Actively Recruiting
DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer
Led by AstraZeneca · Updated on 2026-05-06
600
Participants Needed
250
Research Sites
307 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
D
Daiichi Sankyo Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
DESTINY-Endometrial01 will investigate the efficacy of first-line T-DXd + rilvegostomig (Arm A) and/or T-DXd+ pembrolizumab (Arm B) when compared to chemotherapy (carboplatin + paclitaxel) + pembrolizumab (Arm C), by assessment of progression free survival (PFS), as assessed by BICR, in participants with HER2-expressing (IHC 3+/2+), pMMR, primary advanced (Stage III/IV) or recurrent EC.
CONDITIONS
Official Title
DESTINY-Endometrial01: A Phase III Study of Trastuzumab Deruxtecan Plus Rilvegostomig or Pembrolizumab as First-Line Treatment of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR) Endometrial Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older.
- Histologically confirmed epithelial endometrial carcinoma; all histologies allowed except sarcomas (carcinosarcomas allowed).
- Primary advanced disease (Stage III/IV) or first recurrent endometrial cancer with measurable disease or as defined.
- HER2 expression of 3+ or 2+ by central testing.
- Mismatch repair proficient (pMMR) by central testing.
- Adequate tumor tissue sample available for testing.
- Naive to first-line systemic anticancer therapy; prior adjuvant/neoadjuvant chemotherapy allowed if recurrence occurred 6 months or more after last dose.
- No prior antibody-drug conjugate (ADC) or immune checkpoint inhibitor therapy.
- Prior radiation therapy allowed with adequate washout.
- Eastern Cooperative Oncology Group performance status 0-1.
- Left ventricular ejection fraction 50% or higher within 28 days before randomization.
- Adequate organ and bone marrow function within 14 days before randomization.
You will not qualify if you...
- History of organ transplant.
- Uncontrolled illness including active infection, serious gastrointestinal conditions with diarrhea, or active skin disease requiring systemic treatment.
- Spinal cord compression or active central nervous system metastases.
- Recent myocardial infarction within 6 months, symptomatic congestive heart failure (NYHA Class II-IV), significant arrhythmia, or cardiomyopathy.
- Elevated troponin levels at screening without cardiology clearance.
- History or current interstitial lung disease (ILD)/pneumonitis requiring steroids or suspected ILD not ruled out by imaging.
- Significant lung disorders such as recent pulmonary emboli, severe asthma, COPD, restrictive lung disease, or pleural effusion.
- Autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement.
- Prior complete pneumonectomy.
- Active or prior autoimmune or inflammatory disorders needing chronic immunosuppressive treatment.
- Active primary immunodeficiency or infectious diseases including tuberculosis, uncontrolled HIV, or chronic active hepatitis B or C (with exceptions for controlled hepatitis B).
- Concurrent anticancer treatment without adequate washout period; hormonal therapy for non-cancer conditions is allowed.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 250 locations
1
Research Site
Tucson, Arizona, United States, 85704
Withdrawn
2
Research Site
Little Rock, Arkansas, United States, 72205
Actively Recruiting
3
Research Site
Duarte, California, United States, 91010
Not Yet Recruiting
4
Research Site
Irvine, California, United States, 92618
Not Yet Recruiting
5
Research Site
La Jolla, California, United States, 92037
Actively Recruiting
6
Research Site
Palo Alto, California, United States, 94304
Withdrawn
7
Research Site
San Francisco, California, United States, 94143
Suspended
8
Research Site
Sylmar, California, United States, 91342
Withdrawn
9
Research Site
Fort Myers, Florida, United States, 33901
Actively Recruiting
10
Research Site
Miami Beach, Florida, United States, 33140
Actively Recruiting
11
Research Site
Orlando, Florida, United States, 32804
Not Yet Recruiting
12
Research Site
St. Petersburg, Florida, United States, 33705
Actively Recruiting
13
Research Site
Tampa, Florida, United States, 33612
Actively Recruiting
14
Research Site
West Palm Beach, Florida, United States, 33401
Actively Recruiting
15
Research Site
Augusta, Georgia, United States, 30912
Actively Recruiting
16
Research Site
Honolulu, Hawaii, United States, 96813
Withdrawn
17
Research Site
Arlington Heights, Illinois, United States, 60005
Actively Recruiting
18
Research Site
Evanston, Illinois, United States, 60201
Actively Recruiting
19
Research Site
Shreveport, Louisiana, United States, 71103
Actively Recruiting
20
Research Site
Baltimore, Maryland, United States, 21201
Actively Recruiting
21
Research Site
Boston, Massachusetts, United States, 02111
Actively Recruiting
22
Research Site
Worcester, Massachusetts, United States, 01655
Withdrawn
23
Research Site
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
24
Research Site
Detroit, Michigan, United States, 48201
Withdrawn
25
Research Site
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
26
Research Site
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
27
Research Site
Jackson, Mississippi, United States, 39216
Actively Recruiting
28
Research Site
Springfield, Missouri, United States, 65804
Not Yet Recruiting
29
Research Site
St Louis, Missouri, United States, 63141
Actively Recruiting
30
Research Site
Las Vegas, Nevada, United States, 89169
Withdrawn
31
Research Site
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
32
Research Site
Hackensack, New Jersey, United States, 07601
Not Yet Recruiting
33
Research Site
Albuquerque, New Mexico, United States, 87109
Not Yet Recruiting
34
Research Site
New York, New York, United States, 10016
Withdrawn
35
Research Site
New York, New York, United States, 10065
Actively Recruiting
36
Research Site
New York, New York, United States, 10075
Withdrawn
37
Research Site
Charlotte, North Carolina, United States, 28204
Actively Recruiting
38
Research Site
Charlotte, North Carolina, United States, 28204
Not Yet Recruiting
39
Research Site
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
40
Research Site
Winston-Salem, North Carolina, United States, 27157
Not Yet Recruiting
41
Research Site
Cincinnati, Ohio, United States, 45220
Actively Recruiting
42
Research Site
Columbus, Ohio, United States, 43210
Not Yet Recruiting
43
Research Site
Oklahoma City, Oklahoma, United States, 73104
Not Yet Recruiting
44
Research Site
Tulsa, Oklahoma, United States, 74134
Withdrawn
45
Research Site
Eugene, Oregon, United States, 97401
Actively Recruiting
46
Research Site
Abington, Pennsylvania, United States, 19001
Withdrawn
47
Research Site
Hershey, Pennsylvania, United States, 17033
Withdrawn
48
Research Site
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
49
Research Site
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
50
Research Site
Providence, Rhode Island, United States, 02905
Actively Recruiting
51
Research Site
Charleston, South Carolina, United States, 29425
Actively Recruiting
52
Research Site
Sioux Falls, South Dakota, United States, 57105
Actively Recruiting
53
Research Site
Austin, Texas, United States, 78758
Actively Recruiting
54
Research Site
Fort Worth, Texas, United States, 76104
Actively Recruiting
55
Research Site
Houston, Texas, United States, 77030
Actively Recruiting
56
Research Site
San Antonio, Texas, United States, 78240
Actively Recruiting
57
Research Site
Charlottesville, Virginia, United States, 22908
Actively Recruiting
58
Research Site
Fairfax, Virginia, United States, 22031
Not Yet Recruiting
59
Research Site
Seattle, Washington, United States, 98133
Withdrawn
60
Research Site
Madison, Wisconsin, United States, 53792
Actively Recruiting
61
Research Site
Blacktown, Australia, 2148
Actively Recruiting
62
Research Site
East Melbourne, Australia, 3002
Actively Recruiting
63
Research Site
Nedlands, Australia, 6009
Actively Recruiting
64
Research Site
South Brisbane, Australia, 4101
Actively Recruiting
65
Research Site
Innsbruck, Austria, 6020
Not Yet Recruiting
66
Research Site
Linz, Austria, 4021
Not Yet Recruiting
67
Research Site
Vienna, Austria, 1090
Not Yet Recruiting
68
Research Site
Wein, Austria, 1130
Not Yet Recruiting
69
Research Site
Anderlecht, Belgium, 1070
Not Yet Recruiting
70
Research Site
Brussels, Belgium, 1200
Actively Recruiting
71
Research Site
Charleroi, Belgium, 6060
Withdrawn
72
Research Site
Ghent, Belgium, 9000
Actively Recruiting
73
Research Site
Leuven, Belgium, 3000
Actively Recruiting
74
Research Site
Liège, Belgium, 4000
Actively Recruiting
75
Research Site
Barretos, Brazil, 14784-057
Actively Recruiting
76
Research Site
Belo Horizonte, Brazil, 30130 100
Actively Recruiting
77
Research Site
Goiânia, Brazil, 74000-000
Actively Recruiting
78
Research Site
Londrina, Brazil, 86015-520
Actively Recruiting
79
Research Site
Porto Alegre, Brazil, 90020-090
Actively Recruiting
80
Research Site
Porto Alegre, Brazil, 90610000
Actively Recruiting
81
Research Site
Rio de Janeiro, Brazil, 20220-410
Actively Recruiting
82
Research Site
Salvador, Brazil, 41.950-610
Actively Recruiting
83
Research Site
São Paulo, Brazil, 01246-000
Actively Recruiting
84
Research Site
São Paulo, Brazil, 01317-001
Actively Recruiting
85
Research Site
São Paulo, Brazil, 1409
Actively Recruiting
86
Research Site
Teresina, Brazil, 64049-200
Actively Recruiting
87
Research Site
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
88
Research Site
Edmonton, Alberta, Canada, T6G 1Z2
Actively Recruiting
89
Research Site
Winnipeg, Manitoba, Canada, R3E 0V9
Withdrawn
90
Research Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Withdrawn
91
Research Site
London, Ontario, Canada, N6A 4L6
Actively Recruiting
92
Research Site
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
93
Research Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
94
Research Site
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
95
Research Site
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
96
Research Site
Montreal, Quebec, Canada, H3G 1A4
Actively Recruiting
97
Research Site
Québec, Quebec, Canada, G1J 1Z4
Actively Recruiting
98
Research Site
Beijing, China, 100142
Actively Recruiting
99
Research Site
Changchun, China, 130021
Actively Recruiting
100
Research Site
Changsha, China, 410013
Actively Recruiting
101
Research Site
Chengdu, China, 610041
Actively Recruiting
102
Research Site
Chengdu, China, 610072
Actively Recruiting
103
Research Site
Chongqing, China, 400030
Actively Recruiting
104
Research Site
Fuzhou, China, 350001
Actively Recruiting
105
Research Site
Fuzhou, China, 350014
Actively Recruiting
106
Research Site
Guangzhou, China, 510060
Actively Recruiting
107
Research Site
Guangzhou, China, 510080
Actively Recruiting
108
Research Site
Guangzhou, China, 510120
Actively Recruiting
109
Research Site
Haikou, China, 570311
Actively Recruiting
110
Research Site
Hangzhou, China, 310022
Actively Recruiting
111
Research Site
Harbin, China, 150049
Actively Recruiting
112
Research Site
Hefei, China, 230001
Actively Recruiting
113
Research Site
Jinan, China, 250021
Actively Recruiting
114
Research Site
Jinan, China, 250117
Actively Recruiting
115
Research Site
Jining, China, 272029
Actively Recruiting
116
Research Site
Kunming, China, 650118
Actively Recruiting
117
Research Site
Lanzhou, China, 730030
Actively Recruiting
118
Research Site
Nanchang, China, 330006
Withdrawn
119
Research Site
Nanning, China, 530021
Actively Recruiting
120
Research Site
Shanghai, China, 200011
Actively Recruiting
121
Research Site
Shanghai, China, 201318
Actively Recruiting
122
Research Site
Shantou, China
Actively Recruiting
123
Research Site
Shenyang, China, 110004
Actively Recruiting
124
Research Site
Shenyang, China, 110042
Actively Recruiting
125
Research Site
Taiyuan, China, 030001
Actively Recruiting
126
Research Site
Tianjin, China, 300060
Actively Recruiting
127
Research Site
Ürümqi, China, 830000
Withdrawn
128
Research Site
Wuhan, China, 430000
Actively Recruiting
129
Research Site
Wuhan, China, 430022
Actively Recruiting
130
Research Site
Xi'an, China, 710061
Actively Recruiting
131
Research Site
Xuzhou, China, 221009
Actively Recruiting
132
Research Site
Yibin, China, 610500
Withdrawn
133
Research Site
Aalborg, Denmark, 9100
Not Yet Recruiting
134
Research Site
Herlev, Denmark, 2730
Withdrawn
135
Research Site
København Ø, Denmark, 2100
Not Yet Recruiting
136
Research Site
Odense, Denmark, 5000
Not Yet Recruiting
137
Research Site
Helsinki, Finland, 00290
Actively Recruiting
138
Research Site
Oulu, Finland, 90029
Not Yet Recruiting
139
Research Site
Tampere, Finland, 33520
Actively Recruiting
140
Research Site
Turku, Finland, 20521
Actively Recruiting
141
Research Site
Besançon, France, 25030
Withdrawn
142
Research Site
Bordeaux, France, 33076
Not Yet Recruiting
143
Research Site
Caen, France, 14076
Actively Recruiting
144
Research Site
Clermont-Ferrand, France, 63000
Actively Recruiting
145
Research Site
Lyon, France, 69373
Actively Recruiting
146
Research Site
Montpellier, France, 34298
Actively Recruiting
147
Research Site
Nice, France, 06100
Actively Recruiting
148
Research Site
Paris, France, 75015
Actively Recruiting
149
Research Site
Plérin, France, 22190
Actively Recruiting
150
Research Site
Poitiers, France, 86021
Actively Recruiting
151
Research Site
Saint-Herblain, France, 44805
Not Yet Recruiting
152
Research Site
Toulouse, France, 31059
Actively Recruiting
153
Research Site
Berlin, Germany, 13353
Not Yet Recruiting
154
Research Site
Chemnitz, Germany, 09116
Not Yet Recruiting
155
Research Site
Dessau, Germany, 06847
Not Yet Recruiting
156
Research Site
Dresden, Germany, 01307
Not Yet Recruiting
157
Research Site
Essen, Germany, 45147
Not Yet Recruiting
158
Research Site
Hamburg, Germany, 20246
Not Yet Recruiting
159
Research Site
Kassel, Germany, 34125
Not Yet Recruiting
160
Research Site
Leipzig, Germany, 04103
Not Yet Recruiting
161
Research Site
Mannheim, Germany, 68167
Not Yet Recruiting
162
Research Site
Marburg, Germany, 35043
Withdrawn
163
Research Site
Münster, Germany, 48149
Not Yet Recruiting
164
Research Site
Saarbrücken, Germany, 66113
Not Yet Recruiting
165
Research Site
Budapest, Hungary, 1088
Actively Recruiting
166
Research Site
Budapest, Hungary, 1122
Actively Recruiting
167
Research Site
Debrecen, Hungary, 4032
Actively Recruiting
168
Research Site
Catania, Italy, 95100
Actively Recruiting
169
Research Site
Florence, Italy, 50134
Actively Recruiting
170
Research Site
Milan, Italy, 20141
Actively Recruiting
171
Research Site
Milan, Italy, 20159
Actively Recruiting
172
Research Site
Milan, Italy, 20162
Actively Recruiting
173
Research Site
Monza, Italy, 20900
Not Yet Recruiting
174
Research Site
Naples, Italy, 80131
Actively Recruiting
175
Research Site
Reggio Emilia, Italy, 422122
Not Yet Recruiting
176
Research Site
Roma, Italy, 00144
Actively Recruiting
177
Research Site
Rome, Italy, 00168
Actively Recruiting
178
Research Site
Torino, Italy, 10128
Actively Recruiting
179
Research Site
Turin, Italy, 10128
Actively Recruiting
180
Research Site
Akashi-shi, Japan, 673-8558
Withdrawn
181
Research Site
Ginowan-shi, Japan, 901-2725
Actively Recruiting
182
Research Site
Hidaka-shi, Japan, 350-1298
Actively Recruiting
183
Research Site
Isehara-shi, Japan, 259-1193
Actively Recruiting
184
Research Site
Kashiwa, Japan, 227-8577
Not Yet Recruiting
185
Research Site
Kashiwa-shi, Japan, 277-8567
Actively Recruiting
186
Research Site
Kobe, Japan, 650-0047
Actively Recruiting
187
Research Site
Kōtoku, Japan, 135-8550
Actively Recruiting
188
Research Site
Kurume-shi, Japan, 830-0011
Actively Recruiting
189
Research Site
Matsuyama, Japan, 791-0280
Actively Recruiting
190
Research Site
Morioka, Japan, 028-3695
