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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 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

812

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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 føderasjonen
    • Leningradskaya Oblast
      • Saint Petersburg, Leningradskaya Oblast, Den russiske føderasjonen, 197758
        • Local Institution - 0100
    • Moskva
      • Moscow, Moskva, Den russiske føderasjonen, 115478
        • Local Institution - 0160
    • Sankt-Peterburg
      • St. Petersburg, Sankt-Peterburg, Den russiske føderasjonen, 198255
        • Local Institution - 0099
  • Finland
      • Pori, Finland, FI-28500
        • Local Institution - 0023
    • Pohjois-Pohjanmaa
      • Oulu, Pohjois-Pohjanmaa, Finland, 90230
        • Local Institution - 0022
  • Hellas
      • Athens, Hellas, 11527
        • Local Institution - 0051
      • Heraklion, Hellas, 71110
        • Local Institution - 0052
      • Nea Kifisia Athens, Hellas, 14564
        • Local Institution - 0177
      • Patras, Hellas, 26504
        • Local Institution - 0148
      • Thessaloniki, Hellas, 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
  • Romania
      • Bucharest, Romania, 022328
        • Local Institution - 0095
      • Bucharest, Romania, 030171
        • Local Institution - 0096
      • Cluj Napoca, Romania, 400015
        • Local Institution - 0097
    • Bihor
      • Oradea, Bihor, Romania, 410469
        • Local Institution - 0192
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400058
        • Local Institution - 0098
    • Timis
      • Timisoara, Timis, Romania, 300167
        • Local Institution - 0187
  • Spania
      • A Coruna, Spania, 15006
        • Local Institution - 0104
      • Alicante, Spania, 03010
        • Local Institution - 0119
      • Barcelona, Spania, 08036
        • Local Institution - 0162
      • Barcelona, Spania, 08916
        • Local Institution - 0112
      • Barcelona, Spania, 8028
        • Local Institution - 0111
      • Barcelona, Spania, 8035
        • Local Institution - 0110
      • Burgos, Spania, 09006
        • Local Institution - 0108
      • Granada, Spania, 18014
        • Local Institution - 0103
      • Madrid, Spania, 28034
        • Local Institution - 0114
      • Madrid, Spania, 28040
        • Local Institution - 0117
      • Madrid, Spania, 28041
        • Local Institution - 0116
      • Madrid, Spania, 28046
        • Local Institution - 0105
      • Malaga, Spania, 29010
        • Local Institution - 0106
      • Palma de Mallorca, Spania, 07198
        • Local Institution - 0113
      • Seville, Spania, 41013
        • Local Institution - 0118
      • Valencia, Spania, 46010
        • Local Institution - 0161
      • Valencia, Spania, 46026
        • Local Institution - 0102
      • Zaragoza, Spania, 50009
        • Local Institution - 0163
    • Asturias
      • Oviedo, Asturias, Spania, 33006
        • Local Institution - 0337
    • Cantabria
      • Santander, Cantabria, Spania, 39008
        • Local Institution - 0109
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spania, 38320
        • Local Institution - 0107
  • Storbritannia
      • Bebington, Storbritannia, CH63 4JY
        • Local Institution - 0171
      • Bodelwyddan, Rhyl, Storbritannia, LL18 5UJ
        • Local Institution - 0340
      • Bradford, Storbritannia, BD9 6RJ
        • Local Institution - 0344
      • Bristol, Storbritannia, BS2 8ED
        • Local Institution - 0190
      • Cardiff, Storbritannia, CF14 2TL
        • Local Institution - 0133
      • Cottingham, Storbritannia, HU16 5JQ
        • Local Institution - 0126
      • London, Storbritannia, W1T 7HA
        • Local Institution - 0165
      • London, Storbritannia, W6 8RF
        • Local Institution - 0169
      • Northwood, Storbritannia, HA6 2RN
        • Local Institution - 0194
      • Plymouth, Storbritannia, PL6 8DH
        • Local Institution - 0166
      • Sheffield, Storbritannia, S10 5SJ
        • Local Institution - 0124
      • Sutton, Storbritannia, SM2 5PT
        • Local Institution - 0189
      • West Midlands, Storbritannia, CV2 2DX
        • Local Institution - 0338
    • Aberdeen CITY
      • Aberdeen, Aberdeen CITY, Storbritannia, AB25 2ZN
        • Local Institution - 0345
    • Greater London
      • London, Greater London, Storbritannia, N18 1QX
        • Local Institution - 0127
    • Greater Manchester
      • Manchester, Greater Manchester, Storbritannia, M20 4BX
        • Local Institution - 0191
    • Hampshire
      • Southampton, Hampshire, Storbritannia, SO16 6YD
        • Local Institution - 0131
    • Kent
      • Maidstone, Kent, Storbritannia, ME16 9QQ
        • Local Institution - 0128
    • Lanarkshire
      • Glasgow, Lanarkshire, Storbritannia, G12 0YN
        • Local Institution - 0195
    • Lancashire
      • Preston, Lancashire, Storbritannia, PR2 9HT
        • Local Institution - 0132
    • Leicestershire
      • Leicester, Leicestershire, Storbritannia, LE1 5WW
        • Local Institution - 0167
    • Surrey
      • Sutton, Surrey, Storbritannia, SM2 5PT
        • Local Institution - 0196
  • 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
  • Østerrike
      • Salzburg, Østerrike, 5020
        • Local Institution - 0003
      • Wien, Østerrike, 1140
        • Local Institution - 0005
    • Oberösterreich
      • Wels, Oberösterreich, Østerrike, 4600
        • Local Institution - 0002

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Annen
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
Legemiddel: Nivolumab

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Bristol-Myers Squibb

Samarbeidspartnere

PPD

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

29. april 2015

Primær fullføring (Faktiske)

7. mars 2018

Studiet fullført (Faktiske)

27. august 2021

Datoer for studieregistrering

Først innsendt

1. april 2015

Først innsendt som oppfylte QC-kriteriene

3. april 2015

Først lagt ut (Anslag)

6. april 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. november 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. oktober 2022

Sist bekreftet

1. oktober 2022

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Ikke-småcellet lungekreft

Kliniske studier på Nivolumab

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Burkina Faso

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere