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Et studie af Precemtabart Tocentecan med eller uden Bevacizumab sammenlignet med Trifluridin/Tipiracil plus Bevacizumab hos deltagere med tidligere behandlet metastatisk kolorektal cancer (PROCEADE-CRC-03)

4. november 2026 opdateret af: EMD Serono Research & Development Institute, Inc.

Et randomiseret, åbent, 3-armet fase 3-studie af Precemtabart Tocentecan med eller uden Bevacizumab sammenlignet med Trifluridin/Tipiracil plus Bevacizumab hos deltagere med tidligere behandlet metastatisk kolorektal cancer (PROCEADE-CRC-03)

This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluridine/tipiracil (FTD-TPI) plus bevacizumab.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1020

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina, C1417DTB
        • Rekruttering
        • Investigaciones Clinicas Moleculares ICM
      • San Juan, Argentina, 5400
        • Rekruttering
        • Centro Oncologico de Excelencia
      • San Miguel de Tucumán, Argentina, T4000AXL
        • Rekruttering
        • Centro de Investigaciones Medicas Tucuman
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000KZE
        • Rekruttering
        • Instituto de Oncologia de Rosario
  • Australien
    • New South Wales
      • St Leonards, New South Wales, Australien, 2065
        • Rekruttering
        • GenesisCare North Shore (Oncology)
    • Queensland
      • Chermside, Queensland, Australien, 4032
        • Rekruttering
        • Icon Cancer Centre Chermside
      • South Brisbane, Queensland, Australien, 4101
        • Rekruttering
        • Mater Misericordiae Ltd - PARENT
    • South Australia
      • Bedford Park, South Australia, Australien, 5042
        • Rekruttering
        • Flinders Medical Centre
  • Belgien
      • Brussels, Belgien, 1200
        • Rekruttering
        • Cliniques Universitaires Saint-Luc - STL
      • Charleroi, Belgien, 6000
        • Rekruttering
        • Grand Hospital de Charleroi - PARENT
      • Edegem, Belgien, 2650
        • Rekruttering
        • UZA - Account 3
      • Leuven, Belgien, 03000
        • Rekruttering
        • UZ Leuven
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Rekruttering
        • BC Cancer - Vancouver - BC Cancer Agency
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Rekruttering
        • The Ottawa Hospital Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Rekruttering
        • University Health Network - Princess Margaret Cancer Centre
  • Danmark
      • Herning, Danmark, 7400
        • Rekruttering
        • Ålborg Universitets Hospital - PARENT
  • Det Forenede Kongerige
    • Grampian Region
      • Aberdeen, Grampian Region, Det Forenede Kongerige, AB25 2ZN
        • Rekruttering
        • Aberdeen Royal Infirmary - Dept of Oncology
    • Great Manchester
      • Manchester, Great Manchester, Det Forenede Kongerige, M20 4BX
        • Rekruttering
        • The Christie Hospital - Dept of Oncology
    • Greater London
      • London, Greater London, Det Forenede Kongerige, W1G 6AD
        • Rekruttering
        • Sarah Cannon Research Institute UK
  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94158
        • Rekruttering
        • UCSF Mount Zion Medical Ctr
    • Colorado
      • Lone Tree, Colorado, Forenede Stater, 80124
        • Rekruttering
        • Rocky Mountain Cancer Centers, LLP- Aurora
    • Florida
      • Fort Myers, Florida, Forenede Stater, 33901
        • Rekruttering
        • Florida Cancer Specialists-Broadway
      • St. Petersburg, Florida, Forenede Stater, 33701-4553
        • Rekruttering
        • Florida Cancer Specialists - St. Petersburg Bayfront
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Rekruttering
        • Florida Cancer Specialists East - FCS EAST - West Palm Beach
    • Illinois
      • Arlington Heights, Illinois, Forenede Stater, 60005
        • Rekruttering
        • Illinois Cancer Specialists
      • Peoria, Illinois, Forenede Stater, 61615-7822
        • Rekruttering
        • Illinois CancerCare PC
      • Springfield, Illinois, Forenede Stater, 62702
        • Rekruttering
        • Springfield Clinic
    • Michigan
      • Sterling Heights, Michigan, Forenede Stater, 48098
        • Rekruttering
        • Profound Research LLC at Cancer and Leukemia Center
    • Minnesota
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Rekruttering
        • Minnesota Oncology Hematology, P.A.
    • Missouri
      • Columbia, Missouri, Forenede Stater, 65201
        • Rekruttering
        • Missouri Cancer Associates - 150518964
    • New York
      • White Plains, New York, Forenede Stater, 10601
        • Rekruttering
        • White Plains Hospital Medical and Wellness PRIME
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29605
        • Rekruttering
        • Prisma Health Cancer Institute, ITOR, CRU
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57105
        • Rekruttering
        • Avera Cancer Institute - 300127370
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Rekruttering
        • SCRI Oncology Partners
