Clinical Trials List
2025-11-01 - 2030-05-18
Phase III
Recruiting8
ICD-10D39.10
Neoplasm of uncertain behavior of unspecified ovary
ICD-10D39.11
Neoplasm of uncertain behavior of right ovary
ICD-10D39.12
Neoplasm of uncertain behavior of left ovary
ICD-9236.2
Neoplasm of uncertain behavior of ovary
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)
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/04/09
Investigators and Locations
Co-Principal Investigator
- 張文君 無
- - - 無
- 林昭文 無
- BOR-CHING SHEU 無
- YING-CHENG CHIANG 無
- 陳宇立 無
- 戴依柔 無
- 吳佳穎 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Intravenous infusion solution
Infusion solution
Infusion solution
Concentrated powder
Infusion solution
Active Ingredient
Protectant Solution for infusion
Mirvetuximab Soravtansine
Paclitaxel
Topotecan
Pegylated Liposomal Doxorubicin
Dosage Form
27C
27C
149
27C
Dosage
1 mL IV Bag
5 mg/mL
6 mg/mL
4 mg/vial
2 mg/mL
Endpoints
The efficacy of AZD5335 versus MIRV in PRR OC participants with FRα high expression tumors was determined by assessing PFS.
FRα Low Expression Group
The efficacy of AZD5335 versus IC chemotherapy in PRR OC participants with FRα low expression tumors was determined by assessing PFS.
Inclution Criteria
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
Exclusion Criteria
Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.
Primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤ 3 months after the last dose of first line platinum-containing chemotherapy.
Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring
Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease.
Participant has non-infectious ILD/pneumonitis or has a history of non-infectious ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC.
Major surgical procedure within 4 weeks of the first dose of study intervention
The Estimated Number of Participants
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Taiwan
41 participants
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Global
1100 participants
