ClinicalTrials.gov

History of Changes for Study: NCT03199885
Paclitaxel, Trastuzumab, and Pertuzumab With or Without Pembrolizumab in Treating Patients With Metastatic Breast Cancer
Latest version (submitted August 5, 2022) on ClinicalTrials.gov
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  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 June 26, 2017 None (earliest Version on record)
2 June 30, 2017 Study Status
3 July 10, 2017 Study Status
4 August 14, 2017 Arms and Interventions and Study Status
5 September 4, 2017 Arms and Interventions and Study Status
6 October 16, 2017 Conditions and Study Status
7 December 11, 2017 Study Status
8 January 15, 2018 Arms and Interventions and Study Status
9 February 2, 2018 Study Status
10 February 15, 2018 Outcome Measures and Study Status
11 March 2, 2018 Study Status
12 June 11, 2018 Arms and Interventions and Study Status
13 July 9, 2018 Arms and Interventions, Outcome Measures, Study Design, Study Description, Study Identification, Eligibility, Conditions and Study Status
14 July 16, 2018 Study Status
15 August 1, 2018 Study Status
16 September 11, 2018 Contacts/Locations and Study Status
17 February 5, 2019 Contacts/Locations and Study Status
18 February 13, 2019 Study Status
19 April 3, 2019 Recruitment Status, Study Status, Arms and Interventions, Outcome Measures, Study Description, IPDSharing, Contacts/Locations, Eligibility, Conditions and Oversight
20 April 8, 2019 Contacts/Locations and Study Status
21 April 10, 2019 Contacts/Locations and Study Status
22 April 15, 2019 Contacts/Locations and Study Status
23 April 19, 2019 Contacts/Locations and Study Status
24 April 22, 2019 Contacts/Locations and Study Status
25 April 25, 2019 Contacts/Locations and Study Status
26 April 26, 2019 Contacts/Locations and Study Status
27 April 29, 2019 Contacts/Locations and Study Status
28 May 8, 2019 Contacts/Locations and Study Status
29 May 9, 2019 Contacts/Locations and Study Status
30 May 10, 2019 Contacts/Locations and Study Status
31 May 13, 2019 Contacts/Locations and Study Status
32 May 16, 2019 Contacts/Locations and Study Status
33 May 20, 2019 Contacts/Locations and Study Status
34 May 22, 2019 Contacts/Locations and Study Status
35 May 23, 2019 Contacts/Locations and Study Status
36 May 24, 2019 Contacts/Locations and Study Status
37 May 27, 2019 Contacts/Locations and Study Status
38 May 31, 2019 Contacts/Locations and Study Status
39 June 3, 2019 Contacts/Locations, Arms and Interventions and Study Status
40 June 5, 2019 Contacts/Locations and Study Status
41 June 6, 2019 Contacts/Locations and Study Status
42 June 10, 2019 Contacts/Locations and Study Status
43 June 12, 2019 Contacts/Locations and Study Status
44 June 13, 2019 Contacts/Locations and Study Status
45 June 17, 2019 Contacts/Locations and Study Status
46 June 20, 2019 Contacts/Locations and Study Status
47 June 24, 2019 Contacts/Locations and Study Status
48 June 26, 2019 Contacts/Locations and Study Status
49 June 27, 2019 Contacts/Locations and Study Status
50 July 1, 2019 Contacts/Locations and Study Status
51 July 2, 2019 Contacts/Locations and Study Status
52 July 3, 2019 Contacts/Locations and Study Status
53 July 8, 2019 Contacts/Locations and Study Status
54 July 10, 2019 Contacts/Locations and Study Status
55 July 11, 2019 Contacts/Locations and Study Status
56 July 15, 2019 Contacts/Locations and Study Status
57 July 16, 2019 Contacts/Locations and Study Status
58 July 17, 2019 Contacts/Locations, Sponsor/Collaborators and Study Status
59 July 18, 2019 Contacts/Locations and Study Status
60 July 19, 2019 Contacts/Locations and Study Status
61 July 22, 2019 Contacts/Locations and Study Status
62 July 23, 2019 Contacts/Locations and Study Status
63 July 25, 2019 Contacts/Locations and Study Status
64 July 26, 2019 Contacts/Locations and Study Status
65 July 29, 2019 Contacts/Locations and Study Status
66 July 30, 2019 Contacts/Locations and Study Status
67 July 31, 2019 Contacts/Locations and Study Status
68 August 1, 2019 Contacts/Locations and Study Status
69 August 5, 2019 Contacts/Locations and Study Status
70 August 6, 2019 Contacts/Locations and Study Status
71 August 7, 2019 Contacts/Locations and Study Status
72 August 8, 2019 Contacts/Locations and Study Status
73 August 9, 2019 Contacts/Locations and Study Status
74 August 12, 2019 Contacts/Locations, Arms and Interventions and Study Status
75 August 13, 2019 Contacts/Locations and Study Status
76 August 15, 2019 Contacts/Locations and Study Status
77 August 16, 2019 Contacts/Locations and Study Status
78 August 19, 2019 Contacts/Locations and Study Status
79 August 21, 2019 Contacts/Locations and Study Status
80 August 22, 2019 Contacts/Locations and Study Status
81 August 23, 2019 Contacts/Locations and Study Status
82 August 26, 2019 Contacts/Locations and Study Status
83 August 28, 2019 Contacts/Locations and Study Status
84 August 29, 2019 Contacts/Locations and Study Status
85 August 30, 2019 Contacts/Locations and Study Status
86 September 2, 2019 Contacts/Locations and Study Status
87 September 4, 2019 Contacts/Locations and Study Status
88 September 13, 2019 Contacts/Locations, Eligibility, Study Description, Oversight and Study Status
89 September 16, 2019 Contacts/Locations and Study Status
90 September 18, 2019 Contacts/Locations and Study Status
91 September 20, 2019 Contacts/Locations and Study Status
92 September 23, 2019 Study Status and Contacts/Locations
93 September 25, 2019 Contacts/Locations and Study Status
94 September 26, 2019 Contacts/Locations and Study Status
95 September 30, 2019 Contacts/Locations and Study Status
96 October 3, 2019 Contacts/Locations and Study Status
97 October 4, 2019 Contacts/Locations, Conditions and Study Status
98 October 7, 2019 Contacts/Locations and Study Status
99 October 9, 2019 Contacts/Locations and Study Status
100 October 10, 2019 Contacts/Locations and Study Status
101 October 11, 2019 Contacts/Locations and Study Status
102 October 14, 2019 Contacts/Locations and Study Status
103 October 16, 2019 Contacts/Locations and Study Status
104 October 17, 2019 Contacts/Locations and Study Status
105 October 21, 2019 Contacts/Locations and Study Status
106 October 23, 2019 Contacts/Locations and Study Status
107 October 24, 2019 Contacts/Locations and Study Status
108 October 25, 2019 Contacts/Locations and Study Status
109 October 28, 2019 Contacts/Locations and Study Status
110 October 30, 2019 Contacts/Locations and Study Status
111 October 31, 2019 Contacts/Locations and Study Status
112 November 1, 2019 Contacts/Locations and Study Status
113 November 4, 2019 Contacts/Locations and Study Status
114 November 5, 2019 Contacts/Locations and Study Status
115 November 6, 2019 Contacts/Locations and Study Status
116 November 7, 2019 Contacts/Locations and Study Status
117 November 8, 2019 Contacts/Locations and Study Status
118 November 11, 2019 Contacts/Locations and Study Status
119 November 15, 2019 Contacts/Locations and Study Status
120 November 18, 2019 Contacts/Locations and Study Status
121 November 20, 2019 Contacts/Locations and Study Status
122 November 22, 2019 Contacts/Locations and Study Status
123 November 25, 2019 Contacts/Locations and Study Status
124 November 29, 2019 Contacts/Locations and Study Status
125 December 4, 2019 Contacts/Locations and Study Status
126 December 6, 2019 Arms and Interventions and Study Status
127 December 9, 2019 Contacts/Locations and Study Status
128 December 12, 2019 Contacts/Locations and Study Status
129 December 13, 2019 Contacts/Locations and Study Status
130 December 20, 2019 Contacts/Locations and Study Status
131 December 23, 2019 Contacts/Locations and Study Status
132 December 24, 2019 Contacts/Locations and Study Status
133 December 26, 2019 Contacts/Locations and Study Status
134 January 1, 2020 Contacts/Locations and Study Status
135 January 6, 2020 Contacts/Locations and Study Status
136 January 8, 2020 Contacts/Locations and Study Status
137 January 13, 2020 Contacts/Locations and Study Status
138 January 15, 2020 Contacts/Locations and Study Status
139 January 16, 2020 Contacts/Locations and Study Status
140 January 17, 2020 Contacts/Locations and Study Status
141 January 20, 2020 Arms and Interventions and Study Status
142 January 22, 2020 Contacts/Locations and Study Status
143 January 23, 2020 Contacts/Locations and Study Status
144 January 24, 2020 Contacts/Locations and Study Status
145 January 27, 2020 Contacts/Locations and Study Status
146 January 28, 2020 Contacts/Locations and Study Status
147 January 29, 2020 Contacts/Locations and Study Status
148 January 31, 2020 Contacts/Locations and Study Status
149 February 3, 2020 Contacts/Locations, Arms and Interventions and Study Status
150 February 5, 2020 Contacts/Locations and Study Status
151 February 6, 2020 Contacts/Locations and Study Status
152 February 7, 2020 Contacts/Locations and Study Status
153 February 10, 2020 Contacts/Locations and Study Status
154 February 11, 2020 Study Status
155 February 13, 2020 Contacts/Locations and Study Status
156 February 14, 2020 Contacts/Locations and Study Status
157 February 17, 2020 Contacts/Locations and Study Status
158 February 19, 2020 Contacts/Locations and Study Status
159 February 20, 2020 Contacts/Locations and Study Status
160 February 21, 2020 Contacts/Locations and Study Status
161 February 24, 2020 Contacts/Locations and Study Status
162 February 25, 2020 Contacts/Locations and Study Status
163 February 26, 2020 Contacts/Locations and Study Status
164 February 27, 2020 Contacts/Locations and Study Status
165 February 28, 2020 Contacts/Locations and Study Status
166 March 2, 2020 Study Status
167 March 6, 2020 Contacts/Locations and Study Status
168 March 9, 2020 Contacts/Locations and Study Status
169 March 11, 2020 Contacts/Locations and Study Status
170 March 12, 2020 Contacts/Locations and Study Status
171 March 16, 2020 Contacts/Locations and Study Status
172 March 18, 2020 Contacts/Locations and Study Status
173 March 20, 2020 Contacts/Locations and Study Status
174 March 23, 2020 Contacts/Locations and Study Status
175 March 27, 2020 Contacts/Locations, Eligibility, Conditions, Study Description, Study Status and Study Identification
176 April 1, 2020 Contacts/Locations and Study Status
177 April 2, 2020 Contacts/Locations and Study Status
178 April 4, 2020 Study Status
179 April 9, 2020 Contacts/Locations and Study Status
180 April 14, 2020 Study Status
181 April 16, 2020 Contacts/Locations and Study Status
182 April 18, 2020 Contacts/Locations and Study Status
183 April 21, 2020 Contacts/Locations and Study Status
184 April 23, 2020 Contacts/Locations and Study Status
185 April 24, 2020 Contacts/Locations and Study Status
186 April 25, 2020 Contacts/Locations and Study Status
187 April 28, 2020 Contacts/Locations and Study Status
188 April 30, 2020 Contacts/Locations and Study Status
189 May 2, 2020 Contacts/Locations, Arms and Interventions and Study Status
190 May 5, 2020 Contacts/Locations and Study Status
191 May 6, 2020 Contacts/Locations and Study Status
192 May 7, 2020 Contacts/Locations and Study Status
193 May 8, 2020 Contacts/Locations and Study Status
194 May 9, 2020 Contacts/Locations and Study Status
195 May 13, 2020 Contacts/Locations and Study Status
196 May 16, 2020 Contacts/Locations and Study Status
197 May 19, 2020 Contacts/Locations and Study Status
198 May 21, 2020 Contacts/Locations and Study Status
199 May 26, 2020 Contacts/Locations and Study Status
200 May 27, 2020 Contacts/Locations and Study Status
201 May 28, 2020 Contacts/Locations and Study Status
202 May 29, 2020 Contacts/Locations and Study Status
203 May 30, 2020 Contacts/Locations and Study Status
204 June 2, 2020 Contacts/Locations and Study Status
205 June 3, 2020 Contacts/Locations and Study Status
206 June 4, 2020 Contacts/Locations and Study Status
207 June 6, 2020 Contacts/Locations and Study Status
208 June 9, 2020 Contacts/Locations and Study Status
209 June 13, 2020 Contacts/Locations and Study Status
210 June 16, 2020 Contacts/Locations and Study Status
211 June 18, 2020 Contacts/Locations and Study Status
212 June 19, 2020 Contacts/Locations and Study Status
213 June 20, 2020 Contacts/Locations and Study Status
214 June 23, 2020 Contacts/Locations and Study Status
215 June 24, 2020 Contacts/Locations and Study Status
216 June 25, 2020 Contacts/Locations and Study Status
217 June 26, 2020 Contacts/Locations and Study Status
218 June 30, 2020 Contacts/Locations and Study Status
219 July 1, 2020 Contacts/Locations and Study Status
220 July 3, 2020 Contacts/Locations and Study Status
221 July 7, 2020 Contacts/Locations and Study Status
222 July 8, 2020 Contacts/Locations and Study Status
223 July 9, 2020 Contacts/Locations and Study Status
224 July 10, 2020 Contacts/Locations and Study Status
225 July 15, 2020 Contacts/Locations and Study Status
226 July 16, 2020 Contacts/Locations and Study Status
227 July 17, 2020 Contacts/Locations and Study Status
228 July 18, 2020 Contacts/Locations and Study Status
229 July 22, 2020 Contacts/Locations and Study Status
230 July 23, 2020 Contacts/Locations and Study Status
231 July 25, 2020 Contacts/Locations and Study Status
232 July 29, 2020 Contacts/Locations and Study Status
233 July 30, 2020 Contacts/Locations and Study Status
234 July 31, 2020 Contacts/Locations and Study Status
235 August 4, 2020 Contacts/Locations and Study Status
236 August 8, 2020 Contacts/Locations and Study Status
237 August 11, 2020 Contacts/Locations and Study Status
238 August 13, 2020 Contacts/Locations and Study Status
239 August 15, 2020 Contacts/Locations and Study Status
240 August 19, 2020 Contacts/Locations and Study Status
241 August 21, 2020 Contacts/Locations and Study Status
242 August 25, 2020 Contacts/Locations and Study Status
243 August 27, 2020 Contacts/Locations and Study Status
244 August 28, 2020 Contacts/Locations and Study Status
245 August 29, 2020 Contacts/Locations and Study Status
246 September 1, 2020 Contacts/Locations and Study Status
247 September 2, 2020 Contacts/Locations and Study Status
248 September 3, 2020 Contacts/Locations and Study Status
249 September 4, 2020 Contacts/Locations and Study Status
250 September 8, 2020 Contacts/Locations and Study Status
251 September 9, 2020 Contacts/Locations and Study Status
252 September 11, 2020 Contacts/Locations and Study Status
253 September 12, 2020 Contacts/Locations and Study Status
254 September 15, 2020 Contacts/Locations and Study Status
255 September 16, 2020 Contacts/Locations and Study Status
256 September 17, 2020 Contacts/Locations and Study Status
257 September 18, 2020 Contacts/Locations and Study Status
258 September 19, 2020 Contacts/Locations and Study Status
259 September 26, 2020 Contacts/Locations and Study Status
260 September 29, 2020 Contacts/Locations and Study Status
261 September 30, 2020 Contacts/Locations and Study Status
262 October 2, 2020 Contacts/Locations and Study Status
263 October 6, 2020 Contacts/Locations and Study Status
264 October 7, 2020 Contacts/Locations and Study Status
265 October 8, 2020 Contacts/Locations and Study Status
266 October 9, 2020 Contacts/Locations and Study Status
267 October 10, 2020 Contacts/Locations and Study Status
268 October 13, 2020 Contacts/Locations and Study Status
269 October 14, 2020 Contacts/Locations and Study Status
270 October 15, 2020 Contacts/Locations and Study Status
271 October 16, 2020 Contacts/Locations and Study Status
272 October 17, 2020 Contacts/Locations and Study Status
273 October 20, 2020 Contacts/Locations, Arms and Interventions and Study Status
274 October 21, 2020 Contacts/Locations and Study Status
275 October 22, 2020 Contacts/Locations and Study Status
276 October 23, 2020 Contacts/Locations and Study Status
277 October 27, 2020 Contacts/Locations and Study Status
278 October 29, 2020 Study Status
279 November 4, 2020 Contacts/Locations and Study Status
280 November 6, 2020 Contacts/Locations and Study Status
281 November 7, 2020 Contacts/Locations and Study Status
282 November 10, 2020 Contacts/Locations and Study Status
283 November 12, 2020 Contacts/Locations and Study Status
284 November 13, 2020 Contacts/Locations and Study Status
285 November 14, 2020 Contacts/Locations and Study Status
286 November 17, 2020 Contacts/Locations and Study Status
287 November 18, 2020 Contacts/Locations and Study Status
288 November 19, 2020 Contacts/Locations and Study Status
289 November 20, 2020 Contacts/Locations and Study Status
290 November 21, 2020 Contacts/Locations and Study Status
291 November 24, 2020 Contacts/Locations and Study Status
292 November 27, 2020 Contacts/Locations and Study Status
293 December 1, 2020 Contacts/Locations and Study Status
294 December 12, 2020 Contacts/Locations and Study Status
295 December 19, 2020 Contacts/Locations and Study Status
296 December 22, 2020 Contacts/Locations and Study Status
297 December 23, 2020 Contacts/Locations and Study Status
298 December 29, 2020 Contacts/Locations and Study Status
299 December 30, 2020 Contacts/Locations and Study Status
300 December 31, 2020 Contacts/Locations and Study Status
301 January 1, 2021 Contacts/Locations and Study Status
302 January 5, 2021 Contacts/Locations and Study Status
303 January 6, 2021 Contacts/Locations and Study Status
304 January 7, 2021 Contacts/Locations and Study Status
305 January 8, 2021 Contacts/Locations and Study Status
306 January 9, 2021 Contacts/Locations and Study Status
307 January 12, 2021 Contacts/Locations and Study Status
308 January 13, 2021 Contacts/Locations and Study Status
309 January 14, 2021 Contacts/Locations and Study Status
310 January 15, 2021 Contacts/Locations and Study Status
311 January 19, 2021 Contacts/Locations and Study Status
312 January 20, 2021 Contacts/Locations and Study Status
313 January 22, 2021 Contacts/Locations and Study Status
314 January 23, 2021 Contacts/Locations and Study Status
315 January 26, 2021 Contacts/Locations and Study Status
316 January 30, 2021 Contacts/Locations and Study Status
317 February 2, 2021 Contacts/Locations and Study Status
318 February 3, 2021 Contacts/Locations and Study Status
319 February 4, 2021 Contacts/Locations and Study Status
320 February 6, 2021 Contacts/Locations and Study Status
321 February 9, 2021 Contacts/Locations and Study Status
322 February 10, 2021 Contacts/Locations and Study Status
323 February 11, 2021 Contacts/Locations and Study Status
324 February 12, 2021 Contacts/Locations and Study Status
325 February 16, 2021 Contacts/Locations, Arms and Interventions and Study Status
326 February 17, 2021 Contacts/Locations and Study Status
327 February 18, 2021 Contacts/Locations and Study Status
328 February 20, 2021 Contacts/Locations and Study Status
329 February 24, 2021 Contacts/Locations and Study Status
330 February 26, 2021 Contacts/Locations and Study Status
331 March 2, 2021 Contacts/Locations and Study Status
332 March 4, 2021 Contacts/Locations and Study Status
333 March 5, 2021 Contacts/Locations and Study Status
334 March 11, 2021 Contacts/Locations and Study Status
335 March 13, 2021 Contacts/Locations and Study Status
336 March 16, 2021 Contacts/Locations and Study Status
337 March 17, 2021 Contacts/Locations and Study Status
338 March 18, 2021 Contacts/Locations and Study Status
339 March 23, 2021 Contacts/Locations and Study Status
340 March 31, 2021 Contacts/Locations and Study Status
341 April 1, 2021 Contacts/Locations and Study Status
342 April 3, 2021 Contacts/Locations and Study Status
343 April 6, 2021 Contacts/Locations and Study Status
344 April 7, 2021 Contacts/Locations and Study Status
345 April 8, 2021 Contacts/Locations and Study Status
346 April 13, 2021 Contacts/Locations, Arms and Interventions and Study Status
347 April 14, 2021 Contacts/Locations and Study Status
348 April 15, 2021 Contacts/Locations and Study Status
349 April 17, 2021 Contacts/Locations and Study Status
350 April 21, 2021 Contacts/Locations and Study Status
351 April 23, 2021 Contacts/Locations and Study Status
352 April 27, 2021 Contacts/Locations and Study Status
353 April 28, 2021 Contacts/Locations and Study Status
354 April 30, 2021 Contacts/Locations and Study Status
355 May 1, 2021 Contacts/Locations and Study Status
356 May 4, 2021 Contacts/Locations and Study Status
357 May 5, 2021 Contacts/Locations and Study Status
358 May 7, 2021 Contacts/Locations and Study Status
359 May 12, 2021 Contacts/Locations and Study Status
360 May 14, 2021 Contacts/Locations and Study Status
361 May 15, 2021 Contacts/Locations and Study Status
362 May 18, 2021 Contacts/Locations and Study Status
363 May 19, 2021 Contacts/Locations and Study Status
364 May 20, 2021 Contacts/Locations and Study Status
365 May 21, 2021 Contacts/Locations and Study Status
366 May 22, 2021 Contacts/Locations and Study Status
367 May 25, 2021 Contacts/Locations and Study Status
368 May 27, 2021 Contacts/Locations and Study Status
369 June 1, 2021 Contacts/Locations and Study Status
370 June 4, 2021 Contacts/Locations and Study Status
371 June 5, 2021 Contacts/Locations and Study Status
372 June 8, 2021 Contacts/Locations and Study Status
373 June 10, 2021 Contacts/Locations and Study Status
374 June 12, 2021 Contacts/Locations and Study Status
375 June 16, 2021 Contacts/Locations and Study Status
376 June 18, 2021 Contacts/Locations and Study Status
377 July 2, 2021 Recruitment Status, Arms and Interventions, Study Status, Contacts/Locations, Study Description, Eligibility, Outcome Measures and Study Identification
378 July 10, 2021 Study Status
379 August 11, 2021 Recruitment Status, Study Status and Contacts/Locations
380 August 17, 2021 Contacts/Locations and Study Status
381 August 18, 2021 Contacts/Locations and Study Status
382 August 19, 2021 Contacts/Locations and Study Status
383 August 21, 2021 Contacts/Locations and Study Status
384 August 24, 2021 Contacts/Locations and Study Status
385 August 25, 2021 Contacts/Locations and Study Status
386 August 26, 2021 Contacts/Locations and Study Status
387 August 27, 2021 Study Status
388 August 31, 2021 Contacts/Locations and Study Status
389 September 2, 2021 Contacts/Locations and Study Status
390 September 3, 2021 Contacts/Locations and Study Status
391 September 7, 2021 Contacts/Locations and Study Status
392 September 9, 2021 Contacts/Locations and Study Status
393 September 10, 2021 Contacts/Locations and Study Status
394 September 14, 2021 Contacts/Locations and Study Status
395 September 16, 2021 Contacts/Locations and Study Status
396 September 18, 2021 Contacts/Locations and Study Status
397 September 21, 2021 Contacts/Locations and Study Status
398 September 22, 2021 Contacts/Locations and Study Status
399 September 24, 2021 Contacts/Locations and Study Status
400 September 25, 2021 Contacts/Locations and Study Status
401 September 28, 2021 Contacts/Locations and Study Status
402 September 30, 2021 Contacts/Locations and Study Status
403 October 1, 2021 Contacts/Locations and Study Status
404 October 2, 2021 Contacts/Locations and Study Status
405 October 5, 2021 Contacts/Locations and Study Status
406 October 6, 2021 Contacts/Locations and Study Status
407 October 7, 2021 Contacts/Locations and Study Status
408 October 8, 2021 Contacts/Locations and Study Status
409 October 9, 2021 Contacts/Locations and Study Status
410 October 12, 2021 Contacts/Locations and Study Status
411 October 13, 2021 Contacts/Locations and Study Status
412 October 14, 2021 Contacts/Locations and Study Status
413 October 16, 2021 Contacts/Locations and Study Status
414 October 19, 2021 Contacts/Locations and Study Status
415 October 20, 2021 Contacts/Locations and Study Status
416 October 22, 2021 Contacts/Locations and Study Status
417 October 26, 2021 Contacts/Locations and Study Status
418 October 28, 2021 Contacts/Locations and Study Status
419 November 2, 2021 Contacts/Locations and Study Status
420 November 3, 2021 Contacts/Locations and Study Status
421 November 5, 2021 Contacts/Locations and Study Status
422 November 9, 2021 Contacts/Locations and Study Status
423 November 10, 2021 Contacts/Locations and Study Status
424 November 12, 2021 Contacts/Locations and Study Status
425 November 13, 2021 Contacts/Locations and Study Status
426 November 16, 2021 Contacts/Locations and Study Status
427 November 17, 2021 Contacts/Locations and Study Status
428 November 18, 2021 Contacts/Locations and Study Status
429 November 19, 2021 Contacts/Locations and Study Status
430 November 20, 2021 Contacts/Locations and Study Status
431 November 25, 2021 Contacts/Locations and Study Status
432 December 1, 2021 Contacts/Locations and Study Status
433 December 3, 2021 Contacts/Locations and Study Status
434 December 7, 2021 Contacts/Locations and Study Status
435 December 8, 2021 Contacts/Locations and Study Status
436 December 11, 2021 Contacts/Locations and Study Status
437 December 14, 2021 Contacts/Locations and Study Status
438 December 16, 2021 Contacts/Locations and Study Status
439 December 17, 2021 Contacts/Locations and Study Status
440 December 22, 2021 Contacts/Locations and Study Status
441 December 23, 2021 Contacts/Locations and Study Status
442 January 4, 2022 Contacts/Locations and Study Status
443 January 5, 2022 Contacts/Locations and Study Status
444 January 6, 2022 Contacts/Locations and Study Status
445 January 8, 2022 Contacts/Locations and Study Status
446 January 11, 2022 Contacts/Locations and Study Status
447 January 14, 2022 Contacts/Locations and Study Status
448 January 18, 2022 Contacts/Locations and Study Status
449 January 20, 2022 Contacts/Locations and Study Status
450 January 21, 2022 Contacts/Locations and Study Status
451 January 22, 2022 Contacts/Locations and Study Status
452 January 26, 2022 Contacts/Locations and Study Status
453 January 28, 2022 Contacts/Locations and Study Status
454 February 1, 2022 Contacts/Locations and Study Status
455 February 2, 2022 Contacts/Locations and Study Status
456 February 17, 2022 Contacts/Locations, Eligibility, Oversight and Study Status
457 February 18, 2022 Contacts/Locations and Study Status
458 February 19, 2022 Contacts/Locations and Study Status
459 February 22, 2022 Contacts/Locations and Study Status
460 February 23, 2022 Contacts/Locations and Study Status
461 February 25, 2022 Contacts/Locations and Study Status
462 February 26, 2022 Contacts/Locations and Study Status
463 March 2, 2022 Contacts/Locations and Study Status
464 March 3, 2022 Contacts/Locations and Study Status
465 March 5, 2022 Contacts/Locations and Study Status
466 March 8, 2022 Contacts/Locations and Study Status
467 March 9, 2022 Contacts/Locations and Study Status
468 March 11, 2022 Contacts/Locations and Study Status
469 March 16, 2022 Contacts/Locations and Study Status
470 March 17, 2022 Contacts/Locations and Study Status
471 March 19, 2022 Contacts/Locations and Study Status
472 March 22, 2022 Contacts/Locations and Study Status
473 March 25, 2022 Contacts/Locations and Study Status
474 March 30, 2022 Contacts/Locations and Study Status
475 March 31, 2022 Contacts/Locations, Arms and Interventions, Study Description and Study Status
476 April 2, 2022 Contacts/Locations and Study Status
477 April 6, 2022 Contacts/Locations and Study Status
478 April 12, 2022 Contacts/Locations and Study Status
479 April 13, 2022 Contacts/Locations and Study Status
480 April 14, 2022 Contacts/Locations and Study Status
481 April 15, 2022 Contacts/Locations and Study Status
482 April 16, 2022 Contacts/Locations and Study Status
483 April 20, 2022 Contacts/Locations and Study Status
484 April 26, 2022 Contacts/Locations and Study Status
485 April 27, 2022 Contacts/Locations and Study Status
486 April 28, 2022 Contacts/Locations and Study Status
487 April 29, 2022 Contacts/Locations and Study Status
488 April 30, 2022 Recruitment Status, Study Status and Contacts/Locations
489 May 3, 2022 Study Status
490 May 4, 2022 Study Description and Study Status
491 May 5, 2022 Study Description and Study Status
492 May 18, 2022 Study Status
493 May 21, 2022 Recruitment Status and Study Status
494 May 24, 2022 Study Status
495 June 7, 2022 Arms and Interventions and Study Status
496 June 9, 2022 Contacts/Locations and Study Status
497 June 10, 2022 Contacts/Locations and Study Status
498 June 28, 2022 Arms and Interventions and Study Status
499 July 22, 2022 Contacts/Locations and Study Status
500 August 5, 2022 Contacts/Locations and Study Status
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Study NCT03199885
Submitted Date:  June 26, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: NCI-2017-01119
Brief Title: Paclitaxel, Trastuzumab, and Pertuzumab With or Without Pembrolizumab in Treating Patients With Metastatic Breast Cancer
Official Title: A Randomized Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab Compared to Paclitaxel/Trastuzumab/Pertuzumab/Pembrolizumab in First-Line HER2-Positive Metastatic Breast Cancer
Secondary IDs: NCI-2017-01119 [Registry Identifier: CTRP (Clinical Trial Reporting Program)]
NRG-BR004 [NRG Oncology]
NRG-BR004 [CTEP]
U10CA180868 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: June 2017
Overall Status: Not yet recruiting
Study Start: July 11, 2018
Primary Completion: December 31, 2020 [Anticipated]
Study Completion: December 31, 2020 [Anticipated]
First Submitted: June 26, 2017
First Submitted that
Met QC Criteria:
June 26, 2017
First Posted: June 27, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
June 26, 2017
Last Update Posted: June 27, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: National Cancer Institute (NCI)
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without pembrolizumab works in treating patients with breast cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, pertuzumab, and pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Giving paclitaxel, trastuzumab, and pertuzumab with pembrolizumab may kill more tumor cells.
Detailed Description:

PRIMARY OBJECTIVES:

I. To determine whether the addition of pembrolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the progression-free survival (PFS), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, and trastuzumab in patients with newly documented HER2-positive metastatic breast cancer.

SECONDARY OBJECTIVES:

I. To determine whether the addition of pembrolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the overall survival (OS) relative to a regimen of paclitaxel, pertuzumab, and trastuzumab.

II. To determine whether the addition of pembrolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the overall objective response, as assessed by RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, and trastuzumab.

III. To determine whether the addition of pembrolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the duration of objective response, as assessed by RECIST 1.1 criteria, relative to a regimen of paclitaxel, pertuzumab, and trastuzumab.

IV. To determine whether the addition of pembrolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will decrease the incidence of subsequent brain metastases in patients without known brain metastases at study entry relative to a regimen of paclitaxel, pertuzumab, and trastuzumab.

V. To determine whether the addition of pembrolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will contribute to increased patient-reported fatigue in comparison to a regimen of paclitaxel, pertuzumab, and trastuzumab.

VI. To determine whether the addition of pembrolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will contribute to poorer patient-reported physical function in comparison to a regimen of paclitaxel, pertuzumab, and trastuzumab.

VII. To determine the toxicity profile of the two treatment regimens using patient-reported symptom assessments in addition to standard adverse event reports.

VIII. To determine the immune-related toxicity profile of the two treatment regimens.

IX. To determine the cardiac safety profile of the two treatment regimens. X. To identify potential biomarkers that can predict benefit from the addition of pembrolizumab in patients with newly documented HER2-positive metastatic breast cancer treated with a regimen of paclitaxel, pertuzumab, and trastuzumab.

TERTIARY OBJECTIVES:

I. To determine whether the addition of pembrolizumab to a regimen of paclitaxel, pertuzumab, and trastuzumab will improve the progression-free survival and overall objective response, as assessed by immune-related response criteria immune-related response criteria (irRECIST), relative to a regimen of paclitaxel, pertuzumab, and trastuzumab.

II. To determine the feasibility and added value of frequent assessment of toxicity using patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) with electronic patient-reported outcomes (ePRO) reporting.

OUTLINE: Patients are randomized to 1 of 2 groups.

ARM I: Patients receive pertuzumab intravenously (IV) over 30-60 minutes on day 1 and trastuzumab IV over 30-90 minutes on day 1. Patients also receive paclitaxel IV over 60 minutes on days 1 and 8. Treatment with paclitaxel repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive pertuzumab, trastuzumab, and paclitaxel as in Arm I. Patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years and then every six months for 2 years.

Open or close this module Conditions
Conditions: HER2/Neu Positive
Recurrent Breast Carcinoma
Stage IV Breast Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 480 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Arm I (pertuzumab, trastuzumab, paclitaxel)
Patients receive pertuzumab IV over 30-60 minutes on day 1 and trastuzumab IV over 30-90 minutes on day 1. Patients also receive paclitaxel IV over 60 minutes on days 1 and 8. Treatment with paclitaxel repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
Biological: Pertuzumab
Given IV
Other Names:
  • 2C4
  • 2C4 Antibody
  • MoAb 2C4
  • Monoclonal Antibody 2C4
  • Perjeta
  • rhuMAb2C4
  • RO4368451
Biological: Trastuzumab
Given IV
Other Names:
  • ABP 980
  • Anti-c-ERB-2
  • Anti-c-erbB2 Monoclonal Antibody
  • Anti-ERB-2
  • Anti-erbB-2
  • Anti-erbB2 Monoclonal Antibody
  • Anti-HER2/c-erbB2 Monoclonal Antibody
  • Anti-p185-HER2
  • c-erb-2 Monoclonal Antibody
  • HER2 Monoclonal Antibody
  • Herceptin
  • Herceptin Biosimilar PF-05280014
  • Herceptin Trastuzumab Biosimilar PF-05280014
  • MoAb HER2
  • Monoclonal Antibody c-erb-2
  • Monoclonal Antibody HER2
  • PF-05280014
  • rhuMAb HER2
  • RO0452317
  • Trastuzumab Biosimilar ABP 980
  • Trastuzumab Biosimilar PF-05280014
Experimental: Arm II (pertuzumab, trastuzumab, paclitaxel, pembrolizumab)
Patients receive pertuzumab, trastuzumab, and paclitaxel as in Arm I. Patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis
Correlative studies
Drug: Paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • Bristaxol
  • Praxel
  • Taxol
  • Taxol Konzentrat
Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475
Biological: Trastuzumab
Given IV
Other Names:
  • ABP 980
  • Anti-c-ERB-2
  • Anti-c-erbB2 Monoclonal Antibody
  • Anti-ERB-2
  • Anti-erbB-2
  • Anti-erbB2 Monoclonal Antibody
  • Anti-HER2/c-erbB2 Monoclonal Antibody
  • Anti-p185-HER2
  • c-erb-2 Monoclonal Antibody
  • HER2 Monoclonal Antibody
  • Herceptin
  • Herceptin Biosimilar PF-05280014
  • Herceptin Trastuzumab Biosimilar PF-05280014
  • MoAb HER2
  • Monoclonal Antibody c-erb-2
  • Monoclonal Antibody HER2
  • PF-05280014
  • rhuMAb HER2
  • RO0452317
  • Trastuzumab Biosimilar ABP 980
  • Trastuzumab Biosimilar PF-05280014
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression free survival
[ Time Frame: The time from randomization to the first documented progressive disease assessed up to 5 years ]

Will be determined using the current Response Evaluation Criteria in Solid Tumors 1.1 criteria. Analysis will be based on the intent to treat population. The stratified log-rank test will be used to compare the progression free survival between the two treatment arms with the following stratification factors: prior neoadjuvant or adjuvant therapy with trastuzumab (no prior trastuzumab; prior trastuzumab and no pertuzumab; prior trastuzumab and pertuzumab), estrogen receptor status (positive; negative), and disease sites (any visceral without brain metastasis; non-visceral only without brain me
Secondary Outcome Measures:
1. Cumulative incidence of brain metastases
[ Time Frame: The time from randomization to documentation of brain metastases, assessed up to 5 years ]

Analysis will be based on the intent to treat population. The Kaplan-Meier estimates will be calculated by treatment arms. Stratified Cox proportional hazards models to estimate the hazard ratio.
2. Duration of response
[ Time Frame: From the date of initial confirmed partial response or complete response until the date of progressive disease or death from any cause assessed up to 5 years ]

Tumor responses will be based on the current Response Evaluation Criteria in Solid Tumors 1.1 criteria.
3. Frequency of adverse events, including late immune-related toxicities
[ Time Frame: Up to 5 years ]

Will be categorized using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0.
4. Objective response, defined as complete response or partial response
[ Time Frame: Up to 5 years ]

Will be determined using Response Evaluation Criteria in Solid Tumors 1.1 criteria.
5. Overall survival
[ Time Frame: The time from randomization to death from any cause, assessed up to 5 years ]

Analysis will be based on the intent to treat population. The Kaplan-Meier estimates will be calculated by treatment arms. Stratified Cox proportional hazards models to estimate the hazard ratio.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease confirmed as described below; eligible patients include those with either:
    • De novo metastatic disease presenting without prior history of HER2-positive breast cancer:
      • Diagnosis should be made from the biopsy of a metastatic disease site (preferred), but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites is thought to carry excessive risk for the patient
    • Locally recurrent or metastatic disease following prior therapy for early breast cancer:
      • Diagnosis must be made from the biopsy of the locally recurrent or metastatic disease
      • There must be an interval of >= 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy
  • Patients with measurable and non-measurable disease are eligible
  • The tumor specimen obtained at the time of diagnosis at the time of locally recurrent or metastatic disease must have been determined to be HER2-positive based on standard methods used to determine HER2 status of locally recurrent or metastatic disease; HER2-positive is defined as HER2/chromosome enumeration probe 17 (CEP17) ratio >= 2.0 or >= 6 average HER2 copy number per cell by fluorescence in situ hybridization (FISH) or immunohistochemistry (IHC) 3+ by current American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
  • The tumor specimen obtained at the time of diagnosis used for HER2 testing must also have estrogen receptor (ER) analysis performed on it according to current ASCO/CAP Guideline Recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP Guideline Recommendations for hormone receptor testing; patients with < 1% ER and PgR staining by IHC will be classified as negative
  • Patients may have received one endocrine therapy regimen for locally recurrent or metastatic breast cancer with or without co-administration of trastuzumab before randomization
  • Localized palliative radiation therapy is allowed for symptom management if completed >= 2 weeks prior to randomization
  • Patients must have imaging of the chest/abdomen/pelvis, preferably with a computed tomography (CT) scan, and a bone scan within 4 weeks prior to randomization; (NOTE: if a patient is unable to receive CT contrast, a magnetic resonance imaging [MRI] of the abdomen/pelvis and non-contrast chest CT should be performed; positron emission tomography/computed tomography [PET/CT] is not an acceptable alternative)
  • MRI of the brain (or contrast CT scan of the brain if patients are unable to undergo MRI) must be obtained in patients with symptoms suggesting possible central nervous system (CNS) metastatic disease; neuroimaging is recommended but not required in asymptomatic patients
  • Patients with brain metastases documented concurrently with initial non-CNS metastases will be eligible after completing therapy for their brain metastases and are tolerating steroid tapering; patients who received treatment with trastuzumab or lapatinib concurrently with radiation therapy for brain metastases are eligible
  • Absolute neutrophil count (ANC) must be >= 1200/mm^3
  • Platelet count must be >= 100,000/mm^3
  • Hemoglobin must be >= 9 g/dL (without packed red blood cell transfusion within 4 weeks prior to randomization or not erythropoietin dependent)
  • Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULN
  • Aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) must be =< 2.5 x ULN for the lab or =< 5 x ULN for patients with liver metastases.
  • Serum creatinine =< 1.5 x ULN or measured or calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab
  • A serum thyroid-stimulating hormone (TSH) must be obtained within 10 days prior to randomization to obtain a baseline value
  • Left ventricular ejection fraction (LVEF) assessment must be performed within 6 weeks prior to randomization; (LVEF assessment performed by echocardiogram is preferred; however, multigated acquisition scan (MUGA) scan may be substituted based on institutional preferences); the LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal

Exclusion Criteria:

  • Central nervous system metastases that are untreated or require chronic corticosteroid therapy
  • Leptomeningeal carcinomatosis
  • Patients with metastatic disease limited to the CNS
  • History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for MBC with exceptions of:
    • One prior hormonal regimen for metastatic breast cancer (MBC) with or without co-administration of trastuzumab; and/or
    • Administration of trastuzumab or lapatinib concurrently with radiation therapy for brain metastases
  • History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent
  • Prior or current treatment with PD-1 or PD-L1 inhibitors or other immune-based therapy
  • Prior treatment with CDK 4/6 inhibitors for treatment of metastatic disease
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to randomization or who has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
  • Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
  • History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
  • Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:
    • Active cardiac disease
      • Angina pectoris that requires the current use of anti-anginal medication;
      • Ventricular arrhythmias except for benign premature ventricular contractions;
      • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;
      • Conduction abnormality requiring a pacemaker;
      • Valvular disease with documented compromise in cardiac function; or
      • Symptomatic pericarditis
    • History of cardiac disease
      • Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;
      • History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%; or
      • Documented cardiomyopathy
  • Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0
  • Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin) within 4 weeks prior to randomization
  • Active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to randomization; NOTE: intranasal and inhaled corticosteroids or systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or an equivalent corticosteroid are allowed
  • Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus (HCV) ribonucleic acid [RNA] [qualitative] is detected)
  • Has a known history of active TB (Bacillus tuberculosis)
  • Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 4 weeks prior to randomization:
    • Stable and adequate CD4 counts (>= 350/mm^3); and
    • Serum HIV viral load of < 25,000 IU/mL; and
    • Must be on a stable anti-retroviral regimen
  • Has an active infection requiring systemic therapy
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis or history of interstitial lung disease
  • Has received a live-virus vaccination within 28 days of randomization; seasonal flu vaccines that do not contain live virus are permitted
  • Known hypersensitivity to any of the study drugs or excipients, (e.g., Cremophor EL)
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results
  • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 7 months after the last dose of study treatment; (NOTE: pregnancy testing according to institutional standards for women of childbearing potential must be performed within 72 hours prior to randomization)
  • Use of any investigational product within 4 weeks prior to randomization
Open or close this module Contacts/Locations
Study Officials: Charles Geyer
Principal Investigator
NRG Oncology
Locations: United States, Pennsylvania
NRG Oncology
Philadelphia, Pennsylvania, United States, 19103
Contact:Contact: Charles E. Geyer 804-628-1939
Contact:Principal Investigator: Charles E. Geyer
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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