    • Texas
      • Abilene, Texas, Forenede Stater, 79606
        • Rekruttering
        • Texas Oncology, P.A. - Abilene - 300210366
      • Austin, Texas, Forenede Stater, 78745
        • Rekruttering
        • Texas Oncology-South Austin
      • Bedford, Texas, Forenede Stater, 75246
        • Rekruttering
        • Texas Oncology DFW
      • San Antonio, Texas, Forenede Stater, 78240
        • Rekruttering
        • Texas Oncology- San Antonio
      • Tyler, Texas, Forenede Stater, 75702
        • Rekruttering
        • Texas Oncology, P.A. - Tyler
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23606
        • Rekruttering
        • Virginia Oncology Associates
      • Roanoke, Virginia, Forenede Stater, 24014-2419
        • Rekruttering
        • Blue Ridge Cancer Care - 300202915
  • Frankrig
      • Paris, Frankrig, 75013
        • Rekruttering
        • Groupe Hospitalier Pitie-Salpetriere - Service Hépato-Gastro-Entérologie
      • Paris, Frankrig, 75015
        • Rekruttering
        • Hôpital Européen Georges Pompidou - Hématologie Oncologie
    • Bouches-du-Rhône
      • Marseille, Bouches-du-Rhône, Frankrig, 13009
        • Rekruttering
        • Institut Paoli Calmettes - service d'oncologie medicale
    • Calvados
      • Caen, Calvados, Frankrig, 14033
        • Rekruttering
        • Centre Francois Baclesse - Service d'Oncologie Medicale
    • Gironde
      • Bordeaux, Gironde, Frankrig, 33076
        • Rekruttering
        • Institut Bergonié - Service d'Oncologie Médicale
    • Nord
      • Lille, Nord, Frankrig, 59037
        • Rekruttering
        • Hopital Claude Huriez - CHU Lille - service d'oncologie medicale
    • Pays de la Loire Region
      • Saint Priest En Jarez, Pays de la Loire Region, Frankrig, 42270
        • Rekruttering
        • CHU Saint Etienne - Hôpital Nord - Service de Gastro-Entérologie et Hépatologie
    • Rhone
      • Lyon, Rhone, Frankrig, 69008
        • Rekruttering
        • Centre Leon Berard - Service d'Oncologie Medicale
    • Val De Marne
      • Villejuif, Val De Marne, Frankrig, 94805
        • Rekruttering
        • Institut Gustave Roussy - Pathologies Digestives
  • Holland
      • Groningen, Holland, 9713GZ
        • Rekruttering
        • Universitair Medisch Centrum Groningen - Cancer Center
      • Utrecht, Holland, 3584 CX
        • Rekruttering
        • Amphia Ziekenhuis, Molengracht - Parent
  • Hong Kong
      • Hong Kong, Hong Kong, 00000
        • Rekruttering
        • The Chinese University of Hong Kong (CUHK) - Prince of Wales Hospital (PWH)
  • Italien
      • Milan, Italien, 20162
        • Rekruttering
        • Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda) - Struttura Complessa di Oncologia Falck
      • Naples, Italien, 80131
        • Rekruttering
        • Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Oncologia
      • Naples, Italien, 80131
        • Rekruttering
        • Istituto Nazionale Tumori Fondazione G. Pascale - Dipartimento Oncoematologia
      • Padova, Italien, 35128
        • Rekruttering
        • IOV - Istituto Oncologico Veneto IRCCS - S.Semplice Dip.Oncologia dei Melanomi
      • Pisa, Italien, 56126
        • Rekruttering
        • Azienda Ospedaliero Universitaria Pisana - U.O. Oncologia II
      • Rome, Italien, 00168
        • Rekruttering
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
    • Bari
      • Castellana Grotte, Bari, Italien, 70013
        • Rekruttering
        • Azienda Ospedaliera Saverio De Bellis - 300205674
    • Foggia
      • San Giovanni Rotondo, Foggia, Italien, 71013
        • Rekruttering
        • IEO Istituto Europeo di Oncologia - Divisione Oncologia Medica
  • Japan
      • Osaka, Japan, 541-8567
        • Rekruttering
        • Osaka International Cancer Institute
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 464-8681
        • Rekruttering
        • Aichi Cancer Center Hospital
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 811-1395
        • Rekruttering
        • NHO Kyushu Cancer Center - 300175822
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Rekruttering
        • Kanagawa Cancer Center - Dept of Gastroenterology
    • Osaka
      • Sakai-shi, Osaka, Japan, 590-0197
        • Rekruttering
        • Kindai University Hospital
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Rekruttering
        • Saitama Cancer Center - 300175812
    • Shizuoka
      • Sunto, Shizuoka, Japan, 411-8777
        • Rekruttering
        • Shizuoka Cancer Center
    • Tokyo-To
      • Chūōku, Tokyo-To, Japan, 104-0045
        • Rekruttering
        • National Cancer Center Hospital
      • Kōtoku, Tokyo-To, Japan, 135-8550
        • Rekruttering
        • Cancer Institute Hospital of JFCR
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Rekruttering
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, Kina, 100142
        • Rekruttering
        • Peking Union Medical College Hospital
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510060
        • Rekruttering
        • Sun Yat-sen University Cancer Center
      • Guangzhou, Guangdong, Kina, 510655
        • Rekruttering
        • The Sixth Affiliated Hospital of Sun Yat-sen University
      • Meizhou, Guangdong, Kina, 514031
        • Rekruttering
        • Meizhou Peoples Hospital - 300164707
    • Guangxi Zhuang
      • Nanning, Guangxi Zhuang, Kina, 530021
        • Rekruttering
        • Guangxi Medical University Cancer Hospital
    • Hong Kong
      • Hong Kong, Hong Kong, Kina, 00000
        • Rekruttering
        • The University of Hong Kong - 1
    • Hubei
      • Wuhan, Hubei, Kina, 430060
        • Rekruttering
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210029
        • Rekruttering
        • Jiangsu Province Hospital
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • Rekruttering
        • The First Affiliated Hospital of Nanchang University - Endocrine Secretion Department
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 201321
        • Rekruttering
        • Fudan University Shanghai Cancer Center
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Rekruttering
        • West China Hospital, Sichuan University
      • Chengdu, Sichuan, Kina, 610041
        • Rekruttering
        • Sichuan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • Rekruttering
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, Kina, 310000
        • Rekruttering
        • The Second Affiliated Hospital of Zhejiang University School of Medicine - 300173725
  • Polen
      • Gdansk, Polen, 80-219
        • Rekruttering
        • Wojewodzkie Centrum Onkologii
      • Krakow, Polen, 31-501
        • Rekruttering
        • SP ZOZ Szpital Uniwersytecki w Krakowie - Dept of Clinical Oncology and Oncology Clinic
  • Spanien
      • Barcelona, Spanien, 08036
        • Rekruttering
        • Hospital Clinic de Barcelona - Servicio de Oncologia
      • Barcelona, Spanien, 08035
        • Rekruttering
        • Hospital Universitari Vall d'Hebron - Oncology Dept.
      • Madrid, Spanien, 28034
        • Rekruttering
        • Hospital Universitario Ramon y Cajal - Servicio de Oncologia
      • Madrid, Spanien, 28041
        • Rekruttering
        • Hospital Universitario 12 de Octubre - Servicio de Oncologia
      • Seville, Spanien, 41014
        • Rekruttering
        • Hospital Universitario Nuestra Señora de Valme
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spanien, 08906
        • Rekruttering
        • ICO l'Hospitalet - Hospital Duran i Reynals - Servicio de Oncologia
    • Córdoba
      • Córdoba, Córdoba, Spanien, 14004
        • Rekruttering
        • Hospital Universitario Reina Sofia - Dept of Oncology
  • Sydkorea
      • Seoul, Sydkorea, 03080
        • Rekruttering
        • Seoul National University Hospital
      • Seoul, Sydkorea, 06351
        • Rekruttering
        • Samsung Medical Center
      • Seoul, Sydkorea, 08308
        • Rekruttering
        • Korea University Guro Hospital
      • Seoul, Sydkorea, 138-736
        • Rekruttering
        • Asan Medical Center
      • Seoul, Sydkorea, 03722
        • Rekruttering
        • Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
      • Seoul, Sydkorea, 06591
        • Rekruttering
        • The Catholic University of Korea, Seoul St. Maryâ
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Sydkorea, 10408
        • Rekruttering
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Sydkorea, 13620
        • Rekruttering
        • Seoul National University Bundang Hospital
    • Gyeongsangnam-do
      • Daegu, Gyeongsangnam-do, Sydkorea, 700-721
        • Rekruttering
        • Kyungpook National University Chilgok Hospital
  • Taiwan
      • Kaohsiung City, Taiwan, 807
        • Rekruttering
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung City, Taiwan, 833
        • Rekruttering
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 40447
        • Rekruttering
        • China Medical University Hospital
      • Tainan, Taiwan, 70403
        • Rekruttering
        • National Cheng Kung University Hospital - Internal Medicine
      • Tainan, Taiwan, 736
        • Rekruttering
        • Chi Mei Hospital, Liouying
      • Taipei, Taiwan, 11217
        • Rekruttering
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 100225
        • Rekruttering
        • National Taiwan University Hospital
  • Tyskland
      • Berlin, Tyskland, 13353
        • Rekruttering
        • Charité - Campus Charité Mitte - Medizinische Klinik II (Onkologie u. Haematologie)
      • Hamburg, Tyskland, 20249
        • Rekruttering
        • Haematologisch-Onkologische Praxis Eppendorf (HOPE)
    • Hesse
      • Frankfurt am Main, Hesse, Tyskland, 60488
        • Rekruttering
        • Krankenhaus Nordwest GmbH - Neurologische Klinik
    • Saxony
      • Leipzig, Saxony, Tyskland, 04103
        • Rekruttering
        • Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL)
  • Østrig
      • Salzburg, Østrig, 5020
        • Rekruttering
        • LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
      • Vienna, Østrig, 1090
        • Rekruttering
        • AKH - Medizinische Universität Wien - Klinik für Innere Medizin 1

