Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
3 other identifiers
interventional
700
27 countries
301
Brief Summary
This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2025
Typical duration for phase_3
301 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2025
CompletedFirst Posted
Study publicly available on registry
June 30, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 17, 2029
April 13, 2026
April 1, 2026
2.5 years
June 23, 2025
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression Free Survival (PFS) for Arm A vs Arm B
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Approximately 3 years
Overall survival (OS) for Arm A vs Arm B
OS is defined as the time from randomization until the date of death due to any cause.
Approximately 3 years
Secondary Outcomes (7)
Assessment of Overall Response Rate (ORR) for Arm A vs Arm B
Approximately 3 years
Assessment of Duration of response (DoR) for Arm A vs Arm B
Approximately 3 years
Assessment of progression-free survival 2 (PFS2) for Arm A vs Arm B
Approximately 3 years
Time until first subsequent anticancer therapy after discontinuation of the randomized treatment, or death (TFST) for Arm A vs Arm B
Approximately 3 years
Time until the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death (TSST) for Arm A vs Arm B
Approximately 3 years
- +2 more secondary outcomes
Study Arms (2)
Puxitatug Samrotecan
EXPERIMENTALPuxi-Sam IV (intravenous) Q3W .
Chemotherapy
ACTIVE COMPARATORPhysician's choice of chemotherapy Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.
Interventions
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
60 mg/m2 on Day 1 Q3W Route of administration: IV
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
- Recurrent/metastatic EC ie, with radiological or objective evidence of recurrence or progression.
- Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
- A WHO/ECOG performance status of 0 or 1 at Screening.
- Has radiographically measurable disease by RECIST 1.1
You may not qualify if:
- Had uterine sarcomas or uterine neuroendocrine carcinoma.
- Has had a recurrence of endometrial carcinoma or carcinosarcoma more than \> 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting.
- Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs .
- Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent.
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
- Active or previously documented autoimmune or inflammatory disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (307)
Research Site
Tucson, Arizona, 85719, United States
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La Jolla, California, 92037, United States
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Los Angeles, California, 90095, United States
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Orange, California, 92868, United States
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Jupiter, Florida, 33458, United States
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Miami, Florida, 33136, United States
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Miami, Florida, 33176, United States
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Miami Beach, Florida, 33140, United States
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Orlando, Florida, 32806, United States
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West Palm Beach, Florida, 33401, United States
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Honolulu, Hawaii, 96826, United States
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Chicago, Illinois, 60607, United States
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Peoria, Illinois, 61637, United States
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Urbana, Illinois, 61801, United States
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Fort Wayne, Indiana, 46845, United States
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Indianapolis, Indiana, 46260, United States
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Scarborough, Maine, 04074, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21231, United States
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Silver Spring, Maryland, 20910, United States
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Ann Arbor, Michigan, 48109, United States
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Ann Arbor, Michigan, 48197, United States
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Detroit, Michigan, 48201, United States
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Minneapolis, Minnesota, 55404, United States
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Camden, New Jersey, 08103, United States
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Paramus, New Jersey, 07652, United States
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Albuquerque, New Mexico, 87109, United States
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Brooklyn, New York, 11220, United States
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Stony Brook, New York, 11794, United States
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The Bronx, New York, 10461, United States
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White Plains, New York, 10601, United States
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Greenville, North Carolina, 27834, United States
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Pinehurst, North Carolina, 28374, United States
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Cincinnati, Ohio, 45220, United States
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Cleveland, Ohio, 44106, United States
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Cleveland, Ohio, 44109, United States
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Columbus, Ohio, 43219, United States
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Dayton, Ohio, 45459, United States
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Hilliard, Ohio, 43026, United States
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Sylvania, Ohio, 43560, United States
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Portland, Oregon, 97239, United States
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Bethlehem, Pennsylvania, 18015, United States
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Hershey, Pennsylvania, 17033, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Pittsburgh, Pennsylvania, 15224, United States
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Willow Grove, Pennsylvania, 19090, United States
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York, Pennsylvania, 17403, United States
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Sioux Falls, South Dakota, 57104, United States
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Sioux Falls, South Dakota, 57105, United States
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Knoxville, Tennessee, 37920, United States
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Nashville, Tennessee, 37232, United States
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Austin, Texas, 78758, United States
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Houston, Texas, 77030, United States
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Tyler, Texas, 75702, United States
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Fairfax, Virginia, 22031, United States
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Falls Church, Virginia, 22042, United States
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Norfolk, Virginia, 23502, United States
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Richmond, Virginia, 23298, United States
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Roanoke, Virginia, 24016, United States
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Kennewick, Washington, 99336, United States
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Seattle, Washington, 98104, United States
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Morgantown, West Virginia, 26505, United States
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Waukesha, Wisconsin, 53188, United States
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Capital Federal, C1417DTB, Argentina
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Ciudad Autonoma Buenos Aires, 1405, Argentina
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Ciudad de Buenos Aires, C1118AAT, Argentina
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Córdoba, 2356, Argentina
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Córdoba, X5004FHP, Argentina
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Cuidad Autónoma de Buenos Aire, C1426ANZ, Argentina