Actively Recruiting
191
Research Site
Nagoya, Japan, 464-8681
Not Yet Recruiting
192
Research Site
Niigata, Japan, 951-8520
Actively Recruiting
193
Research Site
Osaka, Japan, 541-8567
Actively Recruiting
194
Research Site
Ota-shi, Japan, 373-8550
Actively Recruiting
195
Research Site
Sapporo, Japan, 060-8638
Actively Recruiting
196
Research Site
Sendai, Japan, 980-8574
Actively Recruiting
197
Research Site
Shinjuku-ku, Japan, 160-8582
Actively Recruiting
198
Research Site
Sunto-gun, Japan, 411-8777
Actively Recruiting
199
Research Site
Tokyo, Japan, 104-0045
Actively Recruiting
200
Research Site
Yokohama, Japan, 241-8515
Not Yet Recruiting
201
Research Site
Amsterdam, Netherlands, 1066CX
Withdrawn
202
Research Site
Leiden, Netherlands, 2333 ZA
Withdrawn
203
Research Site
Nijmegen, Netherlands, 6525 GA
Withdrawn
204
Research Site
Rotterdam, Netherlands, 3015 GD
Withdrawn
205
Research Site
Oslo, Norway, 0379
Actively Recruiting
206
Research Site
Stavanger, Norway, 4011
Actively Recruiting
207
Research Site
Bialystok, Poland, 15-027
Actively Recruiting
208
Research Site
Gdansk, Poland, 80-214
Actively Recruiting
209
Research Site
Lodz, Poland, 93-338
Actively Recruiting
210
Research Site
Poznan, Poland, 60-569
Actively Recruiting
211
Research Site
Siedlce, Poland, 08-110
Actively Recruiting
212
Research Site
Szczecin, Poland, 70-111
Not Yet Recruiting
213
Research Site
Goyang-si, South Korea, 10408
Actively Recruiting
214
Research Site
Seoul, South Korea, 03080
Actively Recruiting
215
Research Site
Seoul, South Korea, 03722
Actively Recruiting
216
Research Site
Seoul, South Korea, 05505
Actively Recruiting
217
Research Site
Seoul, South Korea, 06351
Actively Recruiting
218
Research Site
Suwon, South Korea, 16499
Actively Recruiting
219
Research Site
A Coruña, Spain, 15009
Actively Recruiting
220
Research Site
Córdoba, Spain, 14004
Actively Recruiting
221
Research Site
Donostia / San Sebastian, Spain, 20014
Actively Recruiting
222
Research Site
El Palmar, Spain, 30120
Actively Recruiting
223
Research Site
L'Hospitalet de Llobregat, Spain, 08908
Actively Recruiting
224
Research Site
Madrid, Spain, 28034
Actively Recruiting
225
Research Site
Madrid, Spain, 28041
Actively Recruiting
226
Research Site
Palma de Mallorca, Spain, 07010
Not Yet Recruiting
227
Research Site
Valencia, Spain, 46006
Actively Recruiting
228
Research Site
Valencia, Spain, 46009
Actively Recruiting
229
Research Site
Zaragoza, Spain, 50009
Actively Recruiting
230
Research Site
Linköping, Sweden, 581 85
Actively Recruiting
231
Research Site
Lund, Sweden, 22185
Actively Recruiting
232
Research Site
Stockholm, Sweden, 17164
Actively Recruiting
233
Research Site
Uppsala, Sweden, 751 85
Actively Recruiting
234
Research Site
Frauenfeld, Switzerland, 8501
Withdrawn
235
Research Site
Liestal, Switzerland, CH- 4410
Actively Recruiting
236
Research Site
Sankt Gallen, Switzerland, 9007
Actively Recruiting
237
Research Site
Zurich, Switzerland, 8091
Not Yet Recruiting
238
Research Site
Changhua, Taiwan, 500
Actively Recruiting
239
Research Site
Kaohsiung City, Taiwan, 81362
Actively Recruiting
240
Research Site
New Taipei City, Taiwan, 220
Actively Recruiting
241
Research Site
Taichung, Taiwan, 40705
Actively Recruiting
242
Research Site
Tainan, Taiwan, 704
Actively Recruiting
243
Research Site
Taipei, Taiwan, 10449
Actively Recruiting
244
Research Site
Bath, United Kingdom, BA1 3NG
Actively Recruiting
245
Research Site
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
246
Research Site
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
247
Research Site
London, United Kingdom, EC1A 7BE
Actively Recruiting
248
Research Site
Manchester, United Kingdom, M20 4BX
Actively Recruiting
249
Research Site
Northwood, United Kingdom, HA6 2RN
Actively Recruiting
250
Research Site
Taunton, United Kingdom, TA1 5DA
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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