Metastatik Kastrasyona Dirençli Prostat Kanseri Olan Katılımcılarda Canlı Zayıflatılmış Çift Delesyonlu Listeria İmmünoterapisi JNJ-64041809'un Güvenliliği ve İmmünojenisitesi

Sade dilde özet

Bu çalışma, canlı zayıflatılmış bir Listeria bakterisinden geliştirilen JNJ-64041809 adlı immünoterapinin güvenliliğini ve bağışıklık sistemini uyarma özelliğini (immünojenisite) incelemektedir. Metastatik kastrasyona dirençli prostat kanseri (metastatic castration-resistant prostate cancer) olan ve daha önce en az iki onaylı tedavi almış hastalar katılabilmektedir. Çalışma Faz 1 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Tamamlandı

Sponsor

Janssen Research & Development, LLC

Müdahale

JNJ-64041809 (Cohort 1A and 1B), JNJ-64041809 (Cohort 2A and 2B)

Başlangıç

10.12.2015

Tahmini bitiş

03.07.2018

Ülkeler

United States

İlgili genler

Merkezler

• San Francisco, United States
• Baltimore, United States
• St Louis, United States
• Nashville, United States
• Houston, United States
• Madison, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate with progressive metastatic disease which, in the opinion of the investigator, requires initiation of new treatment. The assessment of disease progression can be based on either PSA rise, new or progressive soft tissue disease (based on computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scans), or new or progressive bony disease based on radionuclide bone scan or 18F-sodium fluoride positron emission tomography/computed tomography \[NaF PET/CT\] scans). Participants being considered for Cohort 2B must, in addition, have primary or metastatic lesions amenable to tumor biopsies
* Must have received at least 2 prior approved therapies
* Ongoing androgen depletion therapy with a Gonadotropin Releasing Hormone analog or inhibitor, or orchiectomy (surgical or medical castration)
* Serum testosterone levels less than (\<) 50 nanogram per deciliter (ng/dL) determined within 4 weeks prior to start of study drug
* For participants previously treated with first generation anti-androgens (ie, flutamide, nilutamide, or bicalutamide), discontinuation of flutamide or nilutamide therapy must occur greater than (\>) 4 weeks (\>6 weeks for bicalutamide) prior to start of study drug with no evidence of an anti-androgen withdrawal response (no decline in serum PSA)

Exclusion Criteria:

* Untreated brain metastases. Participants must have completed treatment for brain metastasis, and be neurologically stable off steroids, for at least 28 days prior to first dose of study drug
* Untreated spinal cord compression
* History of listeriosis or vaccination with a listeria-based vaccine or prophylactic vaccine (example influenza, pneumococcal, diphtheria, tetanus, and pertussis \[dTP/dTAP\]) within 28 days of study treatment
* Known allergy to both penicillin and trimethoprim/sulfamethoxazole. Participants who are allergic to only one of these antibiotics are allowed to enroll
* Concurrent treatment with anti -Tumor necrosis factor (TNF) alpha therapies, systemic corticosteroids (prednisone dose \>10 mg per day or equivalent) or other immune suppressive drugs within the 2 weeks prior to Screening. Steroids that are topical, inhaled, nasal (spray), or ophthalmic solution are permitted