Study of Immunotherapy to Treat Advanced Prostate Cancer

• Conditions: Castration Resistant Prostate Cancer; MedDRA version: 16.1Level: PTClassification code 10060862Term: Prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2008-003314-97-NL
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05-25
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1000

Inclusion Criteria

1) Signed Written Informed Consent
a) Willing and able to give informed consent.

2) Target Population
a) Histologic or cytologic confirmation of adenocarcinoma of the prostate;
Note: Every effort should be made to obtain the original pathology report diagnosing prostate cancer. If the original pathology report cannot be obtained then written documentation, in the form of a letter from the referring physician or a clinic note from the CA184043 investigator, must be entered into the subject’s medical record.
b) At least 1 symptomatic bone metastasis which can be irradiated, or at least 1 asymptomatic bone metastasis which, in the clinical judgment of the investigator, is appropriate to be irradiated (eg, risk of fracture or cord compression);
c) Have been treated by orchiectomy or are receiving a GnRH agonist/antagonist, and have a testosterone level less than 50 ng/dl (1.74 nmol/L);
d) If applicable, must have discontinued anti-androgens at least 2 weeks prior to randomization. Medications considered to be anti-androgens include; Flutamide, Bicalutamide (Casodex), nilutamide, aminoglutethimide, ketoconazole, diethylstilbestrol, megestrol acetate (Megace), and finasteride (Proscar). Additionally, any natural substance that might have anti-androgen activity, including but not limited to St John’s Wort, Saw Palmetto, or PC-SPES, must be discontinued prior to randomization;
e) Must have received at least 1 prior regimen containing docetaxel for the treatment of metastatic CRPC, consisting of at least 2 cycles of docetaxel;
f) ECOG Performance Status: Subjects must have ECOG PS 0 - 1.
g) Subjects must have progressed while receiving, or within 6 months of receiving, a
docetaxel-containing regimen. If the subject received additional anti-cancer
therapy after docetaxel, they must also demonstrate signs of progression on that
therapy. For eligibility purposes, progressive disease is defined by any one of the
following;
i) Rising PSA values at a minimum of 1-week intervals and a 2.0 ng/mL
minimum starting value
ii) Progression per bone scan: the appearance of 2 or more new lesions
iii) Progression per target lesions/measurable disease: nodal or visceral disease
progression, per modified RECIST. Only lymph nodes greater than 2 cm will
be considered to assess a change in size qualifying for disease progression.

3) Age and Sex
a) Men = 18 years of age or minimum age of consent per local regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Sex and Reproductive Status
a) Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential (WOCBP).

2) Target Disease Exceptions
a) History of brain metastasis.

3) Medical History and Concurrent Diseases
a) Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease are excluded from this study, as are subjects with a history of rheumatoid arthritis, systemic progressive sclerosis (scleroderma), Systemic Lupus Erythematosus, autoimmune vasculitis (eg, Wegener’s Granulomatosis);
b) Motor neuropathy considered of autoimmune origin (eg, Guillain-Barre Syndrome);
c) Patients with a prior history of pelvic (prostate) radiation associated with significant radiation proctitis within 12 months prior to the planned first infusion of blinded study drug. For the purpose of this protocol, radiation proctitis is defined as diarrhea that reached a level of Grade 2 or Grade 3, that occurred within 1 month of radiation treatment, and that was of 7 days duration or longer.
d) Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent or completing questionnaires;
e) A serious uncontrolled medical disorder that, in the opinion of the investigator, would impair the ability of the subject to receive protocol therapy;
f) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured and needing no subsequent therapy, such as basal or squamous cell skin cancer, or superficial bladder cancer;
g) Known HIV or Hepatitis B or Hepatitis C infection, based on testing performed
during the CA184043 screening period.

4) Physical and Laboratory Test Findings
a) Inadequate hematologic function defined by an absolute neutrophil count (ANC) < 1,500/mm³, a platelet count < 100,000/mm³, or a hemoglobin level < 9 g/dL;
b) Inadequate hepatic function defined by a total bilirubin level = 2.5 times the upper limit of normal (ULN), AST and ALT levels = 2.5 times the ULN or = 5 times the ULN if liver metastases are present;
c) Inadequate renal function defined by a serum creatinine level = 2.5 times the ULN;
d) Inadequate creatinine clearance defined as less than 50 mL/min;
e) Usage of greater than 120 mg of oral morphine (or equivalent) over a 24 hour period within 3 days of randomization, unless narcotic usage is necessitated by a symptomatic bone lesion that is likely to be palliated by protocol-specified radiotherapy.

5) Prohibited Treatments and/or Therapies
a) More than 2 prior cytotoxic chemotherapy regimens for metastatic CRPC. Note: for purposes of eligibility, all docetaxel-containing regimens are considered to be one regimen.
b) Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses). However, during the course of the study, use of corticosteroids is allowed if used for treating irAEs, or adrenal insufficiencies, or if administered at doses of prednisone 5 mg BID or equivalent;
c) Any non-oncology vaccine therapy used for the prevention of infectious diseases (for up to 4 weeks prior to or after any dose of blinded study drug);
d) Prior treatment with any inhibitor or agonist of T cell costimulation;
e) Prior strontium or samarium;
f) Prior treatment on BMS study CA180227: A Randomized Double-Blind

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified