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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 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

12

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

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

Studiesteder

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

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

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

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Biologisk: JNJ-64041757
Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.
Andre navn:
  • JNJ-757
Legemiddel: Nivolumab
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
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.
Legemiddel: Nivolumab
Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase 1b: Percentage of Participants With Objective Response
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Phase 1b: Duration of Objective Response (DOR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 6.8 months
Nivolumab serum concentrations were reported.
Up to 6.8 months
Phase 1b: Number of Participants With Anti-nivolumab Antibodies
Tidsramme: Up to 6.8 months
Number of participants with antibodies to nivolumab were reported.
Up to 6.8 months

Samarbeidspartnere og etterforskere

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

Sponsor

Janssen Research & Development, LLC

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)

2. januar 2018

Primær fullføring (Faktiske)

9. oktober 2018

Studiet fullført (Faktiske)

9. oktober 2018

Datoer for studieregistrering

Først innsendt

30. november 2017

Først innsendt som oppfylte QC-kriteriene

11. desember 2017

Først lagt ut (Faktiske)

13. desember 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. desember 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. november 2019

Sist bekreftet

1. november 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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Sponsorer og samarbeidspartnere

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CROs in Japan

Forhold

Sjeldne sykdommer

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