None listed
Conditions
Interventions
Group 1 Type of group
Ipilimumab 5 mg/ml solution, Intravenous, 10 mg/kg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Group name:Group 2 Type of group
Placebo Solution, Intravenous, 0 mg, Every 3 weeks for up to 4 doses in the Induction Phase. Every 12 weeks in the Maintenance Phase. Up to 24 weeks in the Induction Phase. Treatment in the Maintenance Phase continues until total treatment period has reached three years,Treatment Stopping Criteria are met, withdrawal of consent, or study closure
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Sex/Gender
Male
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • The patient must be willing to give informed consent and have the ability to do so. • histological or cytological onfirmation of prostate adenocarcinoma; • Having been treated by orchiectomy or receiving an LH-RH analogue, and having a testosterone level 18 years of age or with the minimum age to grant their consent according to local regulations.
Exclusion criteria
Exclusion criteria: • Sexually active fertile men who do not use an effective contraceptive method if their partner is a woman of childbearing age (MEF). • Visceral metastases (in liver, lung or brain) are not allowed; • Autoimmune disease; Patients with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn´s disease, are excluded from this study. Patients with a history of symptomatic disease (eg, rheumatoid arthritis, autoimmune thyroiditis (for example, Hashimoto´s disease), autoimmune hepatitis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (for example, Wegener´s granulomatosis); Patients with motor neuropathy considered of autoimmune origin (eg, Guillain-Barre syndrome) are excluded from this study, patients with vitiligo are eligible to enter the study. • Less than 1 year since the resolution of a toxicity ^ Grade 2 related to pelvic therapy (for example, radiation enteritis); • Dementia, altered mental status or any psychiatric disorder that could impede the understanding or granting of informed consent or filling in questionnaires; • A serious uncontrolled medical disorder that, in the opinion of the investigator, could prevent the patient from receiving protocol therapy, • A previous active malignancy within the previous 3 years, except for focally curable tumors that apparently have been cured and do not need further therapy, such as basal or squamous cell skin tumors, superficial bladder cancer or breast carcinoma in if you • Known infection with HIV, hepatitis B virus or hepatitis C virus. • Inadequate hematological function, defined as an absolute neutrophil count (ANC) 2.5 times the upper limit of the normal range G ^ SN), AST and ALT levels> 2.5 times the LSN or> 5 times the LSN if there is liver metastasis ; • Inadequate renal function, defined by a serum creatinine level> 2.5 times the LSN; • inadequate creatinine learance, defined as a value less than 50 ml / min; • Previous treatment with any immunotherapy for prostate cancer, including the autologous vaccine against sipuleucel-T prostate cancer (Provenge); • Previous or ongoing cytotoxic therapy for metastatic prostate cancer (for example, docetaxel, mitoxantrone, estramustine); • pelvic adiotherapy within 3 months prior to the start of study therapy; • Chronic use of immunosuppressants and / or systemic corticosteroids (used in the management of cancer or non-cancer related diseases). However, during the course of the study, the use of corticosteroids will be allowed if they are used to treat IAS or adrenal insufficiencies; • Any therapy of non-cancer vaccines used for the prevention of infectious diseases (for up to 4 weeks before or after any dose of the study blind drug); • Previous treatment with any inhibitor or agonist of costimulation of T cells; • Previous therapy with radioisotopes (for example, strontium-89, samarium-153 or similar agents); • Inmates or individuals who are held against their will; • Individuals who are necessarily detained for the treatment of a psychiatric or physical illness (for example, for an infectious disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:OS was defined as the time from the date of randomization until the date of death. For participants without documentation of death, OS was censored at the last date the participant was known to be alive. Measure:Overall Survival (OS) Time Timepoints:Randomization until death from any cause, up to April 2015, approximately 57 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Progression-free survival, as determined by the investigator, was defined as the time from randomization to the earliest date of confirmed Prostate-Specific Antigen (PSA) progression, confirmed radiological progression, clinical deterioration, or death. Measure:Progression-Free Survival (PFS) Time Timepoints:Randomization until disease progression, up to April 2015, approximately 57 months ; Outcome name:For participants who discontinued treatment or experienced disease progression while on study therapy and then received subsequent non-hormonal cytotoxic therapy, time to subsequent non-hormonal cytotoxic therapy was defined as the time from randomization to the time of initiation of subsequent non-hormonal cytotoxic therapy. Participants who did not receive subsequent non-hormonal cytotoxic therapy were censored on the last known alive date (for participants who have not died) or the date of last follow-up contact at which the participants was known alive (for participants who died). Measure:Time to Subsequent Non-hormonal Cytotoxic Therapy Timepoints:Randomization until subsequent non-hormonal cytotoxic therapy, up to April 2015, approximately 57 months ; Outcome name:Time to pain progression was defined as the time from randomization to the time of the earliest date of any of the following 4 events: 1) an increase in average daily worst pain intensity of >= 2 points from baseline according to the Brief Pain Inventory - Short Form (BPI-SF), maintained over 2 consecutive time periods. 2) initiation of opioid analgesic (excluding codeine or dextropropoxyphene). 3) initiation of palliative radiotherapy for prostate cancer. 4) increase in mean Analgesic Score (AS) of >= 25% from baseline (for participants with baseline AS > 10) or increase in mean AS >= 10 points from baseline (for participants with baseline AS 2.0 - 5.0 * ULN; Gr 4: > 5.0 X ULN. Amylase: Gr 3: > 2.0 - 5.0 * ULN; Gr 4: > 5.0 * ULN. Alanine Aminotransferase | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, France, Germany, Greece, Hungaria, India, Italy, Mexico, Netherlands, Norway, Poland, Romania, Russian Federation, Spain, Sweden, Turkey, United Kindgdom, United States
Contacts
Public ContactUrsula Noto
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed