- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03371381
An Efficacy and Safety Study of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Participants With Advanced Adenocarcinoma of the Lung
23. november 2019 opdateret af: Janssen Research & Development, LLC
An Open-Label Randomized Phase 1b/2 Study of the Efficacy and Safety of JNJ-64041757, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Nivolumab Versus Nivolumab Monotherapy in Subjects With Advanced Adenocarcinoma of the Lung
The purpose of this study is to evaluate whether the efficacy of JNJ-757 combined with nivolumab is better than the efficacy of nivolumab monotherapy for participants with mesothelin-positive relapsed/refractory Stage IIIB or Stage IV adenocarcinoma of the lung.
The open-label study comprises of two parts i.e.
Phase 1b (safety run-in) and Phase 2. Phase1b consists of 1 arm whereas Phase 2 is randomized into 2 groups i.e.
Group A and Group B.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This study evaluates safety and efficacy of JNJ-64041757 with nivolumab.
The total study duration will be up to 3 years.
It will consist of safety run-in and randomized phase which will comprise of Screening phase(Day(D) -28 to D -1),Treatment Phase,End of Adverse Event Evaluation Period (100 D after last dose of nivolumab)and Post-treatment Follow-up Phase(Every 3 Months).
The primary hypothesis is that addition of JNJ-640417577 to nivolumab will result in higher objective response rate compared with nivolumab monotherapy in at least one of programmed death receptor ligand 1 subgroups in participants with relapsed or refractory StageIIIB or StageIV adenocarcinoma of lung.
The study procedures include blood culture bacterial shedding assessments, pharmacokinetics, immunogenicity, and biomarkers.
Safety will be monitored throughout study.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
12
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Gent, Belgien, 9000
- AZ Maria Middelares
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37201
- Tennessee Oncology, PLLC
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Washington
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Spokane, Washington, Forenede Stater, 99208-1129
- Medical Oncology Associates, PS
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Barcelona, Spanien, 08028
- Hosp. Univ. Quiron Dexeus
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Elche, Spanien, 03203
- Hosp. Gral. Univ. de Elche
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Jaén, Spanien, 23007
- Complejo Hospitalario de Jaén
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Málaga, Spanien, 29010
- Hosp. Regional Univ. de Malaga
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Palma de Mallorca, Spanien, 07198
- Hosp. Son Llatzer
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Valencia, Spanien, 46015
- Hosp. Arnau de Vilanova de Valencia
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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:
- Disease-related criteria: Histologically documented adenocarcinoma of the lung; Stage IIIB or Stage IV disease; Biopsy material available for central assessment of programmed death receptor ligand 1 (PD-L1) and mesothelin
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Progressive disease during or after platinum-based doublet chemotherapy
- A woman of childbearing potential must have a negative serum or urine pregnancy test within 14 days before the first dose of nivolumab
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
Exclusion Criteria:
- Tumor with activating epidermal growth factor receptor (EGFR) mutation or ALK translocation
- More than 1 prior line of chemotherapy for metastatic disease (Phase 2)
- History of disallowed therapies, as follows: In Phase 1b only: Prior exposure to anti-programmed death receptor-1(PD1), anti programmed death receptor ligand 1 (PD-L1), anti-programmed death receptor ligand 2 (PD-L2), anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibody within 28 days before the first dose of study agent, In Phase 2 only: Prior exposure to anti-PD1, anti PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T lymphocyte associated antigen 4 (CTLA-4) antibody, History of listeriosis or vaccination with a Listeria-based vaccine or prophylactic vaccine within 28 days before the first dose of study agent, Chemotherapy within 28 days before the first dose of study agent, Radiation within 14 days before the first dose of study agent
- History of any other condition that may require the initiation of anti-tumor necrosis factor alpha (TNF alpha) therapies or other immunosuppressant medications during the study
- Active second malignancy within 2 years prior to Cycle 1 Day 1 (Phase 1b) or randomization (Phase 2)
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 |
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Eksperimentel: Nivolumab + JNJ-64041757
Phase 1b and Phase 2 Group A/Arm 1: Participants will receive separate intravenous (IV) infusions of nivolumab and JNJ-64041757 over approximately 60 minutes during each treatment cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.
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Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.
Andre navne:
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
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Aktiv komparator: Nivolumab
Phase 2 Group B/Arm 2: Participants will receive intravenous (IV) infusions of nivolumab over approximately 60 minutes during each treatment cycle until disease progression, unacceptable toxicity, protocol violation requiring discontinuation of study treatment, withdrawal of consent, noncompliance with study procedures, or the sponsor terminates the study.
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Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Phase 1b: Percentage of Participants With Objective Response
Tidsramme: Up to 6.8 Months
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Objective response rate was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
RECIST for CR - disappearance of all lesions; all lymph nodes were non-pathological in size and normalization of tumor marker level; PR - greater than or equal to (>=) 30 percent (%) decrease in the sum of the diameters of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of nontarget lesions.
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Up to 6.8 Months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Phase 1b: Duration of Objective Response (DOR)
Tidsramme: Up to 6.8 months
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Duration of objective response was defined as the time from initial documentation of a response (CR or PR) to first documented date of disease progression (PD) or death from any cause.
RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum).
Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is stable disease [SD]/PR).
Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease.
Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion.
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Up to 6.8 months
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Phase 1b: Number of Participants With Progression-free Survival (PFS) Event (Progressed or Died Before Progression)
Tidsramme: Up to 6.8 months
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Number of participants with PFS event (progressed or died before progression) were reported.
PFS - time from date of randomization until date of first documented evidence of PD (or relapse for participants who experience CR during study) or death from any cause, whichever comes first.
RECIST for PD - sum of diameters had increased by >= 20% and >=5 mm from nadir (including baseline if it was smallest sum).
Participants with measurable disease: for "unequivocal progression" based on non-target disease, there was an overall level of substantial worsening that merits discontinuation of therapy (if target disease is SD/PR).
Participants without measurable disease: for "unequivocal progression" of non-target disease, increase in overall tumor burden must be comparable to increase required for PD of measurable disease.
Furthermore, appearance of 1 or more new lesions or unequivocal progression of a non-target lesion.
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Up to 6.8 months
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Phase 1b: Number of Participants With Overall Survival (OS) Event (Died)
Tidsramme: Up to 6.8 months
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Number of participants with OS event (died) were reported.
Overall Survival was defined as the duration from the date of randomization to the date of participant's death due to any cause.
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Up to 6.8 months
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Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to 6.8 months
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An adverse event is any untoward medical event that occurs in a participant administered an investigational product and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
TEAEs are defined as adverse events with onset or worsening on or after date of first dose of study treatment.
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Up to 6.8 months
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Phase 1b: Number of Participants With Positive Blood Culture
Tidsramme: Up to 6.8 months
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Number of participants with surveillance cultures positive for listeriosis were reported.
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Up to 6.8 months
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Phase 1b: Number of Participants With Bacterial Shedding
Tidsramme: Up to 6.8 months
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Number of participants with bacterial shedding were reported.
The shedding of JNJ-64041757 was studied in feces by stool or rectal swab, urine and saliva.
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Up to 6.8 months
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Phase 1b: Serum Concentrations of Nivolumab
Tidsramme: Up to 6.8 months
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Nivolumab serum concentrations were reported.
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Up to 6.8 months
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Phase 1b: Number of Participants With Anti-nivolumab Antibodies
Tidsramme: Up to 6.8 months
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Number of participants with antibodies to nivolumab were reported.
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Up to 6.8 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
2. januar 2018
Primær færdiggørelse (Faktiske)
9. oktober 2018
Studieafslutning (Faktiske)
9. oktober 2018
Datoer for studieregistrering
Først indsendt
30. november 2017
Først indsendt, der opfyldte QC-kriterier
11. december 2017
Først opslået (Faktiske)
13. december 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. november 2019
Sidst verificeret
1. november 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Lungeneoplasmer
- Adenocarcinom
- Adenocarcinom i lunge
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Immune Checkpoint-hæmmere
- Nivolumab
Andre undersøgelses-id-numre
- CR108232
- 2016-002543-41 (EudraCT nummer)
- 64041757LUC2002 (Anden identifikator: Janssen Research & Development, LLC)
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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