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A Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator's Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)

Status: Recruiting
Location: See all (121) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer.

• Participants must have platinum-resistant disease:

• Participants who have only had one prior line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between \> 3 months and ≤ 6 months after the date of the last dose of platinum.

• Participants who have received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of the last dose of platinum.

• Participants must have radiologically progressed on or after their most recent line of therapy.

• Participants must have received at least one, but no more than 3, prior systemic lines of anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment

• Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication, precaution or intolerance.

• Provision of an FFPE tumour tissue sample

Locations
United States
Florida
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Fort Lauderdale
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Jupiter
Illinois
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Evanston
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Peoria
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Urbana
Massachusetts
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Burlington
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Worcester
Maryland
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Towson
Minnesota
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Minneapolis
Nebraska
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Omaha
Nevada
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Las Vegas
New York
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The Bronx
Ohio
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Dayton
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Sylvania
Texas
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San Antonio
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Tyler
Virginia
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Fairfax
Other Locations
Australia
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Adelaide
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Auchenflower
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Box Hill
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Campbelltown
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Clayton
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Melbourne
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St Leonards
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Waratah Nsw
Belgium
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Charleroi
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Ghent
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Leuven
Brazil
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Porto Alegre
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São José Do Rio Preto
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São Paulo
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São Paulo
Canada
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Edmonton
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Hamilton
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Kingston
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Montreal
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Montreal
Chile
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Port Montt
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Santiago
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Santiago
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Santiago
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Santiago
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Santiago
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Viña Del Mar
China
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Beijing
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Bengbu
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Changchun
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Changsha
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Changsha
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Chongqing
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Guangzhou
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Guangzhou
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Hangzhou
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Hangzhou
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Hangzhou
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Jinan
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Jinan
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Nanchang
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Nanjing
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Nanjing
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Nanning
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Shenyang
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Shenyang
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Shijiazhuang
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Tianjin
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Wuhan
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Wuhan
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Xi'an
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Zhengzhou
Denmark
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Aarhus
France
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Amiens
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Avignon
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Paris
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Pau
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Saint-herblain
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Saint-priest-en-jarez
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Tours
Germany
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Bonn
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Dresden
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Schwäbisch Hall
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Tübingen
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Wiesbaden
Greece
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Athens
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Athens
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Pátrai
India
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Bhubaneswar
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Delhi
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Dhanvantari Nagar
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Kolkata
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Nagpur
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Nashik
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Surat
Ireland
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Cork
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Dublin
Israel
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Hadera
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Haifa
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Jerusalem
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Jerusalem
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Kfar Saba
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Ramat Gan
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Tel Aviv
Italy
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Brescia
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Catania
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Florence
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Lecco
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Milan
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Milan
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Milan
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Milan
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Parma
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Pisa
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Roma
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Roma
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Torino
Japan
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Sendai
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Sunto-gun
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Tsu
Spain
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A Coruña
Sweden
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Uppsala
Taiwan
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Tainan
United Kingdom
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London
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-12-29
Estimated Completion Date: 2030-05-27
Participants
Target number of participants: 1100
Treatments
Experimental: AZD5335 in FRa-high cohort
AZD5335 IV (intravenous) in FRa-high cohort
Active_comparator: Mirvetuximab Soravtansine (MIRV) in FRa-high cohort
MIRV AIBW IV in FRa-high cohort
Experimental: AZD5335 in FRa-low cohort
AZD5335 IV (intravenous) in FRa-low cohort
Active_comparator: Investigator´s choice chemotherapy in FRa-low cohort
Investigator's choice of chemotherapy Paclitaxel IV Pegylated liposomal Doxorubicin (PLD) IV or Topotecan IV in FRa-low cohor
Related Therapeutic Areas
Sponsors
Collaborators: European Network of Gynecological Oncological Trial Groups (ENGOT), GOG Foundation, Inc. (GOG Foundation), Ventana Medical Systems, Inc
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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