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setting.
  • Participants must have received and progressed on no more than 2 previous systemic treatment regimens in the metastatic setting
  • Eastern Cooperative Oncology Group (ECOG) performance status less than equal to 1
  • Participants must be able to swallow oral tablets, and to comply with the study requirements for all scheduled evaluations
  • Other protocol defined inclusion criteria may apply

Exclusion Criteria:

  • If Adverse Events related to previous therapies have not recovered to less than Grade 1 by National Cancer Institute - Common Terminology Criteria for Adverse Events version 6.0
  • Participant has a history of additional malignancy within 3 years before randomization
  • Participants with known brain metastases
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months prior to randomization
  • Participants with ileus of more than Grade 1, or chronic inflammatory bowel disease (example ulcerative colitis, Crohn's disease) and/or bowel obstruction, or participants with chronic gastrointestinal disorders that, in the Investigator's opinion, might significantly interfere with proper absorption of the study treatments
  • Other protocol defined exclusion criteria may apply

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm 1: Precemtabart tocentecan (Precem-TcT) monoterapi
Medicin: Precemtabart tocentecan

Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.

Andre navne:
  • Precem-TcT
Eksperimentel: Arm 2: Precem-TcT plus Bevacizumab
Medicin: Precemtabart tocentecan

Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.

Andre navne:
  • Precem-TcT
Medicin: Bevacizumab

Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.
Aktiv komparator: Arm 3: Trifluridin/Tipiracil (FTD-TPI) plus Bevacizumab
Medicin: Bevacizumab

Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.

Medicin: Trifluridine/Tipiracil (FTD-TPI)

FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Arm 1, 2 og 3: Samlet overlevelse
Tidsramme: Tid fra randomiseringsdato til død, vurderet indtil ca. gennemsnitligt 19 måneder
Tid fra randomiseringsdato til død, vurderet indtil ca. gennemsnitligt 19 måneder

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Arm 1 og Arm 2: Samlet overlevelse
Tidsramme: Tid fra datoen for randomisering til død, vurderet cirka op til gennemsnit på 19 måneder
Tid fra datoen for randomisering til død, vurderet cirka op til gennemsnit på 19 måneder
Progressionsfri overlevelse (PFS)
Tidsramme: Tid fra randomisering til første forekomst af sygdomsprogression eller død, alt efter hvad der indtræffer først (vurderet op til gennemsnitligt 19 måneder)
Tid fra randomisering til første forekomst af sygdomsprogression eller død, alt efter hvad der indtræffer først (vurderet op til gennemsnitligt 19 måneder)
Objektiv respons (OR) i henhold til Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) vurderet af investigator
Tidsramme: Op til gennemsnitligt 19 måneder
Op til gennemsnitligt 19 måneder
Responsvarighed vurderet af investigator
Tidsramme: Tid fra første dokumentation af objektiv respons til PD eller død (vurderet op til gennemsnitligt 19 måneder)
Tid fra første dokumentation af objektiv respons til PD eller død (vurderet op til gennemsnitligt 19 måneder)
Antal deltagere med uønskede hændelser (AE'er) og behandlingsrelaterede uønskede hændelser
Tidsramme: Op til gennemsnitligt 19 måneder
Op til gennemsnitligt 19 måneder
Observed Concentration at End of Infusion (CEOI) Period
Tidsramme: At end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (Arm 1 and Arm 2 only; each cycle is for 21 days)
At end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (Arm 1 and Arm 2 only; each cycle is for 21 days)
Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough)
Tidsramme: At end of dosing interval on Cycle1Day1,Cycle2Day1,Cycle3Day1,Cycle4Day1, Cycle5Day1,Cycle6Day1,Cycle7Day1 until treatment discontinuation(assessed up to average of 19months (Arm 1 and Arm 2 only; each cycle is for 21 days)
At end of dosing interval on Cycle1Day1,Cycle2Day1,Cycle3Day1,Cycle4Day1, Cycle5Day1,Cycle6Day1,Cycle7Day1 until treatment discontinuation(assessed up to average of 19months (Arm 1 and Arm 2 only; each cycle is for 21 days)
Number of Participants with Anti-Drug Antibody as measured by ADA assay
Tidsramme: Predose(-4to0 hours)on Cycle1Day1,Cycle2 Day1,Cycle 3Day1,Cycle4Day1, Cycle8Day1;thereafter every 4cycles until treatment discontinuation(assessed up to average of 19 months) (Arm 1 and Arm 2 only; each cycle is for 21 days)
Predose(-4to0 hours)on Cycle1Day1,Cycle2 Day1,Cycle 3Day1,Cycle4Day1, Cycle8Day1;thereafter every 4cycles until treatment discontinuation(assessed up to average of 19 months) (Arm 1 and Arm 2 only; each cycle is for 21 days)
Change from Baseline in Global Health Status, Physical, and Role Functioning Subscale Scores of European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
Tidsramme: Baseline, Cycle 1 Day 1 and Day 1 of every new cycle until treatment discontinuation (assessed up to average of 19 months).

EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Baseline, Cycle 1 Day 1 and Day 1 of every new cycle until treatment discontinuation (assessed up to average of 19 months).

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

EMD Serono Research & Development Institute, Inc.

Samarbejdspartnere

Merck KGaA, Darmstadt, Germany

Efterforskere

  • Studieleder: Medical Responsible, EMD Serono Research & Development Institute, Inc.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. maj 2026

Primær færdiggørelse (Anslået)

16. oktober 2029

Studieafslutning (Anslået)

16. oktober 2029

Datoer for studieregistrering

Først indsendt

16. april 2026

Først indsendt, der opfyldte QC-kriterier

16. april 2026

Først opslået (Faktiske)

24. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MS914001_0002
  • 2025-524648-37-00 (Ctis)
  • CTR20262356 (Anden identifikator: ChinaDrugTrials.org.cn)
  • jRCT2031260267 (Anden identifikator: JRCT (Japan))
  • 2025 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

IPD supporting publicly available results will be evaluated for sharing.

IPD-delingstidsramme

IPD from completed trials will be publicly available within 6 months after all of the following events:

  • Approval of a product/new indication by major authorities (FDA, EMA, PMDA if requested) with no pending submissions
  • Public results via primary manuscript or trial registry disclosure
  • Legal authority to share data
  • Privacy protections are in place If approval is not sought or development is globally discontinued, data will be publicly available within 18 months after global trial completion. Further information on how to request data can be found on our website bit.ly/IPD21

IPD-delingsadgangskriterier

Qualified researchers may propose access to IPD from sponsored trials via https://vivli.org/members/ourmembers/.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner