En studie for å evaluere sikkerheten og effekten av MK-3120 hos deltakere med avanserte solide svulster (MK-3120-002)
En fase 1/2 åpen etikettstudie for å evaluere sikkerheten og effekten av MK-3120 hos deltakere med avanserte solide svulster
Researchers are looking for new ways to treat people with certain advanced solid tumors. Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids. The main goal of this study is to learn about the safety of MK-3120 and if people tolerate it.
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 7500653
- Rekruttering
- Centro de Estudios Clínicos SAGA ( Site 0033)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56991612199
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Santiago, Region M. de Santiago, Chile, 8330032
- Rekruttering
- Pontificia Universidad Catolica de Chile ( Site 0032)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56934331806
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Santiago, Region M. de Santiago, Chile, 8420383
- Rekruttering
- Bradford Hill Centro de Investigaciones Clinicas ( Site 0030)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56229490970
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Santiago, Region M. de Santiago, Chile, 7500921
- Rekruttering
- Fundación Arturo López Pérez ( Site 0031)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +56224205098
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Alabama
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Birmingham, Alabama, Forente stater, 35249
- Rekruttering
- The University of Alabama at Birmingham ( Site 1005)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 205-934-4199
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Florida
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Miami, Florida, Forente stater, 33136
- Rekruttering
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1003)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 305-243-5302
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
- Rekruttering
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 1009)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 551-996-5900
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Texas
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Austin, Texas, Forente stater, 78758
- Rekruttering
- NEXT Oncology ( Site 1010)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 737-610-5202
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Houston, Texas, Forente stater, 77054
- Rekruttering
- NEXT Oncology ( Site 1011)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 832-384-7912
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Irving, Texas, Forente stater, 75039
- Rekruttering
- NEXT Oncology ( Site 1012)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 972-893-8800
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Virginia
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Richmond, Virginia, Forente stater, 23219
- Rekruttering
- Virginia Commonwealth University ( Site 1008)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 804-828-7999
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Bouches-du-Rhone
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Marseille, Bouches-du-Rhone, Frankrike, 13273
- Rekruttering
- Institut Paoli Calmettes ( Site 0053)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33491223789
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Ille-et-Vilaine
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Rennes, Ille-et-Vilaine, Frankrike, 35000
- Aktiv, ikke rekrutterende
- Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer-Medical Oncology ( Site 0054)
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Nord
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Lille, Nord, Frankrike, 59000
- Rekruttering
- Centre Oscar Lambret ( Site 0051)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33320295959
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Val-de-Marne
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Villejuif, Val-de-Marne, Frankrike, 94800
- Rekruttering
- Gustave Roussy ( Site 0050)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33 (0)1 42 11 42 11
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Haifa, Israel, 3109601
- Aktiv, ikke rekrutterende
- Rambam Health Care Campus ( Site 0082)
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Petah Tikva, Israel, 4941492
- Aktiv, ikke rekrutterende
- Rabin Medical Center ( Site 0081)
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Ramat Gan, Israel, 5265601
- Aktiv, ikke rekrutterende
- Sheba Medical Center ( Site 0080)
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Osaka, Japan, 541-8567
- Rekruttering
- Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0191)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-6-6945-1181
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- Rekruttering
- National Cancer Center Hospital East ( Site 0190)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +81-4-7133-1111
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Tokyo
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Koto, Tokyo, Japan, 135-8550
- Aktiv, ikke rekrutterende
- Cancer Institute Hospital of JFCR ( Site 0192)
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100034
- Aktiv, ikke rekrutterende
- Peking University First Hospital ( Site 0180)
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 400030
- Aktiv, ikke rekrutterende
- Chongqing Cancer Hospital ( Site 0186)
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Hunan
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Changsha, Hunan, Kina, 410013
- Rekruttering
- Hunan Cancer Hospital ( Site 0181)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 073188651900
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Jilin
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Changchun, Jilin, Kina, 130021
- Aktiv, ikke rekrutterende
- The First Hospital of Jilin University ( Site 0185)
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Sichuan
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Chengdu, Sichuan, Kina, 610041
- Aktiv, ikke rekrutterende
- West China Hospital Sichuan University ( Site 0187)
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Gelderland
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Nijmegen, Gelderland, Nederland, 6525 GA
- Rekruttering
- Radboudumc ( Site 0091)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31 24 361 0353
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North Holland
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Amsterdam, North Holland, Nederland, 1066 CX
- Rekruttering
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0090)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31 20 512 2446
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Amsterdam, North Holland, Nederland, 1081HV
- Rekruttering
- Amsterdam UMC, locatie VUmc ( Site 0093)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31 20 444 4875
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South Holland
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Rotterdam, South Holland, Nederland, 3015 GD
- Rekruttering
- Erasmus Medisch Centrum ( Site 0092)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +31 10 704 0252
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 60-192
- Rekruttering
- Pratia Poznan ( Site 0105)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48506969916
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Polen, 30-727
- Rekruttering
- Pratia MCM Krakow ( Site 0106)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48122954100
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 02-781
- Rekruttering
- Narodowy Instytut Onkologii ( Site 0100)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48225463381
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West Pomeranian Voivodeship
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Koszalin, West Pomeranian Voivodeship, Polen, 75-581
- Rekruttering
- Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie ( Site 0104)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +48943488930
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Málaga, Spania, 29016
- Rekruttering
- Hospital Universitario Virgen de la Victoria ( Site 0114)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34951032508
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, Spania, 08908
- Rekruttering
- Institut Català d'Oncologia - L'Hospitalet ( Site 0113)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34932603261
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Catalonia
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Barcelona, Catalonia, Spania, 08036
- Aktiv, ikke rekrutterende
- HOSPITAL CLÍNIC DE BARCELONA ( Site 0112)
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Spania, 28040
- Rekruttering
- Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 0111)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +34915504800x2805
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Seoul, Sør -Korea, 03080
- Rekruttering
- Seoul National University Hospital ( Site 0150)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82220720795
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Seoul, Sør -Korea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System ( Site 0151)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 82-2-393-3652
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Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center ( Site 0153)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 02-3010-3266
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Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center ( Site 0152)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82234103438
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Tainan, Taiwan, 704
- Aktiv, ikke rekrutterende
- National Cheng Kung University Hospital ( Site 0161)
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Taipei, Taiwan, 10002
- Aktiv, ikke rekrutterende
- National Taiwan University Hospital ( Site 0160)
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Tainan
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Tainan, Tainan, Taiwan, 71004
- Aktiv, ikke rekrutterende
- Chi Mei Medical Center ( Site 0162)
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Ankara, Tyrkia (Türkiye), 6230
- Rekruttering
- Hacettepe Universite Hastaneleri ( Site 0130)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +90 312 305 43 30
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Ankara, Tyrkia (Türkiye), 06620
- Rekruttering
- Ankara University Health Practice and Research Hospitals ( Site 0134)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: +90 312 595 71 39
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Istanbul, Tyrkia (Türkiye), 34010
- Rekruttering
- Koc University, School of Medicine ( Site 0133)
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Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0212 467 87 00.
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Ankara
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Çankaya, Ankara, Tyrkia (Türkiye), 06800
- Aktiv, ikke rekrutterende
- Ankara Bilkent Şehir Hastanesi. ( Site 0131)
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments
- If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART)
- If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
- If hepatitis C virus (HCV) infected, must have undetectable HCV viral load
Exclusion Criteria:
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
- Has uncontrolled significant cardiovascular disease or cerebrovascular disease
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
- Is HIV-positive and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Known additional malignancy that is progressing or has required active treatment within the past 2 years
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active infection requiring systemic therapy, with exceptions
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
- Has HBV or HCV infection
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
|
Eksperimentell: Arm 1 Dose level 1
Participants receive MK-3120 at dose level 1 as per the schedule specified in the arm. |
IV infusion
Andre navn:
|
|
Eksperimentell: Arm 2 Dose level 2
Participants receive MK-3120 at dose level 2 as per the schedule specified in the arm. |
IV infusion
Andre navn:
|
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Experience an Adverse Event (AE)
Tidsramme: Up to approximately 19 months
|
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience at least one AE will be presented. |
Up to approximately 19 months
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
Tidsramme: Up to approximately 18 months
|
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented. |
Up to approximately 18 months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator
Tidsramme: Up to approximately 48 months
|
ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) as assessed by the investigator per RECIST 1.1. |
Up to approximately 48 months
|
Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Etterforskere
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
Andre studie-ID-numre
- 3120-002
- U1111-1311-1904 (Registeridentifikator: UTN)
- 2024-516817-19-00 (Registeridentifikator: EU CT)
- jRCT2031250198 (Registeridentifikator: Japan Registry of Clinical Trial (jRCT))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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