ClinicalTrials.gov

History of Changes for Study: NCT02834013
Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Latest version (submitted August 16, 2022) on ClinicalTrials.gov
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  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 July 13, 2016 None (earliest Version on record)
2 July 26, 2016 Recruitment Status, Study Status and Contacts/Locations
3 July 27, 2016 Study Status
4 August 23, 2016 Contacts/Locations and Study Status
5 August 24, 2016 Contacts/Locations and Study Status
6 December 16, 2016 Study Design and Study Status
7 December 30, 2016 Study Status
8 January 2, 2017 Study Status
9 January 6, 2017 Study Status
10 January 12, 2017 Eligibility, Study Status and Study Identification
11 January 18, 2017 Recruitment Status, Study Status and Contacts/Locations
12 January 19, 2017 Study Status
13 January 20, 2017 Study Status
14 January 23, 2017 Study Status
15 January 24, 2017 Oversight and Study Status
16 January 31, 2017 Study Status
17 February 9, 2017 Study Status, Contacts/Locations, Eligibility and Oversight
18 February 10, 2017 Contacts/Locations and Study Status
19 February 14, 2017 Contacts/Locations and Study Status
20 February 15, 2017 Contacts/Locations and Study Status
21 February 16, 2017 Contacts/Locations and Study Status
22 February 22, 2017 Contacts/Locations and Study Status
23 February 23, 2017 Contacts/Locations and Study Status
24 February 27, 2017 Contacts/Locations and Study Status
25 March 2, 2017 Contacts/Locations and Study Status
26 March 3, 2017 Contacts/Locations and Study Status
27 March 6, 2017 Contacts/Locations and Study Status
28 March 13, 2017 Contacts/Locations and Study Status
29 March 17, 2017 Conditions and Study Status
30 March 20, 2017 Contacts/Locations and Study Status
31 March 22, 2017 Contacts/Locations and Study Status
32 March 23, 2017 Contacts/Locations and Study Status
33 March 27, 2017 Contacts/Locations, Conditions and Study Status
34 March 30, 2017 Contacts/Locations and Study Status
35 March 31, 2017 Contacts/Locations and Study Status
36 April 3, 2017 Contacts/Locations and Study Status
37 April 4, 2017 Contacts/Locations and Study Status
38 April 6, 2017 Contacts/Locations and Study Status
39 April 7, 2017 Contacts/Locations and Study Status
40 April 10, 2017 Contacts/Locations and Study Status
41 April 12, 2017 Contacts/Locations and Study Status
42 April 13, 2017 Study Status
43 April 14, 2017 Study Status
44 April 18, 2017 Study Status
45 April 19, 2017 Contacts/Locations and Study Status
46 April 20, 2017 Study Status
47 April 24, 2017 Study Status
48 April 25, 2017 Study Status
49 April 26, 2017 Contacts/Locations and Study Status
50 April 27, 2017 Conditions and Study Status
51 April 28, 2017 Contacts/Locations and Study Status
52 May 1, 2017 Contacts/Locations and Study Status
53 May 2, 2017 Study Status
54 May 3, 2017 Contacts/Locations and Study Status
55 May 4, 2017 Contacts/Locations and Study Status
56 May 5, 2017 Contacts/Locations and Study Status
57 May 8, 2017 Contacts/Locations and Study Status
58 May 10, 2017 Contacts/Locations and Study Status
59 May 11, 2017 Contacts/Locations and Study Status
60 May 12, 2017 Conditions and Study Status
61 May 15, 2017 Contacts/Locations and Study Status
62 May 16, 2017 Study Status
63 May 17, 2017 Study Status
64 May 18, 2017 Contacts/Locations and Study Status
65 May 19, 2017 Contacts/Locations and Study Status
66 May 23, 2017 Study Status and Contacts/Locations
67 May 24, 2017 Contacts/Locations and Study Status
68 May 26, 2017 Contacts/Locations and Study Status
69 May 29, 2017 Contacts/Locations and Study Status
70 May 31, 2017 Study Status
71 June 1, 2017 Study Status
72 June 2, 2017 Contacts/Locations and Study Status
73 June 5, 2017 Contacts/Locations and Study Status
74 June 6, 2017 Study Status
75 June 7, 2017 Contacts/Locations and Study Status
76 June 8, 2017 Contacts/Locations and Study Status
77 June 9, 2017 Study Status
78 June 12, 2017 Contacts/Locations and Study Status
79 June 13, 2017 Study Status
80 June 14, 2017 Contacts/Locations and Study Status
81 June 15, 2017 Contacts/Locations and Study Status
82 June 16, 2017 Contacts/Locations and Study Status
83 June 19, 2017 Contacts/Locations and Study Status
84 June 20, 2017 Study Status
85 June 21, 2017 Study Status
86 June 22, 2017 Contacts/Locations and Study Status
87 June 23, 2017 Contacts/Locations and Study Status
88 June 26, 2017 Contacts/Locations and Study Status
89 June 27, 2017 Contacts/Locations and Study Status
90 June 28, 2017 Contacts/Locations and Study Status
91 June 29, 2017 Contacts/Locations and Study Status
92 June 30, 2017 Contacts/Locations and Study Status
93 July 3, 2017 Contacts/Locations and Study Status
94 July 5, 2017 Study Status
95 July 6, 2017 Study Status
96 July 7, 2017 Study Status
97 July 10, 2017 Contacts/Locations, Conditions and Study Status
98 July 11, 2017 Study Status
99 July 12, 2017 Contacts/Locations and Study Status
100 July 13, 2017 Contacts/Locations and Study Status
101 July 14, 2017 Contacts/Locations and Study Status
102 July 17, 2017 Study Status
103 July 18, 2017 Study Status
104 July 19, 2017 Study Status
105 July 20, 2017 Study Status
106 July 21, 2017 Study Status
107 July 24, 2017 Contacts/Locations and Study Status
108 July 25, 2017 Study Status
109 July 26, 2017 Study Status
110 July 27, 2017 Contacts/Locations and Study Status
111 July 28, 2017 Contacts/Locations and Study Status
112 July 31, 2017 Study Status
113 August 1, 2017 Contacts/Locations and Study Status
114 August 2, 2017 Contacts/Locations and Study Status
115 August 3, 2017 Study Status
116 August 4, 2017 Contacts/Locations and Study Status
117 August 7, 2017 Study Status
118 August 8, 2017 Contacts/Locations and Study Status
119 August 9, 2017 Study Status
120 August 10, 2017 Contacts/Locations and Study Status
121 August 11, 2017 Contacts/Locations and Study Status
122 August 14, 2017 Contacts/Locations, Arms and Interventions and Study Status
123 August 25, 2017 Contacts/Locations, Outcome Measures, Eligibility and Study Status
124 August 28, 2017 Contacts/Locations and Study Status
125 August 29, 2017 Study Status
126 August 30, 2017 Contacts/Locations and Study Status
127 August 31, 2017 Study Status
128 September 1, 2017 Study Status
129 September 5, 2017 Study Status, Contacts/Locations and Arms and Interventions
130 September 6, 2017 Study Status
131 September 7, 2017 Study Status
132 September 8, 2017 Contacts/Locations and Study Status
133 September 11, 2017 Contacts/Locations and Study Status
134 September 12, 2017 Study Status
135 September 13, 2017 Contacts/Locations and Study Status
136 September 14, 2017 Study Status
137 September 15, 2017 Contacts/Locations and Study Status
138 September 18, 2017 Contacts/Locations and Study Status
139 September 19, 2017 Study Status
140 September 20, 2017 Study Status
141 September 21, 2017 Study Status
142 September 22, 2017 Study Status
143 September 25, 2017 Contacts/Locations and Study Status
144 September 26, 2017 Study Status
145 September 27, 2017 Study Status
146 September 28, 2017 Contacts/Locations and Study Status
147 September 29, 2017 Contacts/Locations and Study Status
148 October 2, 2017 Contacts/Locations and Study Status
149 October 3, 2017 Study Status
150 October 4, 2017 Contacts/Locations and Study Status
151 October 5, 2017 Study Status
152 October 6, 2017 Contacts/Locations and Study Status
153 October 9, 2017 Contacts/Locations and Study Status
154 October 10, 2017 Study Status
155 October 11, 2017 Study Status
156 October 12, 2017 Study Status
157 October 13, 2017 Study Status
158 October 16, 2017 Contacts/Locations and Study Status
159 October 17, 2017 Study Status
160 October 18, 2017 Contacts/Locations and Study Status
161 October 19, 2017 Study Status
162 October 20, 2017 Study Status
163 October 23, 2017 Study Status
164 October 24, 2017 Study Status
165 October 25, 2017 Contacts/Locations and Study Status
166 October 26, 2017 Contacts/Locations and Study Status
167 October 27, 2017 Contacts/Locations and Study Status
168 October 30, 2017 Study Status
169 October 31, 2017 Study Status
170 November 1, 2017 Contacts/Locations and Study Status
171 November 2, 2017 Contacts/Locations and Study Status
172 November 16, 2017 Contacts/Locations, Study Status, Eligibility, Study Design and Study Description
173 November 17, 2017 Contacts/Locations and Study Status
174 November 20, 2017 Contacts/Locations and Study Status
175 November 21, 2017 Study Status
176 November 22, 2017 Study Status
177 November 24, 2017 Contacts/Locations and Study Status
178 November 27, 2017 Study Status
179 November 28, 2017 Contacts/Locations and Study Status
180 November 29, 2017 Study Status
181 November 30, 2017 Contacts/Locations and Study Status
182 December 1, 2017 Contacts/Locations and Study Status
183 December 4, 2017 Contacts/Locations and Study Status
184 December 5, 2017 Study Status
185 December 6, 2017 Study Status
186 December 7, 2017 Study Status
187 December 8, 2017 Contacts/Locations and Study Status
188 December 11, 2017 Contacts/Locations and Study Status
189 December 12, 2017 Study Status
190 December 13, 2017 Study Status
191 December 14, 2017 Study Status
192 December 15, 2017 Contacts/Locations and Study Status
193 December 18, 2017 Contacts/Locations and Study Status
194 December 19, 2017 Study Status
195 December 20, 2017 Contacts/Locations and Study Status
196 December 21, 2017 Contacts/Locations and Study Status
197 December 22, 2017 Contacts/Locations and Study Status
198 December 26, 2017 Study Status
199 December 27, 2017 Study Status
200 December 28, 2017 Contacts/Locations and Study Status
201 December 29, 2017 Study Status
202 January 2, 2018 Contacts/Locations and Study Status
203 January 3, 2018 Contacts/Locations and Study Status
204 January 4, 2018 Study Status
205 January 5, 2018 Contacts/Locations and Study Status
206 January 8, 2018 Contacts/Locations and Study Status
207 January 9, 2018 Study Status
208 January 10, 2018 Study Status
209 January 11, 2018 Contacts/Locations and Study Status
210 January 12, 2018 Contacts/Locations and Study Status
211 January 16, 2018 Study Status
212 January 17, 2018 Study Status
213 January 18, 2018 Study Status
214 January 19, 2018 Study Status
215 January 31, 2018 Contacts/Locations, Outcome Measures, Study Description and Study Status
216 February 1, 2018 Contacts/Locations and Study Status
217 February 2, 2018 Study Status
218 February 5, 2018 Contacts/Locations and Study Status
219 February 6, 2018 Contacts/Locations and Study Status
220 February 7, 2018 Study Status
221 February 8, 2018 Study Status, Contacts/Locations and Conditions
222 February 9, 2018 Contacts/Locations and Study Status
223 February 12, 2018 Contacts/Locations and Study Status
224 February 13, 2018 Study Status
225 February 14, 2018 Study Status
226 February 15, 2018 Contacts/Locations and Study Status
227 February 16, 2018 Study Status
228 February 19, 2018 Contacts/Locations and Study Status
229 February 20, 2018 Study Status
230 February 22, 2018 Contacts/Locations and Study Status
231 February 23, 2018 Contacts/Locations and Study Status
232 February 26, 2018 Contacts/Locations and Study Status
233 February 27, 2018 Contacts/Locations and Study Status
234 February 28, 2018 Contacts/Locations and Study Status
235 March 1, 2018 Contacts/Locations and Study Status
236 March 2, 2018 Study Status
237 March 5, 2018 Contacts/Locations and Study Status
238 March 6, 2018 Conditions and Study Status
239 March 7, 2018 Contacts/Locations and Study Status
240 March 8, 2018 Contacts/Locations and Study Status
241 March 9, 2018 Contacts/Locations and Study Status
242 March 12, 2018 Contacts/Locations and Study Status
243 March 13, 2018 Study Status
244 March 14, 2018 Contacts/Locations and Study Status
245 March 15, 2018 Contacts/Locations and Study Status
246 March 16, 2018 Study Status
247 March 19, 2018 Contacts/Locations and Study Status
248 March 20, 2018 Contacts/Locations and Study Status
249 March 23, 2018 Study Description and Study Status
250 March 26, 2018 Contacts/Locations and Study Status
251 March 29, 2018 Contacts/Locations and Study Status
252 March 30, 2018 Contacts/Locations and Study Status
253 April 2, 2018 Contacts/Locations and Study Status
254 April 3, 2018 Contacts/Locations and Study Status
255 April 9, 2018 Contacts/Locations and Study Status
256 April 11, 2018 Contacts/Locations and Study Status
257 April 12, 2018 Contacts/Locations and Study Status
258 April 16, 2018 Contacts/Locations and Study Status
259 April 20, 2018 Contacts/Locations and Study Status
260 April 23, 2018 Contacts/Locations and Study Status
261 April 25, 2018 Contacts/Locations and Study Status
262 April 26, 2018 Contacts/Locations and Study Status
263 April 27, 2018 Contacts/Locations and Study Status
264 May 2, 2018 Contacts/Locations and Study Status
265 May 4, 2018 Contacts/Locations and Study Status
266 May 9, 2018 Contacts/Locations and Study Status
267 May 14, 2018 Contacts/Locations and Study Status
268 May 16, 2018 Contacts/Locations and Study Status
269 May 18, 2018 Contacts/Locations and Study Status
270 May 23, 2018 Contacts/Locations and Study Status
271 May 24, 2018 Contacts/Locations and Study Status
272 June 1, 2018 Contacts/Locations and Study Status
273 June 8, 2018 Contacts/Locations and Study Status
274 June 11, 2018 Contacts/Locations and Study Status
275 June 14, 2018 Contacts/Locations and Study Status
276 June 20, 2018 Contacts/Locations and Study Status
277 June 22, 2018 Contacts/Locations and Study Status
278 June 25, 2018 Contacts/Locations and Study Status
279 June 27, 2018 Contacts/Locations and Study Status
280 June 29, 2018 Contacts/Locations and Study Status
281 July 9, 2018 Contacts/Locations and Study Status
282 July 11, 2018 Contacts/Locations and Study Status
283 July 18, 2018 Contacts/Locations and Study Status
284 July 19, 2018 Contacts/Locations and Study Status
285 July 23, 2018 Contacts/Locations and Study Status
286 July 24, 2018 Contacts/Locations and Study Status
287 July 30, 2018 Contacts/Locations and Study Status
288 July 31, 2018 Contacts/Locations and Study Status
289 August 1, 2018 Contacts/Locations and Study Status
290 August 2, 2018 Contacts/Locations and Study Status
291 August 6, 2018 Contacts/Locations and Study Status
292 August 9, 2018 Contacts/Locations and Study Status
293 August 15, 2018 Contacts/Locations and Study Status
294 August 17, 2018 Contacts/Locations and Study Status
295 August 21, 2018 Contacts/Locations and Study Status
296 August 22, 2018 Study Status and Oversight
297 August 24, 2018 Contacts/Locations and Study Status
298 August 27, 2018 Contacts/Locations and Study Status
299 September 3, 2018 Contacts/Locations and Study Status
300 September 7, 2018 Contacts/Locations and Study Status
301 September 10, 2018 Contacts/Locations, Conditions and Study Status
302 September 11, 2018 Contacts/Locations and Study Status
303 September 12, 2018 Contacts/Locations and Study Status
304 September 13, 2018 Contacts/Locations and Study Status
305 September 14, 2018 Contacts/Locations and Study Status
306 September 17, 2018 Contacts/Locations and Study Status
307 September 19, 2018 Contacts/Locations and Study Status
308 September 24, 2018 Contacts/Locations and Study Status
309 September 27, 2018 Contacts/Locations and Study Status
310 September 28, 2018 Contacts/Locations and Study Status
311 October 1, 2018 Contacts/Locations and Study Status
312 October 3, 2018 Contacts/Locations and Study Status
313 October 4, 2018 Contacts/Locations and Study Status
314 October 8, 2018 Contacts/Locations and Study Status
315 October 12, 2018 Contacts/Locations and Study Status
316 October 23, 2018 Contacts/Locations and Study Status
317 October 26, 2018 Contacts/Locations and Study Status
318 October 30, 2018 Contacts/Locations and Study Status
319 October 31, 2018 Contacts/Locations and Study Status
320 November 1, 2018 Contacts/Locations and Study Status
321 November 7, 2018 Contacts/Locations and Study Status
322 November 9, 2018 Contacts/Locations and Study Status
323 November 14, 2018 Contacts/Locations and Study Status
324 November 15, 2018 Contacts/Locations and Study Status
325 November 16, 2018 Contacts/Locations and Study Status
326 December 4, 2018 Contacts/Locations and Study Status
327 December 5, 2018 Contacts/Locations and Study Status
328 December 6, 2018 Contacts/Locations and Study Status
329 December 7, 2018 Contacts/Locations and Study Status
330 December 13, 2018 Contacts/Locations and Study Status
331 December 14, 2018 Contacts/Locations and Study Status
332 December 17, 2018 Contacts/Locations and Study Status
333 December 18, 2018 Contacts/Locations and Study Status
334 December 19, 2018 Contacts/Locations and Study Status
335 December 24, 2018 Contacts/Locations and Study Status
336 December 25, 2018 Study Status
337 December 27, 2018 Contacts/Locations and Study Status
338 January 4, 2019 Contacts/Locations and Study Status
339 January 7, 2019 Contacts/Locations and Study Status
340 January 11, 2019 Contacts/Locations and Study Status
341 January 14, 2019 Contacts/Locations and Study Status
342 January 16, 2019 Contacts/Locations and Study Status
343 January 17, 2019 Contacts/Locations and Study Status
344 January 22, 2019 Contacts/Locations and Study Status
345 January 24, 2019 Contacts/Locations and Study Status
346 January 25, 2019 Contacts/Locations and Study Status
347 January 28, 2019 Contacts/Locations and Study Status
348 January 29, 2019 Contacts/Locations and Study Status
349 January 31, 2019 Contacts/Locations and Study Status
350 February 4, 2019 Contacts/Locations and Study Status
351 February 5, 2019 Contacts/Locations and Study Status
352 February 6, 2019 Contacts/Locations and Study Status
353 February 7, 2019 Contacts/Locations and Study Status
354 February 11, 2019 Contacts/Locations and Study Status
355 February 12, 2019 Contacts/Locations and Study Status
356 February 15, 2019 Contacts/Locations and Study Status
357 February 20, 2019 Contacts/Locations and Study Status
358 February 21, 2019 Contacts/Locations and Study Status
359 February 22, 2019 Contacts/Locations and Study Status
360 February 25, 2019 Contacts/Locations and Study Status
361 February 27, 2019 Contacts/Locations and Study Status
362 February 28, 2019 Contacts/Locations and Study Status
363 March 4, 2019 Contacts/Locations and Study Status
364 March 7, 2019 Contacts/Locations and Study Status
365 March 11, 2019 Contacts/Locations and Study Status
366 March 12, 2019 Contacts/Locations and Study Status
367 March 13, 2019 Contacts/Locations and Study Status
368 March 14, 2019 Contacts/Locations and Study Status
369 March 18, 2019 Contacts/Locations and Study Status
370 March 21, 2019 Contacts/Locations and Study Status
371 March 27, 2019 Contacts/Locations and Study Status
372 April 1, 2019 Contacts/Locations and Study Status
373 April 5, 2019 Contacts/Locations and Study Status
374 April 8, 2019 Contacts/Locations and Study Status
375 April 11, 2019 Contacts/Locations and Study Status
376 April 18, 2019 Contacts/Locations and Study Status
377 April 22, 2019 Contacts/Locations and Study Status
378 April 25, 2019 Contacts/Locations and Study Status
379 April 26, 2019 Contacts/Locations and Study Status
380 May 15, 2019 Contacts/Locations and Study Status
381 May 17, 2019 Contacts/Locations and Study Status
382 May 20, 2019 Contacts/Locations and Study Status
383 May 22, 2019 Contacts/Locations and Study Status
384 June 5, 2019 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Design, Study Description, Eligibility, Conditions and Study Status
385 June 6, 2019 Contacts/Locations and Study Status
386 June 10, 2019 Contacts/Locations and Study Status
387 June 13, 2019 Study Status
388 June 14, 2019 Eligibility, Conditions, Study Description and Study Status
389 June 17, 2019 Contacts/Locations and Study Status
390 June 19, 2019 Contacts/Locations and Study Status
391 June 20, 2019 Contacts/Locations and Study Status
392 July 1, 2019 Contacts/Locations, Study Status, Study Description, Oversight and Eligibility
393 July 3, 2019 Contacts/Locations and Study Status
394 July 5, 2019 Contacts/Locations and Study Status
395 July 8, 2019 Study Status and Conditions
396 July 17, 2019 Contacts/Locations and Study Status
397 July 18, 2019 Contacts/Locations and Study Status
398 July 22, 2019 Contacts/Locations and Study Status
399 July 25, 2019 Contacts/Locations and Study Status
400 July 29, 2019 Contacts/Locations and Study Status
401 August 1, 2019 Contacts/Locations and Study Status
402 August 2, 2019 Contacts/Locations and Study Status
403 August 5, 2019 Contacts/Locations and Study Status
404 August 6, 2019 Contacts/Locations and Study Status
405 August 7, 2019 Contacts/Locations and Study Status
406 August 8, 2019 Contacts/Locations and Study Status
407 August 9, 2019 Contacts/Locations and Study Status
408 August 12, 2019 Contacts/Locations and Study Status
409 August 13, 2019 Contacts/Locations and Study Status
410 August 14, 2019 Contacts/Locations and Study Status
411 August 16, 2019 Contacts/Locations and Study Status
412 August 19, 2019 Contacts/Locations and Study Status
413 August 20, 2019 Contacts/Locations and Study Status
414 August 21, 2019 Contacts/Locations and Study Status
415 August 22, 2019 Contacts/Locations and Study Status
416 August 26, 2019 Contacts/Locations and Study Status
417 August 27, 2019 Contacts/Locations and Study Status
418 August 28, 2019 Contacts/Locations and Study Status
419 August 29, 2019 Contacts/Locations and Study Status
420 August 30, 2019 Contacts/Locations and Study Status
421 September 2, 2019 Contacts/Locations and Study Status
422 September 5, 2019 Contacts/Locations and Study Status
423 September 6, 2019 Contacts/Locations and Study Status
424 September 11, 2019 Contacts/Locations and Study Status
425 September 12, 2019 Contacts/Locations and Study Status
426 September 16, 2019 Contacts/Locations and Study Status
427 September 18, 2019 Contacts/Locations and Study Status
428 September 19, 2019 Contacts/Locations and Study Status
429 September 20, 2019 Contacts/Locations and Study Status
430 September 23, 2019 Contacts/Locations and Study Status
431 September 25, 2019 Contacts/Locations and Study Status
432 September 26, 2019 Contacts/Locations and Study Status
433 September 27, 2019 Contacts/Locations and Study Status
434 October 2, 2019 Study Status and Contacts/Locations
435 October 3, 2019 Contacts/Locations and Study Status
436 October 4, 2019 Contacts/Locations and Study Status
437 October 10, 2019 Contacts/Locations and Study Status
438 October 11, 2019 Contacts/Locations and Study Status
439 October 14, 2019 Contacts/Locations and Study Status
440 October 16, 2019 Contacts/Locations and Study Status
441 October 17, 2019 Contacts/Locations and Study Status
442 October 21, 2019 Contacts/Locations and Study Status
443 October 23, 2019 Contacts/Locations and Study Status
444 October 29, 2019 Contacts/Locations and Study Status
445 October 30, 2019 Contacts/Locations and Study Status
446 October 31, 2019 Contacts/Locations and Study Status
447 November 5, 2019 Contacts/Locations and Study Status
448 November 6, 2019 Contacts/Locations and Study Status
449 November 8, 2019 Contacts/Locations and Study Status
450 November 11, 2019 Contacts/Locations and Study Status
451 November 13, 2019 Contacts/Locations and Study Status
452 November 14, 2019 Recruitment Status, Study Status and Contacts/Locations
453 November 15, 2019 Study Status
454 November 20, 2019 Study Status
455 November 22, 2019 Contacts/Locations and Study Status
456 December 11, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
457 December 13, 2019 Contacts/Locations and Study Status
458 December 16, 2019 Contacts/Locations and Study Status
459 December 19, 2019 Study Status
460 December 20, 2019 Contacts/Locations, Study Description and Study Status
461 December 23, 2019 Contacts/Locations and Study Status
462 December 26, 2019 Contacts/Locations and Study Status
463 January 1, 2020 Contacts/Locations and Study Status
464 January 6, 2020 Contacts/Locations and Study Status
465 January 7, 2020 Contacts/Locations and Study Status
466 January 9, 2020 Contacts/Locations and Study Status
467 January 15, 2020 Contacts/Locations and Study Status
468 January 17, 2020 Contacts/Locations and Study Status
469 January 20, 2020 Study Status
470 January 22, 2020 Contacts/Locations and Study Status
471 January 27, 2020 Contacts/Locations and Study Status
472 January 30, 2020 Contacts/Locations and Study Status
473 January 31, 2020 Contacts/Locations and Study Status
474 February 3, 2020 Contacts/Locations and Study Status
475 February 5, 2020 Contacts/Locations and Study Status
476 February 7, 2020 Contacts/Locations and Study Status
477 February 10, 2020 Contacts/Locations and Study Status
478 February 17, 2020 Contacts/Locations and Study Status
479 February 18, 2020 Contacts/Locations and Study Status
480 February 19, 2020 Contacts/Locations and Study Status
481 February 21, 2020 Contacts/Locations and Study Status
482 February 24, 2020 Contacts/Locations and Study Status
483 February 28, 2020 Contacts/Locations and Study Status
484 March 2, 2020 Contacts/Locations and Study Status
485 March 5, 2020 Contacts/Locations and Study Status
486 March 6, 2020 Contacts/Locations and Study Status
487 March 11, 2020 Contacts/Locations and Study Status
488 March 17, 2020 Contacts/Locations and Study Status
489 March 18, 2020 Contacts/Locations and Study Status
490 March 20, 2020 Contacts/Locations and Study Status
491 April 2, 2020 Contacts/Locations and Study Status
492 April 3, 2020 Contacts/Locations and Study Status
493 April 9, 2020 Contacts/Locations and Study Status
494 April 11, 2020 Contacts/Locations and Study Status
495 April 15, 2020 Contacts/Locations and Study Status
496 April 16, 2020 Contacts/Locations and Study Status
497 April 21, 2020 Contacts/Locations and Study Status
498 April 23, 2020 Contacts/Locations and Study Status
499 April 24, 2020 Contacts/Locations and Study Status
500 April 25, 2020 Contacts/Locations and Study Status
501 April 28, 2020 Contacts/Locations and Study Status
502 April 30, 2020 Contacts/Locations and Study Status
503 May 2, 2020 Contacts/Locations and Study Status
504 May 6, 2020 Contacts/Locations and Study Status
505 May 13, 2020 Contacts/Locations and Study Status
506 May 19, 2020 Contacts/Locations and Study Status
507 May 27, 2020 Contacts/Locations and Study Status
508 May 30, 2020 Contacts/Locations and Study Status
509 June 3, 2020 Contacts/Locations and Study Status
510 June 6, 2020 Contacts/Locations and Study Status
511 June 11, 2020 Contacts/Locations and Study Status
512 June 17, 2020 Contacts/Locations and Study Status
513 June 19, 2020 Contacts/Locations and Study Status
514 June 23, 2020 Contacts/Locations and Study Status
515 June 24, 2020 Contacts/Locations and Study Status
516 June 25, 2020 Contacts/Locations and Study Status
517 June 26, 2020 Contacts/Locations and Study Status
518 June 27, 2020 Contacts/Locations and Study Status
519 July 1, 2020 Contacts/Locations and Study Status
520 July 9, 2020 Contacts/Locations and Study Status
521 July 14, 2020 Contacts/Locations and Study Status
522 July 15, 2020 Contacts/Locations and Study Status
523 July 18, 2020 Contacts/Locations and Study Status
524 July 29, 2020 Contacts/Locations and Study Status
525 July 30, 2020 Contacts/Locations and Study Status
526 July 31, 2020 Contacts/Locations and Study Status
527 August 4, 2020 Contacts/Locations and Study Status
528 August 5, 2020 Contacts/Locations and Study Status
529 August 6, 2020 Contacts/Locations and Study Status
530 August 7, 2020 Contacts/Locations and Study Status
531 August 8, 2020 Contacts/Locations and Study Status
532 August 11, 2020 Contacts/Locations and Study Status
533 August 19, 2020 Study Status, Contacts/Locations, Study Description, Eligibility, Outcome Measures, Arms and Interventions, Conditions and Oversight
534 August 27, 2020 Study Status
535 August 28, 2020 Contacts/Locations and Study Status
536 August 29, 2020 Contacts/Locations and Study Status
537 September 1, 2020 Contacts/Locations and Study Status
538 September 5, 2020 Contacts/Locations and Study Status
539 September 10, 2020 Contacts/Locations and Study Status
540 September 11, 2020 Contacts/Locations and Study Status
541 September 12, 2020 Contacts/Locations and Study Status
542 September 15, 2020 Contacts/Locations and Study Status
543 September 17, 2020 Contacts/Locations and Study Status
544 September 19, 2020 Contacts/Locations and Study Status
545 September 23, 2020 Contacts/Locations and Study Status
546 September 24, 2020 Contacts/Locations and Study Status
547 September 29, 2020 Contacts/Locations and Study Status
548 October 7, 2020 Contacts/Locations and Study Status
549 October 9, 2020 Contacts/Locations and Study Status
550 October 10, 2020 Contacts/Locations and Study Status
551 October 13, 2020 Contacts/Locations and Study Status
552 October 14, 2020 Contacts/Locations and Study Status
553 October 15, 2020 Contacts/Locations and Study Status
554 October 16, 2020 Contacts/Locations and Study Status
555 October 27, 2020 Contacts/Locations and Study Status
556 November 4, 2020 Contacts/Locations, Conditions and Study Status
557 November 10, 2020 Contacts/Locations and Study Status
558 November 12, 2020 Contacts/Locations and Study Status
559 November 14, 2020 Contacts/Locations and Study Status
560 November 19, 2020 Contacts/Locations and Study Status
561 November 20, 2020 Study Status
562 November 21, 2020 Contacts/Locations and Study Status
563 November 24, 2020 Contacts/Locations and Study Status
564 November 25, 2020 Contacts/Locations and Study Status
565 November 26, 2020 Contacts/Locations and Study Status
566 December 1, 2020 Contacts/Locations and Study Status
567 December 12, 2020 Contacts/Locations and Study Status
568 December 19, 2020 Contacts/Locations and Study Status
569 December 22, 2020 Contacts/Locations and Study Status
570 December 24, 2020 Contacts/Locations and Study Status
571 December 31, 2020 Contacts/Locations and Study Status
572 January 5, 2021 Contacts/Locations and Study Status
573 January 6, 2021 Contacts/Locations and Study Status
574 January 9, 2021 Contacts/Locations and Study Status
575 January 13, 2021 Contacts/Locations and Study Status
576 January 19, 2021 Contacts/Locations, Arms and Interventions and Study Status
577 January 21, 2021 Contacts/Locations and Study Status
578 January 23, 2021 Contacts/Locations and Study Status
579 January 30, 2021 Contacts/Locations and Study Status
580 February 3, 2021 Contacts/Locations and Study Status
581 February 6, 2021 Study Status
582 February 12, 2021 Contacts/Locations and Study Status
583 February 13, 2021 Contacts/Locations and Study Status
584 February 18, 2021 Contacts/Locations and Study Status
585 February 19, 2021 Contacts/Locations and Study Status
586 February 20, 2021 Contacts/Locations and Study Status
587 February 26, 2021 Contacts/Locations and Study Status
588 February 27, 2021 Contacts/Locations and Study Status
589 March 3, 2021 Study Status and Contacts/Locations
590 March 11, 2021 Contacts/Locations and Study Status
591 March 25, 2021 Contacts/Locations, Conditions and Study Status
592 March 30, 2021 Contacts/Locations and Study Status
593 April 2, 2021 Study Status
594 April 3, 2021 Study Description and Study Status
595 April 9, 2021 Contacts/Locations and Study Status
596 April 10, 2021 Contacts/Locations and Study Status
597 April 13, 2021 Contacts/Locations and Study Status
598 April 20, 2021 Contacts/Locations and Study Status
599 April 21, 2021 Contacts/Locations and Study Status
600 April 22, 2021 Contacts/Locations and Study Status
601 April 23, 2021 Contacts/Locations and Study Status
602 April 24, 2021 Study Status
603 April 30, 2021 Contacts/Locations and Study Status
604 May 1, 2021 Contacts/Locations and Study Status
605 May 7, 2021 Study Status
606 May 12, 2021 Contacts/Locations and Study Status
607 May 18, 2021 Contacts/Locations and Study Status
608 May 19, 2021 Contacts/Locations and Study Status
609 May 22, 2021 Contacts/Locations and Study Status
610 May 25, 2021 Contacts/Locations and Study Status
611 May 27, 2021 Contacts/Locations and Study Status
612 May 28, 2021 Contacts/Locations and Study Status
613 May 29, 2021 Contacts/Locations and Study Status
614 June 2, 2021 Contacts/Locations and Study Status
615 June 3, 2021 Contacts/Locations and Study Status
616 June 4, 2021 Contacts/Locations and Study Status
617 June 8, 2021 Contacts/Locations, Arms and Interventions and Study Status
618 June 9, 2021 Contacts/Locations and Study Status
619 June 10, 2021 Contacts/Locations and Study Status
620 June 11, 2021 Contacts/Locations and Study Status
621 June 16, 2021 Contacts/Locations and Study Status
622 June 22, 2021 Contacts/Locations and Study Status
623 June 23, 2021 Study Status
624 June 29, 2021 Contacts/Locations and Study Status
625 June 30, 2021 Contacts/Locations and Study Status
626 July 1, 2021 Contacts/Locations and Study Status
627 July 2, 2021 Contacts/Locations and Study Status
628 July 3, 2021 Contacts/Locations and Study Status
629 July 13, 2021 Arms and Interventions and Study Status
630 July 21, 2021 Contacts/Locations and Study Status
631 July 23, 2021 Contacts/Locations and Study Status
632 July 24, 2021 Contacts/Locations and Study Status
633 July 28, 2021 Contacts/Locations and Study Status
634 July 30, 2021 Study Status
635 July 31, 2021 Contacts/Locations and Study Status
636 August 3, 2021 Contacts/Locations and Study Status
637 August 5, 2021 Contacts/Locations and Study Status
638 August 6, 2021 Contacts/Locations and Study Status
639 August 7, 2021 Contacts/Locations and Study Status
640 August 10, 2021 Conditions and Study Status
641 August 11, 2021 Contacts/Locations and Study Status
642 August 12, 2021 Contacts/Locations and Study Status
643 August 17, 2021 Contacts/Locations and Study Status
644 August 18, 2021 Contacts/Locations and Study Status
645 August 19, 2021 Contacts/Locations and Study Status
646 August 24, 2021 Contacts/Locations and Study Status
647 August 26, 2021 Contacts/Locations and Study Status
648 August 27, 2021 Contacts/Locations and Study Status
649 August 31, 2021 Contacts/Locations and Study Status
650 September 8, 2021 Contacts/Locations and Study Status
651 September 10, 2021 Contacts/Locations and Study Status
652 September 14, 2021 Contacts/Locations and Study Status
653 September 15, 2021 Contacts/Locations and Study Status
654 September 16, 2021 Contacts/Locations and Study Status
655 September 18, 2021 Contacts/Locations and Study Status
656 September 21, 2021 Contacts/Locations and Study Status
657 September 25, 2021 Study Status
658 September 30, 2021 Contacts/Locations and Study Status
659 October 6, 2021 Contacts/Locations and Study Status
660 October 8, 2021 Contacts/Locations and Study Status
661 October 12, 2021 Arms and Interventions and Study Status
662 October 13, 2021 Contacts/Locations and Study Status
663 October 14, 2021 Contacts/Locations and Study Status
664 October 16, 2021 Contacts/Locations and Study Status
665 October 20, 2021 Contacts/Locations and Study Status
666 October 22, 2021 Contacts/Locations and Study Status
667 October 28, 2021 Contacts/Locations and Study Status
668 October 30, 2021 Study Status
669 November 2, 2021 Contacts/Locations and Study Status
670 November 3, 2021 Contacts/Locations and Study Status
671 November 9, 2021 Contacts/Locations and Study Status
672 November 10, 2021 Contacts/Locations and Study Status
673 November 12, 2021 Contacts/Locations and Study Status
674 November 13, 2021 Contacts/Locations and Study Status
675 November 16, 2021 Contacts/Locations and Study Status
676 November 18, 2021 Contacts/Locations and Study Status
677 November 19, 2021 Contacts/Locations and Study Status
678 November 25, 2021 Contacts/Locations and Study Status
679 December 1, 2021 Contacts/Locations and Study Status
680 December 9, 2021 Contacts/Locations and Study Status
681 December 11, 2021 Contacts/Locations and Study Status
682 December 14, 2021 Contacts/Locations and Study Status
683 December 21, 2021 Contacts/Locations and Study Status
684 December 22, 2021 Contacts/Locations and Study Status
685 December 23, 2021 Contacts/Locations and Study Status
686 December 29, 2021 Contacts/Locations and Study Status
687 January 4, 2022 Contacts/Locations and Study Status
688 January 6, 2022 Contacts/Locations and Study Status
689 January 8, 2022 Contacts/Locations and Study Status
690 January 11, 2022 Study Status
691 January 14, 2022 Contacts/Locations and Study Status
692 January 18, 2022 Contacts/Locations and Study Status
693 January 20, 2022 Contacts/Locations and Study Status
694 January 27, 2022 Contacts/Locations and Study Status
695 January 28, 2022 Contacts/Locations and Study Status
696 February 2, 2022 Contacts/Locations and Study Status
697 February 3, 2022 Contacts/Locations and Study Status
698 February 5, 2022 Contacts/Locations and Study Status
699 February 8, 2022 Contacts/Locations and Study Status
700 February 9, 2022 Contacts/Locations and Study Status
701 February 11, 2022 Contacts/Locations and Study Status
702 February 18, 2022 Contacts/Locations and Study Status
703 March 2, 2022 Contacts/Locations and Study Status
704 March 5, 2022 Contacts/Locations and Study Status
705 March 9, 2022 Study Status
706 March 11, 2022 Contacts/Locations and Study Status
707 March 18, 2022 Contacts/Locations and Study Status
708 March 19, 2022 Contacts/Locations and Study Status
709 March 22, 2022 Contacts/Locations and Study Status
710 March 23, 2022 Contacts/Locations and Study Status
711 March 25, 2022 Contacts/Locations and Study Status
712 April 2, 2022 Contacts/Locations and Study Status
713 April 5, 2022 Contacts/Locations and Study Status
714 April 20, 2022 Contacts/Locations, Oversight and Study Status
715 April 21, 2022 Contacts/Locations and Study Status
716 April 22, 2022 Contacts/Locations and Study Status
717 April 28, 2022 Study Status
718 April 30, 2022 Contacts/Locations and Study Status
719 May 3, 2022 Conditions and Study Status
720 May 6, 2022 Contacts/Locations and Study Status
721 May 7, 2022 Contacts/Locations and Study Status
722 May 12, 2022 Contacts/Locations and Study Status
723 May 20, 2022 Contacts/Locations and Study Status
724 May 24, 2022 Contacts/Locations and Study Status
725 May 25, 2022 Contacts/Locations and Study Status
726 May 28, 2022 Contacts/Locations and Study Status
727 June 1, 2022 Contacts/Locations and Study Status
728 June 3, 2022 Contacts/Locations and Study Status
729 June 7, 2022 Contacts/Locations, Arms and Interventions and Study Status
730 June 9, 2022 Contacts/Locations and Study Status
731 June 10, 2022 Contacts/Locations and Study Status
732 June 11, 2022 Contacts/Locations and Study Status
733 June 14, 2022 Contacts/Locations and Study Status
734 June 15, 2022 Contacts/Locations and Study Status
735 June 17, 2022 Contacts/Locations and Study Status
736 June 21, 2022 Contacts/Locations and Study Status
737 June 28, 2022 Arms and Interventions and Study Status
738 July 1, 2022 Contacts/Locations and Study Status
739 July 5, 2022 Contacts/Locations and Study Status
740 July 7, 2022 Contacts/Locations and Study Status
741 July 9, 2022 Contacts/Locations and Study Status
742 July 14, 2022 Contacts/Locations and Study Status
743 July 19, 2022 Contacts/Locations and Study Status
744 July 20, 2022 Contacts/Locations and Study Status
745 July 21, 2022 Contacts/Locations and Study Status
746 July 23, 2022 Contacts/Locations and Study Status
747 July 26, 2022 Contacts/Locations and Study Status
748 July 27, 2022 Contacts/Locations and Study Status
749 July 29, 2022 Contacts/Locations and Study Status
750 July 30, 2022 Contacts/Locations and Study Status
751 August 2, 2022 Conditions and Study Status
752 August 4, 2022 Contacts/Locations and Study Status
753 August 5, 2022 Contacts/Locations and Study Status
754 August 9, 2022 Contacts/Locations and Study Status
755 August 10, 2022 Contacts/Locations and Study Status
756 August 12, 2022 Contacts/Locations and Study Status
757 August 16, 2022 Contacts/Locations and Study Status
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Study NCT02834013
Submitted Date:  July 13, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: NCI-2016-01041
Brief Title: Nivolumab and Ipilimumab in Treating Patients With Rare Tumors
Official Title: DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors
Secondary IDs: NCI-2016-01041 [Registry Identifier: CTRP (Clinical Trial Reporting Program)]
S1609
S1609 [SWOG]
U10CA180888 [U.S. NIH Grant/Contract]
Open or close this module Study Status
Record Verification: July 2016
Overall Status: Recruiting
Study Start: June 2016
Primary Completion: August 2020 [Anticipated]
Study Completion:
First Submitted: July 13, 2016
First Submitted that
Met QC Criteria:
July 13, 2016
First Posted: July 15, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
July 13, 2016
Last Update Posted: July 15, 2016 [Estimate]
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:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.
Detailed Description:

PRIMARY OBJECTIVES:

I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy.

SECONDARY OBJECTIVES:

I. To evaluate toxicities in each cohort. II. To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR (irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria.

III. To collect specimens for banking for use in future correlative biomarker research studies.

OUTLINE:

Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 10 years from registration.

Open or close this module Conditions
Conditions: Acinar Cell Carcinoma
Adrenal Cortex Carcinoma
Adrenal Gland Pheochromocytoma
Anal Canal Neuroendocrine Carcinoma
Anal Canal Undifferentiated Carcinoma
Appendix Mucinous Adenocarcinoma
Bladder Adenocarcinoma
Bronchioloalveolar Carcinoma
Cervical Adenocarcinoma
Cervical Squamous Cell Carcinoma, Not Otherwise Specified
Cholangiocarcinoma
Chordoma
Colorectal Squamous Cell Carcinoma
Endometrial Adenocarcinoma
Endometrioid Adenocarcinoma
Esophageal Neuroendocrine Carcinoma
Esophageal Undifferentiated Carcinoma
Extrahepatic Bile Duct Carcinoma
Fallopian Tube Adenocarcinoma
Fibromyxoid Tumor
Gastric Neuroendocrine Carcinoma
Gastric Squamous Cell Carcinoma
Giant Cell Carcinoma
Intestinal Neuroendocrine Carcinoma
Intrahepatic Cholangiocarcinoma
Lung Carcinoid Tumor
Lung Sarcomatoid Carcinoma
Major Salivary Gland Carcinoma
Malignant Odontogenic Neoplasm
Malignant Peripheral Nerve Sheath Tumor
Malignant Skin Neoplasm
Malignant Testicular Sex Cord-Stromal Tumor
Metastatic Malignant Neoplasm of Unknown Primary Origin
Mixed Mesodermal (Mullerian) Tumor
Mucinous Adenocarcinoma
Mucinous Cystadenocarcinoma
Nasal Cavity Adenocarcinoma
Nasal Cavity Carcinoma
Nasopharyngeal Carcinoma
Nasopharyngeal Papillary Adenocarcinoma
Nasopharyngeal Undifferentiated Carcinoma
Oral Cavity Carcinoma
Oropharyngeal Undifferentiated Carcinoma
Ovarian Adenocarcinoma
Ovarian Germ Cell Tumor
Ovarian Mucinous Adenocarcinoma
Ovarian Squamous Cell Carcinoma
Pancreatic Acinar Cell Carcinoma
Pancreatic Neuroendocrine Carcinoma
Paraganglioma
Paranasal Sinus Adenocarcinoma
Paranasal Sinus Carcinoma
Parathyroid Gland Carcinoma
Pituitary Gland Carcinoma
Placental Choriocarcinoma
Placental-Site Gestational Trophoblastic Tumor
Primary Peritoneal High Grade Serous Adenocarcinoma
Pseudomyxoma Peritonei
Scrotal Squamous Cell Carcinoma
Seminal Vesicle Adenocarcinoma
Seminoma
Serous Cystadenocarcinoma
Small Intestinal Adenocarcinoma
Small Intestinal Squamous Cell Carcinoma
Spindle Cell Neoplasm
Squamous Cell Carcinoma of the Penis
Teratoma With Malignant Transformation
Testicular Non-Seminomatous Germ Cell Tumor
Thyroid Gland Carcinoma
Tracheal Carcinoma
Transitional Cell Carcinoma
Undifferentiated Gastric Carcinoma
Ureter Adenocarcinoma
Ureter Squamous Cell Carcinoma
Urethral Adenocarcinoma
Urethral Squamous Cell Carcinoma
Vaginal Adenocarcinoma
Vaginal Squamous Cell Carcinoma, Not Otherwise Specified
Vulvar Adenocarcinoma
Vulvar Squamous Cell Carcinoma
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 334 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Treatment (nivolumab, ipilimumab)
Patients receive nivolumab IV over 30 minutes on days 1, 15, and 29 and ipilimumab IV over 60 minutes on day 1. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
Procedure: Biospecimen Collection
Undergo optional collection of biopsy tissue and blood
Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
Open or close this module Outcome Measures
Primary Outcome Measures:
1. ORR defined as confirmed and unconfirmed complete and partial response, assessed by RECIST 1.1
[ Time Frame: Up to 10 years ]

