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RecruitingLast updated: 23 June 2026

TREVI-OC-01: Assessing a new treatment called AZD5335 compared to standard treatment for people with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal 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)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Female Reproductive System Cancers Gynaecological

Age

People18+

Trial acronym

TREVI-OC-01

Clinical summary

Summary

This study is comparing a new treatment called AZD5335 with current standard treatments to see which works better for people with advanced ovarian, fallopian tube, or related cancers that no longer respond well to platinum-based chemotherapy.

Participants will be grouped based on the level of a protein called FRα in their cancer, and then randomly assigned (by chance) to receive either AZD5335 or the usual treatment for their group.

Researchers will regularly check how the cancer is responding to treatment and will continue to follow participants to see how long they live and how well the treatment works over time. An independent group of experts will also review safety throughout the study to help ensure participants' wellbeing.

Conditions

This trial is treating people with high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer that is platinum-resistant

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

AstraZeneca

Scientific Title

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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