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An Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) Monotherapy in Subjects With Advanced or Metastatic Squamous Cell (Sq) Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Prior Systemic Regimen for the Treatment of Stage IIIb/IV SqNSCLC (Checkmate 171)

17. oktober 2022 opdateret af: Bristol-Myers Squibb
The purpose of the study is to determine the occurrence of high-grade (CTCAE v4.0 Grades 3-4), treatment-related, select adverse events in patients with advanced or metastatic Squamous Cell Non-Small Cell Lung Cancer (SqNSCLC) with progression of disease during or after at least 1 systemic therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

812

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Danmark
      • Aalborg, Danmark, 9000
        • Local Institution - 0021
      • Herlev, Danmark, 2730
        • Local Institution - 0020
    • South Denmark
      • Odense, South Denmark, Danmark, 5000
        • Local Institution - 0173
  • Den Russiske Føderation
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Den Russiske Føderation, 197758
        • Local Institution - 0100
    • Moskva
      • Moscow, Moskva, Den Russiske Føderation, 115478
        • Local Institution - 0160
    • Sankt-Peterburg
      • St. Petersburg, Sankt-Peterburg, Den Russiske Føderation, 198255
        • Local Institution - 0099
  • Det Forenede Kongerige
      • Bebington, Det Forenede Kongerige, CH63 4JY
        • Local Institution - 0171
      • Bodelwyddan, Rhyl, Det Forenede Kongerige, LL18 5UJ
        • Local Institution - 0340
      • Bradford, Det Forenede Kongerige, BD9 6RJ
        • Local Institution - 0344
      • Bristol, Det Forenede Kongerige, BS2 8ED
        • Local Institution - 0190
      • Cardiff, Det Forenede Kongerige, CF14 2TL
        • Local Institution - 0133
      • Cottingham, Det Forenede Kongerige, HU16 5JQ
        • Local Institution - 0126
      • London, Det Forenede Kongerige, W1T 7HA
        • Local Institution - 0165
      • London, Det Forenede Kongerige, W6 8RF
        • Local Institution - 0169
      • Northwood, Det Forenede Kongerige, HA6 2RN
        • Local Institution - 0194
      • Plymouth, Det Forenede Kongerige, PL6 8DH
        • Local Institution - 0166
      • Sheffield, Det Forenede Kongerige, S10 5SJ
        • Local Institution - 0124
      • Sutton, Det Forenede Kongerige, SM2 5PT
        • Local Institution - 0189
      • West Midlands, Det Forenede Kongerige, CV2 2DX
        • Local Institution - 0338
    • Aberdeen CITY
      • Aberdeen, Aberdeen CITY, Det Forenede Kongerige, AB25 2ZN
        • Local Institution - 0345
    • Greater London
      • London, Greater London, Det Forenede Kongerige, N18 1QX
        • Local Institution - 0127
    • Greater Manchester
      • Manchester, Greater Manchester, Det Forenede Kongerige, M20 4BX
        • Local Institution - 0191
    • Hampshire
      • Southampton, Hampshire, Det Forenede Kongerige, SO16 6YD
        • Local Institution - 0131
    • Kent
      • Maidstone, Kent, Det Forenede Kongerige, ME16 9QQ
        • Local Institution - 0128
    • Lanarkshire
      • Glasgow, Lanarkshire, Det Forenede Kongerige, G12 0YN
        • Local Institution - 0195
    • Lancashire
      • Preston, Lancashire, Det Forenede Kongerige, PR2 9HT
        • Local Institution - 0132
    • Leicestershire
      • Leicester, Leicestershire, Det Forenede Kongerige, LE1 5WW
        • Local Institution - 0167
    • Surrey
      • Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
        • Local Institution - 0196
  • Finland
      • Pori, Finland, FI-28500
        • Local Institution - 0023
    • Pohjois-Pohjanmaa
      • Oulu, Pohjois-Pohjanmaa, Finland, 90230
        • Local Institution - 0022
  • Grækenland
      • Athens, Grækenland, 11527
        • Local Institution - 0051
      • Heraklion, Grækenland, 71110
        • Local Institution - 0052
      • Nea Kifisia Athens, Grækenland, 14564
        • Local Institution - 0177
      • Patras, Grækenland, 26504
        • Local Institution - 0148
      • Thessaloniki, Grækenland, 57010
        • Local Institution - 0147
  • Irland
      • Dublin 8, Irland
        • Local Institution - 0056
      • Galway, Irland, ST4 6QG
        • Local Institution - 0058
      • Tullamore, Offaly, Irland
        • Local Institution - 0349
  • Polen
      • Gdansk, Polen, 80-214
        • Local Institution - 0086
      • Lodz, Polen, 90-302
        • Local Institution - 0088
      • Warszawa, Polen, 04-141
        • Local Institution - 0089
    • Slaskie
      • Gliwice, Slaskie, Polen, 44-100
        • Local Institution - 0158
      • Zabrze, Slaskie, Polen, 41-803
        • Local Institution - 0184
    • Wielkopolskie
      • Poznan, Wielkopolskie, Polen, 60-693
        • Local Institution - 0087
  • Portugal
      • Coimbra, Portugal, 3000-602
        • Local Institution - 0094
      • Lisboa, Portugal, 1099-023
        • Local Institution - 0093
      • Lisboa, Portugal, 1769-001
        • Local Institution - 0090
      • Porto, Portugal, 4099-001
        • Local Institution - 0092
      • Porto, Portugal, 4200-072
        • Local Institution - 0091
      • Porto, Portugal, 4200-319
        • Local Institution - 0159
  • Rumænien
      • Bucharest, Rumænien, 022328
        • Local Institution - 0095
      • Bucharest, Rumænien, 030171
        • Local Institution - 0096
      • Cluj Napoca, Rumænien, 400015
        • Local Institution - 0097
    • Bihor
      • Oradea, Bihor, Rumænien, 410469
        • Local Institution - 0192
    • Cluj
      • Cluj-Napoca, Cluj, Rumænien, 400058
        • Local Institution - 0098
    • Timis
      • Timisoara, Timis, Rumænien, 300167
        • Local Institution - 0187
  • Spanien
      • A Coruna, Spanien, 15006
        • Local Institution - 0104
      • Alicante, Spanien, 03010
        • Local Institution - 0119
      • Barcelona, Spanien, 08036
        • Local Institution - 0162
      • Barcelona, Spanien, 08916
        • Local Institution - 0112
      • Barcelona, Spanien, 8028
        • Local Institution - 0111
      • Barcelona, Spanien, 8035
        • Local Institution - 0110
      • Burgos, Spanien, 09006
        • Local Institution - 0108
      • Granada, Spanien, 18014
        • Local Institution - 0103
      • Madrid, Spanien, 28034
        • Local Institution - 0114
      • Madrid, Spanien, 28040
        • Local Institution - 0117
      • Madrid, Spanien, 28041
        • Local Institution - 0116
      • Madrid, Spanien, 28046
        • Local Institution - 0105
      • Malaga, Spanien, 29010
        • Local Institution - 0106
      • Palma de Mallorca, Spanien, 07198
        • Local Institution - 0113
      • Seville, Spanien, 41013
        • Local Institution - 0118
      • Valencia, Spanien, 46010
        • Local Institution - 0161
      • Valencia, Spanien, 46026
        • Local Institution - 0102
      • Zaragoza, Spanien, 50009
        • Local Institution - 0163
    • Asturias
      • Oviedo, Asturias, Spanien, 33006
        • Local Institution - 0337
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Local Institution - 0109
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spanien, 38320
        • Local Institution - 0107
  • Sverige
      • Linköping, Sverige, 581 85
        • Local Institution - 0348
      • Lund, Sverige, 22185
        • Local Institution - 0342
      • Stockholm, Sverige, 171 76
        • Local Institution - 0120
    • Orebro Lan
      • Örebro, Orebro Lan, Sverige, SE-70185
        • Local Institution - 0339
    • Stockholms Lan
      • Stockholm, Stockholms Lan, Sverige, 17176
        • Local Institution - 0346
    • Vastra Gotalands Lan
      • Goteborg, Vastra Gotalands Lan, Sverige, 41345
        • Local Institution - 0193
  • Ungarn
      • Budapest, Ungarn, 1121
        • Local Institution - 0053
      • Budapest, Ungarn, 1125
        • Local Institution - 0347
      • Debrecen, Ungarn, 4032
        • Local Institution - 0178
    • Baranya
      • Pécs, Baranya, Ungarn, 7624
        • Local Institution - 0054
  • Østrig
      • Salzburg, Østrig, 5020
        • Local Institution - 0003
      • Wien, Østrig, 1140
        • Local Institution - 0005
    • Oberösterreich
      • Wels, Oberösterreich, Østrig, 4600
        • Local Institution - 0002