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La Rioja, 5300, Argentina
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Pergamino, B2700CPM, Argentina
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Viedma, R8500ACE, Argentina
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Malvern, 3144, Australia
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Melbourne, 3000, Australia
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Randwick, 2031, Australia
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St Leonards, 2065, Australia
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Subiaco, 6008, Australia
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Westmead, 2145, Australia
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Vienna, 1090, Austria
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6000, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Belém, 66073-005, Brazil
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Belo Horizonte, 30360-680, Brazil
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Bento Gonçalves, 95700-084, Brazil
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Blumenau, 89010-340, Brazil
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Curitiba, 80510-130, Brazil
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Curitiba, 80810-050, Brazil
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Florianópolis, 88020-210, Brazil
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Natal, 59062-000, Brazil
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Porto Alegre, 90020-090, Brazil
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Porto Alegre, 90470-340, Brazil
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Porto Alegre, 90610-001, Brazil
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Recife, 50070-480, Brazil
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Recife, 52010-075, Brazil
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Ribeirão Preto, 14026-040, Brazil
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Rio de Janeiro, 22281-100, Brazil
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Rio de Janeiro, 22775-001, Brazil
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Salvador, 41950-640, Brazil
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São Caetano do Sul, 09541-270, Brazil
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São Paulo, 01317-000, Brazil
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São Paulo, 01323-000, Brazil
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São Paulo, 01323-020, Brazil
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São Paulo, 01509-900, Brazil
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Sorocaba, 18030-005, Brazil
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Sorocaba, 18052-210, Brazil
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Taubaté, 12030-200, Brazil
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Teresina, 64049-200, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Winnipeg, Manitoba, R3A 1R9, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Beijing, 100021, China
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Beijing, 100026, China
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Beijing, 100044, China
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Beijing, 100730, China
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Changchun, 130021, China
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Changsha, 410011, China
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Changsha, 410013, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Dalian, 116023, China
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Fuzhou, 350014, China
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Guangzhou, 510120, China
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Hangzhou, 310006, China
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Hangzhou, 310022, China
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Jinan, 250012, China
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Jinan, 250117, China
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Nanchang, 330006, China
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Nanjing, 210004, China
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Shanghai, 200011, China
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Shanghai, 200025, China
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Shanghai, 200072, China
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Shenyang, 110004, China
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Shenyang, 110042, China
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Shenzhen, 518116, China
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Shijiazhuang, 050011, China
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Tianjin, 300060, China
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Tianjin, 300110, China
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Wenzhou, 325000, China
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Wuhan, 430022, China
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Wuhan, 430030, China
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Xi'an, 710061, China
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Zhanjiang, 524001, China
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Zhengzhou, 450002, China
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Brno, 625 00, Czechia
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Brno, 656 53, Czechia
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Hradec Králové, 500 05, Czechia
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Nový Jičín, 74101, Czechia
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Ostrava, 708 502, Czechia
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Prague, 12808, Czechia
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Prague, 180 81, Czechia
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V Uvalu 84, 150 06, Czechia
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Herlev, 2730, Denmark
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Kuopio, 70210, Finland
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Tampere, 33520, Finland
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Turku, 20520, Finland
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Avignon, 84918, France
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Besançon, 25000, France
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Bordeaux, 33076, France
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Chambray-lès-Tours, 37170, France
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Cholet, 49300, France
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Créteil, 94010, France
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Grenoble, 38000, France
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Lille, 59000, France
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Limoges, 87042, France
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Lyon, 69008, France
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Nantes, 44000, France
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Nîmes, 30029, France
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Paris, 75014, France
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Paris, 75020, France
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Paris, 75900, France
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Plerin SUR MER, 22190, France
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Rennes, 35000, France
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Toulouse, 31059, France
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Batumi, 6000, Georgia
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Tbilisi, 0159, Georgia
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Tbilisi, 0186, Georgia
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Amberg, 92224, Germany
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Chemnitz, 09116, Germany
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Dresden, 01307, Germany
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Essen, 45130, Germany
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Frankfurt am Main, 60596, Germany
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Freiburg im Breisgau, 79106, Germany
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Hamburg, 20246, Germany
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Heidelberg, 69120, Germany
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Heilbronn, 74078, Germany
