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Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

6. september 2022 opdateret af: Bristol-Myers Squibb

An Open Label, Randomized Phase 3 Clinical Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (SCCHN)

The purpose of this study is to find out whether Nivolumab will significantly improve overall survival as compared to therapy of investigator's choice in patients with recurrent or metastatic head and neck carcinoma.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

361

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Argentina
      • Cordoba, Argentina, 5000
        • Local Institution - 0014
    • Buenos Aires
      • Berazategui, Buenos Aires, Argentina, 1880
        • Local Institution - 0015
    • Tucuman
      • San Miguel De Tucuman, Tucuman, Argentina, 4000
        • Local Institution - 0013
  • Brasilien
      • Sao Paulo, Brasilien, 01321-001
        • Local Institution - 0055
    • RIO Grande DO SUL
      • Ijui, RIO Grande DO SUL, Brasilien, 98700-000
        • Local Institution - 0054
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasilien, 90610-000
        • Local Institution
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Local Institution - 0038
    • Ontario
      • London, Ontario, Canada, N6A 4L6
        • Local Institution - 0045
  • Det Forenede Kongerige
      • Surrey, Det Forenede Kongerige, SM2 5PT
        • Local Institution
    • Greater London
      • London, Greater London, Det Forenede Kongerige, SW3 6JJ
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, Det Forenede Kongerige, M20 4BX
        • Local Institution
    • Hampshire
      • Southampton, Hampshire, Det Forenede Kongerige, SO16 6YD
        • Local Institution
    • Merseyside
      • Wirral, Merseyside, Det Forenede Kongerige, CH63 4JY
        • Local Institution
  • Forenede Stater
    • California
      • Stanford, California, Forenede Stater, 94305
        • Stanford University Medical Center
    • Florida
      • Tampa, Florida, Forenede Stater, 33612
        • H. Lee Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Local Institution - 0001
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • Local Institution - 0002
    • Louisiana
      • Metairie, Louisiana, Forenede Stater, 70006
        • Local Institution - 0004
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater, 02215
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • DUMC
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • Local Institution - 0012
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Local Institution - 0007
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt Cancer Clinic
    • Texas
      • Hoston, Texas, Forenede Stater, 77030
        • Univ Of Tx. Md Anderson
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84112
        • Huntsman Cancer Institute
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Local Institution - 0031
  • Frankrig
      • Lyon Cedex 08, Frankrig, 69373
        • Local Institution
      • Nice Cedex 2, Frankrig, 06189
        • Local Institution
      • Villejuif Cedex, Frankrig, 94805
        • Local Institution
  • Holland
      • Amsterdam, Holland, 1081 HV
        • Local Institution
      • Groningen, Holland, 9713 AP
        • Local Institution
      • Leiden, Holland, 2333 ZA
        • Local Institution
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution
  • Italien
      • Milano, Italien, 20142
        • Local Institution
      • Napoli, Italien, 80131
        • Local Institution
      • Padova, Italien, 35128
        • Local Institution
    • FC
      • Meldola, FC, Italien, 47014
        • Ist.Scient. Romagnolo Per Lo Studio E Cura Tumori
    • MI
      • Milano, MI, Italien, 20133
        • Local Institution
    • TO
      • Torino, TO, Italien, 10126
        • Local Institution
  • Japan
      • Akashi, Hyogo, Japan, 673-8558
        • Local Institution - 0057
      • Tokyo, Japan, 135-8550
        • Local Institution - 0061
    • Aichi
      • Nagoya, Aichi, Japan, 4648681
        • Local Institution - 0056
    • Chiba
      • Kashiwa, Chiba, Japan, 2778577
        • Local Institution - 0060
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 0608648
        • Local Institution - 0062
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Local Institution - 0058
    • Osaka
      • Takatsuki, Osaka, Japan, 5698686
        • Local Institution - 0063
    • Shizuoka
      • Sunto-gun, Shizuoka, Japan, 4118777
        • Local Institution - 0059
  • Korea, Republikken
      • Seoul, Korea, Republikken, 135-710
        • Local Institution - 0067
      • Seoul, Korea, Republikken, 137-701
        • Local Institution - 0066
  • Schweiz
      • Zuerich, Schweiz, 8091
        • Local Institution - 0051
  • Spanien
      • Barcelona, Spanien, 08035
        • Local Institution - 0032
      • Barcelona, Spanien, 08036
        • Local Institution - 0035
      • Madrid, Spanien, 28041
        • Local Institution - 0034
      • Valencia, Spanien, 46010
        • Local Institution - 0033
  • Taiwan
      • Tainan, Taiwan, 704
        • Local Institution - 0065
      • Taipei, Taiwan, 100
        • Local Institution - 0064
  • Tyskland
      • Berlin, Tyskland, 12200
        • Local Institution - 0047
      • Bonn, Tyskland, 53127
        • Local Institution - 0049
      • Essen, Tyskland, 45122
        • Local Institution - 0048
      • Hamburg, Tyskland, 20246
        • Local Institution - 0052
      • Hannover, Tyskland, 30625
        • Local Institution - 0046
      • Wuerzburg, Tyskland, 97070
        • Local Institution - 0050

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

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • Men and women ≥ 18 years of age with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Histologically confirmed recurrent or metastatic SCCHN (oral cavity, pharynx, larynx), stage III/IV and not amenable to local therapy with curative intent (surgery or radiation therapy with or without chemotherapy)
  • Tumor progression or recurrence within 6 months of last dose of platinum therapy in the adjuvant (ie with radiation after surgery), primary (ie, with radiation), recurrent, or metastatic setting
  • Measurable disease by Computed tomography (CT) or Magnetic resonance imaging (MRI) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria

Exclusion Criteria:

  • Active brain metastases or leptomeningeal metastases are not allowed
  • Histologically confirmed recurrent or metastatic carcinoma of the nasopharynx, squamous cell carcinoma of unknown primary, and salivary gland or non-squamous histologies (eg: mucosal melanoma) are not allowed
  • Subjects with active, known or suspected autoimmune disease

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 A: Nivolumab
Nivolumab 3mg/kg intravenous (IV) Solution for Injection every 2 weeks until disease progression
Medicin: Nivolumab
Andre navne:
  • BMS-936558
Aktiv komparator: Arm B: Cetuximab/Methotrexate/Docetaxel

Cetuximab intravenous (IV) Solution for Injection 400 mg/m2 (first dose) then 250 mg/m2 weekly until disease progression

OR

Methotrexate intravenous (IV) Solution for Injection 40 or 60 mg/m2 weekly until disease progression

OR

Docetaxel intravenous (IV) Solution for Injection 30 or 40 mg/m2 weekly until disease progression
Medicin: Docetaxel
Medicin: Methotrexat
Medicin: Cetuximab

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: From date of randomization to date of death (Up to approximately 18 months)
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
From date of randomization to date of death (Up to approximately 18 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Investigator-Assessed Progression-Free Survival (PFS)
Tidsramme: From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)

PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST1.1)), or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5mm. Participants who:

  • Die without a reported progression were considered to have progressed on the date of their death.
  • Did not progress or die were censored on the date of their last evaluable tumor assessment.
  • Without any on study tumor assessments and did not die were censored on their date of randomization.
  • Received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.
From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)
Investigator-Assessed Objective Response Rate (ORR)
Tidsramme: From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)
ORR was defined as the percentage of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

Samarbejdspartnere

Ono Pharmaceutical Co. Ltd

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.

Generelle publikationer

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)

29. maj 2014

Primær færdiggørelse (Faktiske)

6. november 2015

Studieafslutning (Faktiske)

10. september 2021

Datoer for studieregistrering

Først indsendt

3. april 2014

Først indsendt, der opfyldte QC-kriterier

4. april 2014

Først opslået (Skøn)

7. april 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. september 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA209-141
  • 2013-003622-86 (EudraCT nummer)

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 .

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner