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1 ivolumab plus ipilimumab, 37% nivolumab, 15% ipilimumab).
2 b plus ipilimumab compared with nivolumab or ipilimumab.
3 as a biomarker for first-line nivolumab plus ipilimumab.
4 mbrolizumab in combination with reduced-dose ipilimumab.
5 1 of 44 patients escalated to anti-PD-1 plus ipilimumab.
6 ty without additional safety concerns versus ipilimumab.
7 e progression while receiving treatment with ipilimumab.
8 tastasis-free survival with nivolumab versus ipilimumab.
9 , and 59.2% (95% CI 51.7-66.8) for nivolumab/ipilimumab.
10 profile that is more tolerable than that of ipilimumab.
11 h metastatic malignant melanoma treated with ipilimumab.
12 tumor activity alone and in combination with ipilimumab.
13 for death with nivolumab plus ipilimumab vs. ipilimumab, 0.52; hazard ratio for death with nivolumab
14 for death with nivolumab plus ipilimumab vs. ipilimumab, 0.55 [P<0.001]; hazard ratio for death with
17 oup fixed brentuximab vedotin 1.8 mg/kg with ipilimumab 1 mg/kg (cohort A) or 3 mg/kg (cohort B); in
18 received intravenous nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (N3I1), nivolumab 1 mg/kg plus ipilim
19 511) to determine if nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (NIVO3+IPI1) improves the safety prof
20 weeks, nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 12 weeks, or nivolumab 3 mg/kg
21 very 2 weeks (NIVO3), nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed
22 d (1:1) to open-label nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed
23 enous pembrolizumab 2 mg/kg plus intravenous ipilimumab 1 mg/kg every 3 weeks for four doses, followe
24 eks, or nivolumab 3 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks until disease progressi
25 receive nivolumab 1 mg/kg every 2 weeks plus ipilimumab 1 mg/kg every 6 weeks, nivolumab 3 mg/kg ever
27 et therapy group fixed nivolumab 3 mg/kg and ipilimumab 1 mg/kg with brentuximab vedotin 1.2 mg/kg (c
28 label nivolumab (3 mg/kg intravenously) plus ipilimumab (1 mg/kg intravenously) every 3 weeks for fou
29 ients were enrolled and randomly assigned to ipilimumab 10 mg/kg (365 patients; 364 treated) or ipili
30 vival was 15.7 months (95% CI 11.6-17.8) for ipilimumab 10 mg/kg compared with 11.5 months (9.9-13.3)
31 atment-related grade 3-4 adverse events with ipilimumab 10 mg/kg compared with ipilimumab 3 mg/kg in
32 volumab 3 mg/kg every 2 weeks or intravenous ipilimumab 10 mg/kg every 3 weeks for four doses, and th
33 ow-up was 14.5 months (IQR 4.6-42.3) for the ipilimumab 10 mg/kg group and 11.2 months (4.9-29.4) for
34 permuted block method using block size 4 to ipilimumab 10 mg/kg or 3 mg/kg, administered by intraven
35 ive voice response system, to receive either ipilimumab 10 mg/kg or placebo every 3 weeks for four do
36 al, patients were randomly assigned (2:1) to ipilimumab 10 mg/kg or placebo every 3 weeks for up to f
38 ETATION: In patients with advanced melanoma, ipilimumab 10 mg/kg resulted in significantly longer ove
40 icted mean TFS was longer for nivolumab plus ipilimumab (11.1 months) compared with nivolumab (4.6 mo
43 /kg compared with 11.5 months (9.9-13.3) for ipilimumab 3 mg/kg (hazard ratio 0.84, 95% CI 0.70-0.99;
44 mumab 1 mg/kg (N3I1), nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (N1I3), or nivolumab 3 mg/kg plus ipi
45 ab 3 mg/kg (N1I3), or nivolumab 3 mg/kg plus ipilimumab 3 mg/kg (N3I3) every 3 weeks for four doses f
47 eeks (NIVO3+IPI1), or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four doses followed
48 at least one dose of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks x 4 and then nivolumab
52 vents with ipilimumab 10 mg/kg compared with ipilimumab 3 mg/kg in patients with advanced melanoma.
53 gnificantly longer overall survival than did ipilimumab 3 mg/kg, but with increased treatment-related
54 patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, follow
56 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four dos
57 se of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four do
61 h nivolumab and 50.9 months (36.2-52.3) with ipilimumab; 4-year recurrence-free survival was 51.7% (9
62 e, 6.5 months; 95% CI, 5.0 to 8.0 months) or ipilimumab (8.7 months; difference, 2.4 months; 95% CI,
63 heckpoint inhibitor), alone or combined with ipilimumab (a cytotoxic T-lymphocyte antigen-4 checkpoin
64 most patients during the induction phase of ipilimumab administration, overall HRQoL, as measured by
67 weeks; up to four doses) began week 1 in the ipilimumab alone arm and week 6 in the combination arm.
68 al and a higher objective response rate than ipilimumab alone in a phase 3 trial involving patients w
69 r progression-free and overall survival than ipilimumab alone in a trial involving patients with adva
70 imogene laherparepvec plus ipilimumab versus ipilimumab alone in patients with advanced melanoma in a
71 mumab alone, 42%), chills (combination, 53%; ipilimumab alone, 3%), and diarrhea (combination, 42%; i
73 ts (AEs) included fatigue (combination, 59%; ipilimumab alone, 42%), chills (combination, 53%; ipilim
75 r nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of li
81 r hundred patients were randomly assigned to ipilimumab and 202 to placebo; 399 were treated with ipi
82 07 (95% CI 4.35 to 15.80) for nivolumab plus ipilimumab and 6.40 (-1.36 to 14.16) for sunitinib (p=0.
83 ple of prostate cancer subjects treated with Ipilimumab and granulocyte macrophage colony stimulating
84 relapse showed significantly higher rates of ipilimumab and ipilimumab/anti-programmed death 1 use in
85 anoma who developed fatal myocarditis during ipilimumab and nivolumab combination immunotherapy; thes
87 he safety and activity of the combination of ipilimumab and nivolumab in patients who have received p
90 he median progression-free survival while on ipilimumab and nivolumab was 4 months (range, 0.8-19 mon
92 ted adverse events (irAEs) of any grade with ipilimumab and nivolumab were recorded in 29 (64%) of th
95 t-related AEs was higher with nivolumab plus ipilimumab and occurred earlier than historical experien
96 ndicating that direct steric overlap between ipilimumab and the B7 ligands is a major mechanistic con
97 [SD 17.05] for placebo vs 18.17 [28.35] for ipilimumab) and insomnia (15.17 [22.53] vs 25.60 [29.19]
99 immune-related AE, were 8209 per 100 000 for ipilimumab (anti-CTLA-4), 2542 per 100 000 for nivolumab
102 olumab (anti-programmed death-1 antibody) to ipilimumab (anti-cytotoxic T-cell lymphocyte-associated
103 significantly higher rates of ipilimumab and ipilimumab/anti-programmed death 1 use in the HDI arm ve
105 combination arm and 18 patients (18%) in the ipilimumab arm had an objective response (odds ratio, 2.
106 gression-free survival was 5.6 months in the ipilimumab arm versus 3.8 with placebo arm (hazard ratio
113 ficacy and safety of nivolumab plus low-dose ipilimumab as first-line treatment of advanced/metastati
114 067 and 069 clinical trials of nivolumab and ipilimumab, as monotherapies or in combination, for pati
117 ose of 1 mg per kilogram of body weight plus ipilimumab at a dose of 3 mg per kilogram every 3 weeks
118 per kilogram every 2 weeks plus placebo; or ipilimumab at a dose of 3 mg per kilogram every 3 weeks
119 b and nivolumab (CaboNivo) and CaboNivo plus ipilimumab (CaboNivoIpi) in patients with metastatic uro
123 fficacy endpoints showed that nivolumab plus ipilimumab continued to be superior to sunitinib in term
124 The combination regimen of nivolumab plus ipilimumab demonstrates activity in metastatic uveal mel
128 atients received all four pembrolizumab plus ipilimumab doses; 64 (42%) remained on pembrolizumab mon
129 vanced cancers treated with nivolumab and/or ipilimumab, everolimus or docetaxel in phase 3 clinical
130 gned to receive nivolumab every 2 weeks plus ipilimumab every 12 weeks (n=38) or nivolumab every 2 we
131 izumab every 3 weeks (n=277), or intravenous ipilimumab every 3 weeks (ipilimumab for four doses; n=2
132 ab every 3 weeks plus 3 mg/kg of intravenous ipilimumab every 3 weeks for four doses, followed by 3 m
134 ts were reported in 12 (32%) patients in the ipilimumab every-12-weeks cohort and 11 (28%) patients i
135 p times of 12.8 months (IQR 9.3-15.5) in the ipilimumab every-12-weeks cohort and 11.8 months (6.7-15
136 events occurred in 14 (37%) patients in the ipilimumab every-12-weeks cohort and 13 (33%) patients i
137 e achieved in 12 (57%) of 21 patients in the ipilimumab every-12-weeks cohort and 13 (57%) of 23 pati
138 d in 18 (47% [95% CI 31-64]) patients in the ipilimumab every-12-weeks cohort and 15 (38% [95% CI 23-
139 off on Jan 7, 2016, 29 (76%) patients in the ipilimumab every-12-weeks cohort and 32 (82%) in the ipi
140 ients actually received treatment (38 in the ipilimumab every-12-weeks cohort; 39 in the ipilimumab e
141 ab every-12-weeks cohort and 32 (82%) in the ipilimumab every-6-weeks cohort had discontinued treatme
146 and 15 (38% [95% CI 23-55]) patients in the ipilimumab every-6-weeks cohort; median duration of resp
147 combination with four doses of reduced-dose ipilimumab followed by standard-dose pembrolizumab has a
148 ry 2 weeks) or induction with nivolumab plus ipilimumab for 4 doses (every 3 weeks), followed by ever
149 ies evaluated durvalumab, and nivolumab plus ipilimumab for anti-PD-1 or anti-PD-L1-naive disease, an
151 he same event and five (3%) who discontinued ipilimumab for one event and later discontinued pembroli
154 active, online system, to the nivolumab plus ipilimumab group (1 mg/kg of intravenous nivolumab every
155 nivolumab group and 41.2% (36.4-45.9) in the ipilimumab group (hazard ratio [HR] 0.71 [95% CI 0.60-0.
156 ab groups and 15.9 months (13.3-22.0) in the ipilimumab group (hazard ratio [HR] 0.73, 95% CI 0.61-0.
157 b group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab
158 b group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab
159 ab groups versus 3.4 months (2.9-4.2) in the ipilimumab group (HR 0.57, 95% CI 0.48-0.67, p<0.0001).
160 b group and 16 (31.4%) in the nivolumab plus ipilimumab group (odds ratio, 3.28; 85% CI, 1.54 to infi
161 s (median not reached) in the nivolumab-plus-ipilimumab group and 36.9 months in the nivolumab group,
162 val at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as comp
164 ate at 3 years was 58% in the nivolumab-plus-ipilimumab group and 52% in the nivolumab group, as comp
165 s, ipilimumab was given every 6 weeks in the ipilimumab group and every 12 weeks in the triplet thera
167 CI 57-82) of patients in the nivolumab plus ipilimumab group and in 27% (16-40) of those in the nivo
168 l and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group versus the i
169 l and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared
170 patients were enrolled; two patients in the ipilimumab group and one patient in the nivolumab group
171 4 (62%) of 55 patients in the nivolumab plus ipilimumab group and seven (13%) of 56 in the nivolumab
172 l had not been reached in the nivolumab-plus-ipilimumab group and was 37.6 months in the nivolumab gr
173 sequentially into one of six cohorts: in the ipilimumab group fixed brentuximab vedotin 1.8 mg/kg wit
175 ratio for recurrence for the nivolumab plus ipilimumab group versus placebo group was 0.23 (97.5% CI
176 sly reported treatment-related deaths in the ipilimumab group were attributed to study drug toxicity
177 -related adverse events in the nivolumab and ipilimumab group were increased lipase (57 [10%] of 547)
178 olizumab 2 week group and 22 patients in the ipilimumab group withdrew consent and did not receive tr
179 D 19] in the placebo group vs 72 [22] in the ipilimumab group) and week 10 (77 [20] vs 70 [23]).
180 b group and 111 [25%] of 453 patients in the ipilimumab group) of 302 anticipated deaths observed (ab
181 rentuximab vedotin combined with ipilimumab (ipilimumab group), nivolumab (nivolumab group), or both
182 follow-up of 2.6 years (IQR 1.8-2.9) in the ipilimumab group, 2.4 years (2.2-2.6) in the nivolumab g
183 response rate was 57% (95% CI 34-78%) in the ipilimumab group, 61% (36-83%) in the nivolumab group, a
184 response rate was 76% (95% CI 53-92) in the ipilimumab group, 89% (65-99) in the nivolumab group, an
185 is 1.2 years (95% CI 1.7-not reached) in the ipilimumab group, but was not reached in the other two t
186 in 59% of the patients in the nivolumab-plus-ipilimumab group, in 21% of those in the nivolumab group
188 3-4 treatment related adverse events in the ipilimumab group, three (16%) in the nivolumab group, an
189 rvival was not reached in the nivolumab plus ipilimumab group, whereas median recurrence-free surviva
198 roups and in 50 (20%) of 256 patients in the ipilimumab group; the most common of these events were c
199 9 months in the nivolumab and nivolumab plus ipilimumab groups, respectively, with a PFI-stratified h
200 ETATION: In NSCLC, first-line nivolumab plus ipilimumab had a tolerable safety profile and showed enc
201 pembrolizumab group and was 16.0 months with ipilimumab (hazard ratio [HR] 0.68, 95% CI 0.53-0.87 for
203 phase 3, CheckMate 214 trial, nivolumab plus ipilimumab improved overall survival compared with sunit
204 nivolumab in combination with standard-dose ipilimumab improves objective response and progression-f
205 led to discontinuation of pembrolizumab and ipilimumab in 22 (14%) patients, including 17 (11%) who
207 elanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment bec
208 ed the efficacy and safety of nivolumab plus ipilimumab in combination, and nivolumab plus a tyrosine
209 umab alone, the combination of nivolumab and ipilimumab in EOC resulted in superior response rate and
210 ss the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment becaus
211 on-free survival and overall survival versus ipilimumab in patients with advanced melanoma and is now
212 how the long-term benefits of nivolumab plus ipilimumab in patients with previously untreated advance
213 his study was initiated, the clinical use of ipilimumab in refractory patients with unmet medical nee
215 ined recurrence-free survival benefit versus ipilimumab in resected stage IIIB-C or IV melanoma indic
217 Drug Administration approved the first ICI, ipilimumab, in 2011 for the treatment of metastatic mela
218 with nivolumab alone or in combination with ipilimumab increased recurrence-free survival significan
220 ll repertoire to a limited number of clones, ipilimumab induced greater diversification in the T-cell
221 atory inhibitory pathway in parallel with an ipilimumab-induced increase in tumor-infiltrating T cell
222 concurrent therapy with nivolumab (NIVO) and ipilimumab (IPI) in patients with previously treated or
223 icities of brentuximab vedotin combined with ipilimumab (ipilimumab group), nivolumab (nivolumab grou
227 lumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilo
228 of intravenous nivolumab every 2 weeks plus ipilimumab-matching placebo during weeks 1-12), or doubl
229 tandard-dose pembrolizumab plus reduced-dose ipilimumab might be a tolerable, efficacious treatment o
230 atients who received nivolumab combined with ipilimumab (n = 35, mucosal melanoma; n = 326, cutaneous
231 either nivolumab (n = 49), or nivolumab plus ipilimumab (n = 51), with PFI of < 6 months in 62%.
232 ly assigned to talimogene laherparepvec plus ipilimumab (n = 98), or ipilimumab alone (n = 100).
236 randomly assigned to receive nivolumab plus ipilimumab (n=56), nivolumab (n=59), or placebo (n=52).
237 Oncology Group performance status of 0 or 1, ipilimumab-naive histologically confirmed advanced melan
244 tage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received
245 fety and efficacy of adjuvant nivolumab plus ipilimumab or nivolumab monotherapy versus a placebo in
246 the average score reported during induction (ipilimumab or placebo at a dose of 10 mg/kg, administere
247 nts were randomly assigned to nivolumab plus ipilimumab or sunitinib (550 vs 546 in the intention-to-
248 with combination therapy with nivolumab plus ipilimumab or with nivolumab alone than with ipilimumab
251 ons of brentuximab vedotin with nivolumab or ipilimumab, or both in patients with relapsed or refract
252 that the superior efficacy of nivolumab plus ipilimumab over sunitinib comes with the additional bene
253 that the superior efficacy of nivolumab plus ipilimumab over sunitinib was maintained in intermediate
255 0.53-0.87 for pembrolizumab every 2 weeks vs ipilimumab; p=0.0009 and 0.68, 0.53-0.86 for pembrolizum
257 approval of nivolumab and the combination of ipilimumab plus nivolumab for the treatment of advanced
259 brolizumab (anti-PD-1), 5556 per 100 000 for ipilimumab plus nivolumab, and 3740 per 100 000 among al
260 In the unresectable/metastatic setting, ipilimumab plus nivolumab, nivolumab alone, or pembroliz
261 e ratio 1.38, 95% CI 1.08-1.77) or nivolumab/ipilimumab (rate ratio 1.30, 95% CI 1.02-1.65) were more
262 Compared with sunitinib, nivolumab plus ipilimumab reduced risk of deterioration in FKSI-19 tota
263 ponse compared with chemotherapy regimens in ipilimumab-refractory patients with advanced melanoma.
266 is study, nivolumab followed by two doses of ipilimumab resulted in no CRs and a low PR/CR conversion
267 lts from this trial show that treatment with ipilimumab results in longer recurrence-free survival co
269 n intention-to-treat patients, nivolumab and ipilimumab showed improved efficacy compared with suniti
270 phase 3 CheckMate 214 trial, nivolumab plus ipilimumab showed superior efficacy over sunitinib in pa
271 s who had received anti-CTLA4 immunotherapy (ipilimumab) showed upregulation of an IFNG-response gene
272 thout toxicity was longer for nivolumab plus ipilimumab than nivolumab (difference, 6.0 months) or ip
273 ROs were more favourable with nivolumab plus ipilimumab than sunitinib throughout the first 103 weeks
274 rts enrolling 190 MMel patients treated with ipilimumab, that PD-L1 expression on peripheral T cells
278 responsible for the selectivity exhibited by ipilimumab toward CTLA-4 relative to the homologous and
280 microenvironment, we evaluated untreated and ipilimumab-treated tumors from patients in a presurgical
281 een patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction
282 g T cells, we examined in this study whether ipilimumab treatment leads to clonal expansion of tissue
284 tients with metastatic melanoma treated with ipilimumab, tumor response according to PERCIST was asso
285 .00 (95% CI 1.91 to 6.09) for nivolumab plus ipilimumab versus -3.14 (-6.03 to -0.25) for sunitinib (
286 being 4.77 (1.73 to 7.82) for nivolumab plus ipilimumab versus -4.32 (-8.54 to -0.11) for sunitinib (
287 combination of talimogene laherparepvec plus ipilimumab versus ipilimumab alone in patients with adva
291 domly assigned (1:1) to receive nivolumab or ipilimumab via an interactive voice response system and
292 (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.52; hazard ratio for death
293 (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.55 [P<0.001]; hazard ratio
294 atients treated with nivolumab combined with ipilimumab was 5.9 months (95% CI, 2.8 months to not rea
296 otin and nivolumab were given every 3 weeks, ipilimumab was given every 6 weeks in the ipilimumab gro
299 EORTC 18071 phase 3 trial compared adjuvant ipilimumab with placebo in patients with stage III melan
300 to provide superior overall survival versus ipilimumab, with no difference between pembrolizumab dos