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RECRUITINGPhase 3INTERVENTIONAL

AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Key Inclusion 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 Key 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Key Inclusion 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 Key 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

Treatments Being Tested

DRUG

AZD5335

antibody drug conjugate

DRUG

Mirvetuximab Soravtansine (MIRV)

antibody drug conjugate

DRUG

Paclitaxel

chemotherapy

DRUG

Pegylated liposomal Doxorubicin (PLD)

chemotherapy

DRUG

Topotecan

chemotherapy

Locations (20)

Research Site
Fort Lauderdale, Florida, United States
Research Site
Jupiter, Florida, United States
Research Site
Evanston, Illinois, United States
Research Site
Peoria, Illinois, United States
Research Site
Urbana, Illinois, United States
Research Site
Towson, Maryland, United States
Research Site
Burlington, Massachusetts, United States
Research Site
Worcester, Massachusetts, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Omaha, Nebraska, United States
Research Site
Las Vegas, Nevada, United States
Research Site
The Bronx, New York, United States
Research Site
Dayton, Ohio, United States
Research Site
Sylvania, Ohio, United States
Research Site
San Antonio, Texas, United States
Research Site
Tyler, Texas, United States
Research Site
Fairfax, Virginia, United States
Research Site
Adelaide, Australia
Research Site
Auchenflower, Australia
Research Site
Box Hill, Australia