TREVI-OC-01

• Research type

  Research Study

• Full 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)

• IRAS ID

  1013010

• Contact name

  AstraZeneca Clinical Study Information Center

• Contact email

  information.center@astrazeneca.com

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2025-520466-22

• Clinicaltrials.gov Identifier

  NCT07218809

• Research summary

  Researchers are looking for a better way to treat platinum-resistant ovarian cancer. Common treatments include chemotherapy and immunotherapy drugs designed to help the immune cells stop tumours from growing, but these do not always work well and better treatments are required when these fail.

  This trial is aiming to see whether a new drug AZD53355, may work better than more standard chemotherapy. AZD5335 is a type of cancer treatment called an antibody-drug conjugate (ADC). It is designed to target a protein on the surface of cancer cells called folate receptor alpha (FRα). AZD5335 may shrink or control tumours in patients whose cancer cells contain FRα.

  There will be two cohorts:
  FRα-high cohort: AZD5335 compared to MIRV.
  FRα-low cohort: AZD5335 compared to paclitaxel, PLD or topotecan.

  This study includes 4 periods:
  Screening 1 (a sample of the participant’s cancer tissue is tested to determine if they have an FRα positive tumour)
  Screening 2 (to check that they are eligible)
  Treatment
  Follow-up

  Participants who receive treatment will be allocated to either the FRα-high or FRα-low cohort. They will then be randomly assigned to either AZD5335 or a comparator drug (MIRV for FRα-high cohort, or a standard chemotherapy for FRα-low cohort).

  AZD5335 or MIRV are given as an IV infusion once every 3 weeks and standard chemotherapies (Paclitaxel 4 days every 4 weeks, PLD 1 day every 4 weeks, Topotecan 3 days every 4 weeks or Topotecan every day for 5 days every 4 weeks)

  The total number of cycles of treatment given and how long participants will be in the study will depend on when their cancer has worsened.

  The total study size will be approximately 1100 participants

• REC name

  West of Scotland REC 1

• REC reference

  25/WS/0189

• Date of REC Opinion

  29 Jan 2026

• REC opinion

  Further Information Favourable Opinion