Active, Not Recruiting
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer - CA209-7DX
Uppdaterad:
12 januari, 2024
|
ClinicalTrials.gov
Fas
Kön
Åldersintervall
Active, Not Recruiting
For more information regarding Bristol Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologic confirmation of adenocarcinoma of the prostate and evidence of stage IV disease - Must have ECOG performance status 0-1 - Documented prostate cancer progression per PCWG3 criteria within 6 months prior to screening - Ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or bilateral orchiectomy - Participants who are chemotherapy-naive and received 1 to 2 prior second generation hormonal therapies - Sufficient tumor sample from fresh or archival tumor tissue obtained no more than 1 year prior to enrollment, from a metastatic lesion or primary tumor lesion that has not been previously irradiated Exclusion Criteria: - Participants with active brain metastases - Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured - Participants with an active, known, or suspected autoimmune disease - Participants requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications - Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or any antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways - Prior treatment with docetaxel or another chemotherapy for metastatic castration resistant prostate cancer Other protocol defined inclusion/exclusion criteria could apply
Vi rekommenderar att du kontaktar BMS för att rapportera biverkningar.
Biverkningar (oönskade händelser) och andra rapporterbara händelser definieras här
För att rapportera biverkningar (oönskade händelser) eller reklamera ett läkemedel: Medicinsk information
466-SE-2100058