Randomized, Double-Blind, Phase III Trial of Ipilimumab Versus Placebo in Asymptomatic or Minimally Symptomatic Patients With Metastatic Chemotherapy-Naive Castration-Resistant Prostate Cancer
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"Randomized, Double-Blind, Phase III..." refers background in this paper
...Of note, approximately 20% of ipilimumabtreated patients with melanoma experienced long-term survival.(17,18,20-26) Results of a phase I/II dose-finding study of ipilimumab in 71 chemotherapy-naive or chemotherapy-pretreated patients with metastatic CRPC (mCRPC) showed antitumor activity in this clinical setting, with durable prostate-specific antigen (PSA) responses independent of prior chemotherapy, which supports further ipilimumab evaluation in phase III studies....
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...5 3 ULN 72 (18) 26 (13) Not reported 1 (, 1) 0 Gleason score # 7 189 (47) 103 (51) $ 8 192 (48) 91 (45) Not reported 19 (5) 8 (4) PSA Patients with available PSA data 393 197...
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...Ipilimumab is a fully human monoclonal immunoglobulin G1 antibody that increases antitumor T-cell responses by binding to.(17-19) Blocking by ipilimumab of the T-cell negative regulator cytotoxic T-lymphocyte antigen-4 allows CD28 and B7 interactions, which result in T-cell activation; proliferation; tumor infiltration; and ultimately, cancer cell death....
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4,840 citations
"Randomized, Double-Blind, Phase III..." refers background in this paper
...clinical activity of sipuleucel-T, a cellular immunotherapy based on ex vivo–activated peripheral mononuclear cells.(11-16) Ipilimumab is a fully human monoclonal immunoglobulin G1 antibody that increases antitumor T-cell responses by binding to....
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4,069 citations
"Randomized, Double-Blind, Phase III..." refers background in this paper
...Of note, approximately 20% of ipilimumabtreated patients with melanoma experienced long-term survival.(17,18,20-26) Results of a phase I/II dose-finding study of ipilimumab in 71 chemotherapy-naive or chemotherapy-pretreated patients with metastatic CRPC (mCRPC) showed antitumor activity in this clinical setting, with durable prostate-specific antigen (PSA) responses independent of prior chemotherapy, which supports further ipilimumab evaluation in phase III studies....
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...01-9,297) Bone metastases Yes 312 (78) 159 (79) No 85 (21) 39 (19) Not reported 3 (, 1) 4 (2) Average daily worst bone pain intensity score None 215 (54) 109 (54) Minimal 179 (45) 90 (45) Not reported 6 (, 2) 3 (2) Bisphosphonate use Yes 99 (25) 62 (31) No 301 (75) 140 (69)...
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3,866 citations
"Randomized, Double-Blind, Phase III..." refers background in this paper
...Although significant treatment advances have been made recently with the introduction of novel therapeutic agents, such as enzalutamide, abiraterone acetate, cabazitaxel, and radium 223, prognosis and long-term outcomes for patients with castration-resistant prostate cancer (CRPC) need to be improved.(2-8) The presence of inflammatory cells and T-cell infiltrates in prostate cancer tissues suggest that host inflammatory/immune effectors may reach these tumors and mediate antitumor responses....
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...of patients 400 202 Median age, years (range) 70 (44-91) 69 (42-92) Age-group , 65 years 104 (26) 65 (32) $ 65 years 296 (74) 137 (68) Race White 361 (90) 185 (92) Black 20 (5) 11 (5) Asian 4 (1) 2 (1) American Indian/Alaskan 2 (, 1) 1 (, 1) Native Hawaiian/Pacific Islander 1 (, 1) 0 Other 12 (3) 3 (2) Region United States/Canada 136 (34) 70 (35) Not United States/Canada 264 (66) 132 (65) ECOG performance status 0 299 (75) 151 (75) 1 100 (25) 51 (25) 2 1 (, 1) 0 Lactate dehydrogenase level , 200 IU/L 250 (63) 130 (64) $ 200 IU/L 149 (37) 72(36) Not reported 1 (, 1) 0 Hemoglobin concentration , 11 g/dL 31 (8) 14 (7) $ 11 g/dL 364 (91) 183 (91) Not reported 5 (1) 5 (3) Measurable disease Yes 169 (42) 96 (48) No 228 (57) 102 (51) Not reported 3 (, 1) 4 (2) Alkaline phosphatase level , 1....
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...01-9,297) Bone metastases Yes 312 (78) 159 (79) No 85 (21) 39 (19) Not reported 3 (, 1) 4 (2) Average daily worst bone pain intensity score None 215 (54) 109 (54) Minimal 179 (45) 90 (45) Not reported 6 (, 2) 3 (2) Bisphosphonate use Yes 99 (25) 62 (31) No 301 (75) 140 (69)...
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