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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 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

12

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • België
      • Gent, België, 9000
        • AZ Maria Middelares
  • Spanje
      • Barcelona, Spanje, 08028
        • Hosp. Univ. Quiron Dexeus
      • Elche, Spanje, 03203
        • Hosp. Gral. Univ. de Elche
      • Jaén, Spanje, 23007
        • Complejo Hospitalario de Jaén
      • Málaga, Spanje, 29010
        • Hosp. Regional Univ. de Malaga
      • Palma de Mallorca, Spanje, 07198
        • Hosp. Son Llatzer
      • Valencia, Spanje, 46015
        • Hosp. Arnau de Vilanova de Valencia
  • Verenigde Staten
    • Maryland
      • Baltimore, Maryland, Verenigde Staten, 21287
        • Johns Hopkins Medicine - The Sidney Kimmel Comprehensive Cancer Center
    • Tennessee
      • Nashville, Tennessee, Verenigde Staten, 37201
        • Tennessee Oncology, PLLC
    • Washington
      • Spokane, Washington, Verenigde Staten, 99208-1129
        • Medical Oncology Associates, PS

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Biologisch: JNJ-64041757
Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.
Andere namen:
  • JNJ-757
Geneesmiddel: Nivolumab
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
Actieve vergelijker: 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.
Geneesmiddel: Nivolumab
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1b: Percentage of Participants With Objective Response
Tijdsspanne: Up to 6.8 Months
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.
Up to 6.8 Months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1b: Duration of Objective Response (DOR)
Tijdsspanne: Up to 6.8 months
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.
Up to 6.8 months
Phase 1b: Number of Participants With Progression-free Survival (PFS) Event (Progressed or Died Before Progression)
Tijdsspanne: Up to 6.8 months
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.
Up to 6.8 months
Phase 1b: Number of Participants With Overall Survival (OS) Event (Died)
Tijdsspanne: Up to 6.8 months
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.
Up to 6.8 months
Phase 1b: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Tijdsspanne: Up to 6.8 months
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.
Up to 6.8 months
Phase 1b: Number of Participants With Positive Blood Culture
Tijdsspanne: Up to 6.8 months
Number of participants with surveillance cultures positive for listeriosis were reported.
Up to 6.8 months
Phase 1b: Number of Participants With Bacterial Shedding
Tijdsspanne: Up to 6.8 months
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.
Up to 6.8 months
Phase 1b: Serum Concentrations of Nivolumab
Tijdsspanne: Up to 6.8 months
Nivolumab serum concentrations were reported.
Up to 6.8 months
Phase 1b: Number of Participants With Anti-nivolumab Antibodies
Tijdsspanne: Up to 6.8 months
Number of participants with antibodies to nivolumab were reported.
Up to 6.8 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

2 januari 2018

Primaire voltooiing (Werkelijk)

9 oktober 2018

Studie voltooiing (Werkelijk)

9 oktober 2018

Studieregistratiedata

Eerst ingediend

30 november 2017

Eerst ingediend dat voldeed aan de QC-criteria

11 december 2017

Eerst geplaatst (Werkelijk)

13 december 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 december 2019

Laatste update ingediend die voldeed aan QC-criteria

23 november 2019

Laatst geverifieerd

1 november 2019

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CR108232
  • 2016-002543-41 (EudraCT-nummer)
  • 64041757LUC2002 (Andere identificatie: Janssen Research & Development, LLC)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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