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:

  • ECOG Status: PS 0-1 & PS 2
  • Subjects with histologically or cytologically-documented SqNSCLC
  • Subjects must have experienced disease progression or recurrence during or after one prior platinum doublet-based chemotherapy regimen
  • Subjects must have evaluable disease by CT or MRI per RECIST 1.1 criteria
  • Subjects with treated or asymptomatic CNS metastases
  • Prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration
  • Prior lines of antineoplastic therapy, including hemotherapy, hormonal therapy, immunotherapy, surgical resection of lesions, non-palliative radiation therapy, or standard or investigational agents for treatment of NSCLC, must be completed 28 days prior to the first dose of nivolumab
  • Males and Females, ages 18 or older

Exclusion Criteria:

  • Subjects with untreated, symptomatic CNS metastases
  • Subjects with carcinomatous meningitis
  • Subjects with active, known or suspected autoimmune disease.
  • Subjects who received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways) or who have previously taken part in a randomized BMS clinical trial for nivolumab or ipilimumab.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
Medicin: Nivolumab

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With High Grade (Grade 3, 4 and 5) Treatment Related Select Adverse Events
Tidsramme: From first dose to time of analysis of primary endpoint (approximately up to 34 months)
The total number of participants with high grade treatment related select adverse events.
From first dose to time of analysis of primary endpoint (approximately up to 34 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants With High Grade Select Adverse Events
Tidsramme: From first dose up to 100 days post last dose (up to 76 months)
The total number of participants with high grade select adverse events. High grade is defined as Common Terminology Criteria for Adverse Events (CTCAE) v4.0 Grades 3-4. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
From first dose up to 100 days post last dose (up to 76 months)
Median Time to Onset of Any Grade Select Adverse Events
Tidsramme: From first dose up to 100 days post last dose (up to approximately 65 months)
Median Time to onset of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
From first dose up to 100 days post last dose (up to approximately 65 months)
Median Time to Resolution of Any Grade Select Adverse Events
Tidsramme: From first dose to up to 100 days post last dose (up to approximately 45 months)
Median time to resolution of any grade select adverse events reported up to 100 days after last dose. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. Select AEs include Pulmonary toxicity, Gastrointestinal toxicity (diarrhea or colitis, Endocrinopathies, Hepatotoxicity (including asymptomatic LFT elevations), Renal toxicity, Skin toxicity, and Neurological toxicity.
From first dose to up to 100 days post last dose (up to approximately 45 months)
Overall Survival
Tidsramme: From the first dosing up to the date of death (up to approximately 76 months)
Overall Survival (OS) is defined as the time from first dosing date to the date of death. A subject who has not died will be censored at last known date alive. OS will be followed continuously while subjects are on treatment and every 3 months via in-person or phone contact after subjects discontinue the study drug.
From the first dosing up to the date of death (up to approximately 76 months)
Objective Response Rate (ORR)
Tidsramme: From first dose up to last dose (up to approximately 76 months)
ORR is defined as the percentage of subjects with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR). CR is defined as the disappearance of all target lesions; PR is defined by at least a 30% decrease in the sum of the longest diameter of target lesions. ORR as assessed by the investigator will be reported.
From first dose up to last dose (up to approximately 76 months)

Samarbejdspartnere og efterforskere

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

Sponsor

Bristol-Myers Squibb

Samarbejdspartnere

PPD

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. april 2015

Primær færdiggørelse (Faktiske)

7. marts 2018

Studieafslutning (Faktiske)

27. august 2021

Datoer for studieregistrering

Først indsendt

1. april 2015

Først indsendt, der opfyldte QC-kriterier

3. april 2015

Først opslået (Skøn)

6. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. oktober 2022

Sidst verificeret

1. oktober 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CA209-171
  • 2014-001285-10 (EudraCT nummer)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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 .

Kliniske forsøg med Ikke-småcellet lungekræft

Kliniske forsøg med Nivolumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Myanmar

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner