and Wilms tumor (WT)
Aikaikkuna: Up to approximately 5 years
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). The percentage of participants who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Success at 4 Months (DCS-4) for Participants with osteosarcoma (OST)
Aikaikkuna: Up to 4 Months
DCS-4 is defined as no occurrence of disease progression per disease specific criteria as assessed by investigator or death due to any cause by Month 4 following the first administration of study intervention for participants with OST. Participants who discontinue from study for any reason prior to completing the third post baseline (or at least 16 weeks) response assessments will be considered disease control failures.
Up to 4 Months

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Osa 1 ja osa 2: Yleinen eloonjääminen (OS)
Aikaikkuna: Jopa noin 5 vuotta
OS määritellään ajankohtana ensimmäisestä tutkimuksen hoidosta kuolemaan minkä tahansa syyn vuoksi.
Jopa noin 5 vuotta
Part 1 and Part 2: Duration of Response (DOR) For Participants With NBL, RMS, WT, or OST
Aikaikkuna: Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or 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 PD or death. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. DOR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Disease Control Rate (DCR) For Participants With NBL, RMS, WT, or OST
Aikaikkuna: Up to approximately 5 years
DCR is defined, per RECIST 1.1, as the percentage of participants who have a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) or Stable Disease (SD). SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm). Note: The appearance of one or more new lesions is also considered PD. The time from the first dose until the date of SD must be greater than or equal to 6 weeks. The DCR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Time to Response (TTR) For Participants With NBL, RMS, WT, or OST
Aikaikkuna: Up to approximately 5 years
For participants who demonstrate a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, TTR is defined as the time from the first dose to the first documented evidence of a CR or PR. The TTR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Progression-free Survival (PFS) For Participants With NBL, RMS, WT, or OST
Aikaikkuna: Up to approximately 5 years
PFS is defined as the time from randomization to the first documented PD or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Note: The appearance of one or more new lesions is also considered PD. PFS as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: ORR For participants with OST
Aikaikkuna: Up to approximately 5 years
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). The percentage of participants with OST who experience CR or PR as assessed by the investigator will be presented.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Experience an AE
Aikaikkuna: Up to approximately 5 years
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who experience AEs will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Discontinue Study Treatment Due to an AE
Aikaikkuna: Up to approximately 5 years
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who discontinue study treatment due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Number of Participants With NBL, RMS, WT, or OST Who Receive Dose Modification Due to an AE
Aikaikkuna: Up to approximately 5 years
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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The percentage of participants who receive dose modification due to an AE will be reported.
Up to approximately 5 years
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of I-Dxd
Aikaikkuna: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of I-Dxd
Aikaikkuna: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of I-Dxd
Aikaikkuna: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of I-Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Maximum Plasma Concentration (Cmax) of released drug payload (Dxd)
Aikaikkuna: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Cmax of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Area under the concentration time curve from Time 0 to the End of the Dosing Period (AUCtau) of Dxd
Aikaikkuna: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the AUCtau of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Plasma Trough Concentration (Ctrough) of Dxd
Aikaikkuna: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to determine the Ctrough of Dxd.
At designated timepoints (up to approximately 5 years)
Part 1 and Part 2: Number of Participants with antidrug antibodies (ADA) against I-Dxd
Aikaikkuna: At designated timepoints (up to approximately 5 years)
Blood samples will be collected at specified intervals to assess I-Dxd immunogenicity by determining the incidence of ADA of I-Dxd.
At designated timepoints (up to approximately 5 years)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Merck Sharp & Dohme LLC

Yhteistyökumppanit

Daiichi Sankyo

Tutkijat

  • Opintojohtaja: Medical Director, Merck Sharp & Dohme LLC

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Maanantai 6. heinäkuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Sunnuntai 17. elokuuta 2031

Opintojen valmistuminen (Arvioitu)

Sunnuntai 17. elokuuta 2031

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Maanantai 1. kesäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 1. kesäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Perjantai 5. kesäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 17. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 15. syyskuuta 2026

Viimeksi vahvistettu

Tiistai 1. syyskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 9999-01D
  • 2025 (Yhdysvaltain NIH-apuraha/sopimus: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • LIGHTBEAM-U01 (Muu tunniste: MSD)
  • U1111-1322-6561 (Rekisterin tunniste: UTN)
  • 2025-522339-32-00 (Rekisterin tunniste: EU CT)
  • MK-9999-01D (Muu tunniste: MSD)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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