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Mainz, 55131, Germany
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Münster, 48149, Germany
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Paderborn, 33161, Germany
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Regensburg, 93053, Germany
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Schwäbisch Hall, 74523, Germany
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Ulm, 89075, Germany
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Witten, 58452, Germany
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Athens, 115 28, Greece
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Athens, 11528, Greece
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Athens, 14564, Greece
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Thessaloniki, 55236, Greece
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Budapest, 1082, Hungary
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Budapest, 1122, Hungary
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Debrecen, 4032, Hungary
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Győr, 9024, Hungary
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Ashdod, 7747629, Israel
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Hadera, 38100, Israel
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Haifa, 3109601, Israel
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Holon, 5822012, Israel
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Jerusalem, 9103102, Israel
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Jerusalem, 9112001, Israel
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Nahariya, 2210001, Israel
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Ramat Gan, 5262000, Israel
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Safed, 13100, Israel
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Tel Aviv, 6423906, Israel
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Alessandria, 15121, Italy
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Aviano, 33081, Italy
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Bologna, 40138, Italy
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Catania, 95126, Italy
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Florence, 50134, Italy
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Haifa, 34362, Italy
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Milan, 20132, Italy
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Milan, 20141, Italy
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Milan, 20159, Italy
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Milan, 20162, Italy
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Milan, 35128, Italy
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Monza, 20900, Italy
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Naples, 80131, Italy
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Parma, 43126, Italy
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Pisa, 56100, Italy
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Ponderano, 13875, Italy
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Roma, 00168, Italy
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Torino, 10128, Italy
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Vicenza, 36100, Italy
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Chūōku, 104-0045, Japan
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Hidaka-shi, 350-1298, Japan
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Isehara-shi, 259-1193, Japan
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Kashiwa-shi, 277-8567, Japan
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Kōtoku, 135-8550, Japan
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Kurume-shi, 830-0011, Japan
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Matsuyama, 791-0280, Japan
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Minatoku, 105-8471, Japan
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Nagoya, 464-8681, Japan
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Nakagami-gun, 903-0215, Japan
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Niigata, 951-8510, Japan
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Okayama, 700-8558, Japan
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Osaka, 637086, Japan
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Sapporo, 003-0804, Japan
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Sapporo, 060-8638, Japan
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Sendai, 980-8574, Japan
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Suita, 565-0871, Japan
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Sunto-gun, 411-8777, Japan
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Toon-Shi, 791-0295, Japan
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Tsu, 514-8507, Japan
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Yokohama, 236-0004, Japan
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Kaunas, LT50009, Lithuania
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Vilnius, 08661, Lithuania
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Vilnius, 8660, Lithuania
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Amsterdam, 1081 HV, Netherlands
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Maastricht, 6202 AZ, Netherlands
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Lodz, 93-338, Poland
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Siedlce, 08-110, Poland
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Singapore, 119082, Singapore
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Singapore, 217562, Singapore
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Ljubljana, 1000, Slovenia
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Maribor, 2000, Slovenia
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Goyang-si, 410-769, South Korea
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Gwangjin-gu, 110-744, South Korea
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Seoul, 03722, South Korea
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Seoul, 06273, South Korea
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Seoul, 135-710, South Korea
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Songpa-gu, 05505, South Korea
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Suwon, 16499, South Korea
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Badalona, 8916, Spain
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Barcelona, 8025, Spain
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Barcelona, 8035, Spain
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Córdoba, 14004, Spain
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El Palmar (Murcia), 30120, Spain
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Hospitalet DEL Llobregat, 8908, Spain
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Madrid, 28033, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Oviedo, 33011, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41013, Spain
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Seville, 41014, Spain
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Valencia, 46010, Spain
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New Taipei City, 220, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 100, Taiwan
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Taipei, 10449, Taiwan
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Bebington, CH63 4JY, United Kingdom
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Canterbury, CT1 3NG, United Kingdom
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Derby, DE22 3NE, United Kingdom
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London, E1 1BB, United Kingdom
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London, W2 1NY, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Northwood, HA6 2RN, United Kingdom
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Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Slomovitz, MD
Icahn School of Medicine at Mount Sinai
- PRINCIPAL INVESTIGATOR
Stephanie Gaillard, MD, PhD
Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center (SKCCC)
- PRINCIPAL INVESTIGATOR
Nicole Concin, Prof.
Head of the Division of General Gynecology and Gynecologic Oncology at the Department of Obstetrics and Gynecology of MedUni Vienna and University
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Open label
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2025
First Posted
June 30, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
January 20, 2028
Study Completion (Estimated)
July 17, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.