Secondary Outcome Measures:
1. Best response calculated from the sequence of RECIST 1.1 and immune-related response criteria (irRC) objectives
[ Time Frame: Up to 10 years ]

Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
2. Clinical benefit rate defined as complete response, partial response, or stable disease, estimated using both RECIST and irRC
[ Time Frame: 6 months ]

Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
3. Incidence of adverse events graded by NCI CTCAE version 4.0
[ Time Frame: Up to 10 years ]

Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
4. OS, estimated using both RECIST and irRC
[ Time Frame: From date of registration to date of death due to any cause, assessed up to 10 years ]

Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
5. PFS, estimated using both RECIST and irRC
[ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration or death, assessed up to 10 years ]

Assuming 16 eligible patients per stratum, this will be sufficient to estimate each binary version of this endpoint within +/- 25% (95% confidence interval).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Patients must have histologically confirmed rare cancer and/or cancer of unknown primary, that did not have a match to a molecularly-guided therapy on EAY131 "National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)" protocol or who progressed on molecularly-matched therapy and have no further molecularly-matched treatment recommendations per EAY131, "NCI-MATCH"
    • All baseline assessments must have been completed within 28 days prior to registration
  • Patients that do not qualify for one of the histologic cohorts may be considered for registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation of the study chairs via email
  • Patients that are determined to have a rare cancer with unknown primary site are eligible provided that there is histologic documentation of metastatic malignancy with no discernible primary site identified from histopathologic review, physical exam and associated cross-sectional imaging of the chest, abdomen, and pelvis
  • Patients must have a diagnostic quality computed tomography (CT) scan or magnetic resonance imaging (MRI), performed within 28 days prior to registration, which demonstrates measurable disease, as defined in RECIST v. 1.1; additionally, CT scans or MRIs used to assess non-measurable disease must have been completed within 42 days prior to registration; all disease must be assessed and documented on the S1609 Baseline Tumor Assessment Form
  • No other prior malignancy is allowed except for the following:
    • Adequately managed stage I or II cancer from which the patient is currently in complete remission
    • Any other cancer from which the patient has been disease free for five years
    • Adequately managed stage I or II follicular thyroid or prostate cancer is also eligible, wherein patient is not required to be in complete remission
  • Patients who have received prior anti-programmed death-1(PD-1) or anti-programmed death-ligand 1(PD-L1) therapy are not eligible; other immunotherapy is permitted: including ipilimumab, other anti-cytotoxic T-lymphocyte antigen-4 (CTLA-4), and cancer vaccine therapy provided that it is completed >= 7 days prior to registration
  • Patients who had prior immune-related adverse event (grade 3 or higher immune-related pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer vaccine, cytokine, etc.) are not eligible
  • Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy >= 28 days prior to registration and have stable disease at time of registration; metastatic brain parenchymal disease must have been treated and patient must be off steroids for 7 days prior to registration
  • Patients must not currently be receiving any other investigational agents or any other systemic anti-cancer therapy (including radiation); in event patient recently received any other systemic anti-cancer therapy, patient must be off therapy at least 7 days prior to registration and any therapy-induced toxicity must have recovered to =< grade 1
  • Patients must have a Zubrod performance status of 0-2
  • ANC >= 1,000/mcL
  • Platelets >= 75,000/mcL
  • Hemoglobin >= 8 g/dL
  • Total bilirubin =< 2.0 x institutional upper limit of normal (IULN) or for documented/suspected Gilbert's disease
  • Total bilirubin =< 3.0 x IULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 3 x IULN
  • Serum creatinine =< 2.0 IULN
  • Creatinine clearance (CrCl) >= 50 mL/min., as estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based on actual body weight
  • Patients must have adequate thyroid function, as evidenced by thyroid-stimulating hormone (TSH), free thyroxine (T4) serum tests demonstrating values within the normal range, within 28 days prior to registration; Note: TSH, with reflex T4 is allowable if per institutional standard; otherwise, both TSH and free-T4 must be obtained
  • Patients must have adequate adrenal axis function, as evidenced by Adrenocorticotropic Hormone (ACTH) values within the normal ranges, within 28 days prior to registration
  • Females of childbearing potential must have negative serum pregnancy test 14 days prior to registration and agree to use birth control throughout study and for 23 weeks after completion of protocol therapy; patients must not be pregnant or nursing; women/men of reproductive potential must have agreed to use an effective contraceptive method; a woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months; in addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV) infection at time of registration; patients with HBV or HCV that have an undetectable viral load, or in the opinion of the treating investigator is well-controlled, are eligible
  • Patients who are known to be human immunodeficiency virus (HIV)-positive at registration are eligible at the time of registration:
    1. Cluster of differentiation (CD)4+ cell count greater or equal to 250 cells/mm^3
    2. If patient is on antiretroviral therapy, there must be minimal interactions or overlapping toxicity of the antiretroviral therapy with the experimental cancer treatment; once daily combinations that use pharmacologic boosters may not be used
    3. No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining conditions other than historical low CD4+ cell counts
    4. Probable long-term survival with HIV if cancer were not present
  • Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10mg or equivalent). 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. Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease, multiple sclerosis, vasculitis, or glomerulonephritis; patients with well-controlled systemic lupus erythematous or rheumatoid arthritis may be eligible after communication with the study chairs at S1609SC@swog.org; vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 3 years is permitted; short-term steroid premedication for contrast allergy is permitted
  • Patients must not have any uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>= grade 3)
Open or close this module Contacts/Locations
Study Officials: Sandip Patel
Principal Investigator
Southwest Oncology Group
Locations: United States, Oregon
SWOG
[Recruiting]
Portland, Oregon, United States, 97239
Contact:Contact: Sandip P. Patel 858-822-2372 sandippatel@ucsd.edu
Contact:Principal Investigator: Sandip P. Patel
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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