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)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Aalborg, Danmark, 9000
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Herlev, Danmark, 2730
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South Denmark
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Odense, South Denmark, Danmark, 5000
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Leningradskaya Oblast
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Saint Petersburg, Leningradskaya Oblast, Den Russiske Føderation, 197758
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Moskva
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Moscow, Moskva, Den Russiske Føderation, 115478
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Sankt-Peterburg
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St. Petersburg, Sankt-Peterburg, Den Russiske Føderation, 198255
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Bebington, Det Forenede Kongerige, CH63 4JY
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Bodelwyddan, Rhyl, Det Forenede Kongerige, LL18 5UJ
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Sheffield, Det Forenede Kongerige, S10 5SJ
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West Midlands, Det Forenede Kongerige, CV2 2DX
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Aberdeen CITY
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Aberdeen, Aberdeen CITY, Det Forenede Kongerige, AB25 2ZN
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Greater London
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London, Greater London, Det Forenede Kongerige, N18 1QX
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Greater Manchester
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Manchester, Greater Manchester, Det Forenede Kongerige, M20 4BX
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Hampshire
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Southampton, Hampshire, Det Forenede Kongerige, SO16 6YD
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Maidstone, Kent, Det Forenede Kongerige, ME16 9QQ
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Glasgow, Lanarkshire, Det Forenede Kongerige, G12 0YN
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Preston, Lancashire, Det Forenede Kongerige, PR2 9HT
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Leicestershire
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Leicester, Leicestershire, Det Forenede Kongerige, LE1 5WW
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Surrey
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Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
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Pori, Finland, FI-28500
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Pohjois-Pohjanmaa
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Oulu, Pohjois-Pohjanmaa, Finland, 90230
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Athens, Grækenland, 11527
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Heraklion, Grækenland, 71110
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Nea Kifisia Athens, Grækenland, 14564
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Patras, Grækenland, 26504
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Thessaloniki, Grækenland, 57010
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Dublin 8, Irland
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Galway, Irland, ST4 6QG
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Tullamore, Offaly, Irland
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Gdansk, Polen, 80-214
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Lodz, Polen, 90-302
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Warszawa, Polen, 04-141
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Slaskie
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Gliwice, Slaskie, Polen, 44-100
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Zabrze, Slaskie, Polen, 41-803
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Wielkopolskie
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Poznan, Wielkopolskie, Polen, 60-693
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Coimbra, Portugal, 3000-602
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Lisboa, Portugal, 1099-023
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Lisboa, Portugal, 1769-001
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Porto, Portugal, 4099-001
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Porto, Portugal, 4200-072
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Porto, Portugal, 4200-319
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Bucharest, Rumænien, 022328
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Bucharest, Rumænien, 030171
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Cluj Napoca, Rumænien, 400015
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Bihor
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Oradea, Bihor, Rumænien, 410469
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Cluj
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Cluj-Napoca, Cluj, Rumænien, 400058
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Timis
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Timisoara, Timis, Rumænien, 300167
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A Coruna, Spanien, 15006
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Alicante, Spanien, 03010
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Barcelona, Spanien, 08036
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Barcelona, Spanien, 08916
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Barcelona, Spanien, 8028
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Barcelona, Spanien, 8035
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Burgos, Spanien, 09006
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Granada, Spanien, 18014
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Madrid, Spanien, 28034
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Madrid, Spanien, 28040
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Madrid, Spanien, 28041
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Madrid, Spanien, 28046
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Malaga, Spanien, 29010
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Palma de Mallorca, Spanien, 07198
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Seville, Spanien, 41013
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Valencia, Spanien, 46010
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Valencia, Spanien, 46026
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Zaragoza, Spanien, 50009
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Asturias
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Oviedo, Asturias, Spanien, 33006
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Cantabria
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Santander, Cantabria, Spanien, 39008
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Santa Cruz De Tenerife
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La Laguna, Santa Cruz De Tenerife, Spanien, 38320
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Linköping, Sverige, 581 85
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Lund, Sverige, 22185
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Stockholm, Sverige, 171 76
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Orebro Lan
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Örebro, Orebro Lan, Sverige, SE-70185
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Stockholms Lan
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Stockholm, Stockholms Lan, Sverige, 17176
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Vastra Gotalands Lan
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Goteborg, Vastra Gotalands Lan, Sverige, 41345
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Budapest, Ungarn, 1121
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Budapest, Ungarn, 1125
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Debrecen, Ungarn, 4032
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Baranya
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Pécs, Baranya, Ungarn, 7624
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Salzburg, Østrig, 5020
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Wien, Østrig, 1140
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Oberösterreich
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Wels, Oberösterreich, Østrig, 4600
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Cohort A: Treatment - Nivolumab
Nivolumab IV infusion
|
Hvad måler undersøgelsen?
Primære resultatmål
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
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)
|
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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)
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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)
|
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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
Sponsor
Sponsor
Samarbejdspartnere
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Immune Checkpoint-hæmmere
- Nivolumab
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- CA209-171
- 2014-001285-10 (EudraCT nummer)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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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