Home/Get Matched/NCT07218809
PHASE3RECRUITING
View on ClinicalTrials.gov

Comparing 4 approaches for epithelial ovarian cancer

Official title: 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)

Condition: Epithelial Ovarian CancerSponsor: AstraZenecaTarget enrollment: 1100

Interventions

DRUG

AZD5335

antibody drug conjugate

DRUG

Mirvetuximab Soravtansine (MIRV)

antibody drug conjugate

DRUG

Paclitaxel

chemotherapy

DRUG

Pegylated liposomal Doxorubicin (PLD)

chemotherapy

DRUG

Topotecan

chemotherapy

Canadian Sites (7)

Research Site

Québec, Canada

NOT_YET_RECRUITING

Research Site

Edmonton, Alberta, Canada

NOT_YET_RECRUITING

Research Site

Hamilton, Ontario, Canada

NOT_YET_RECRUITING

Research Site

Kingston, Ontario, Canada

NOT_YET_RECRUITING

Research Site

Montreal, Quebec, Canada

NOT_YET_RECRUITING

Research Site

Montreal, Quebec, Canada

NOT_YET_RECRUITING

Research Site

Montreal, Quebec, Canada

NOT_YET_RECRUITING

Eligibility Criteria

See who this study is looking for23 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

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
  • +Key Exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
  • +Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.
  • +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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
  • +Major surgical procedure within 4 weeks of the first dose of study intervention
  • +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.
  • +Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC.

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.
  • 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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
  • Major surgical procedure within 4 weeks of the first dose of study intervention
  • 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.
  • Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC.
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.

What is being given or done in this study: AZD5335, Mirvetuximab Soravtansine (MIRV), Paclitaxel, Pegylated liposomal Doxorubicin (PLD), and 1 more.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
  • armsInterventionsModule.interventions[].name
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

One group of people involved — usually the participants — is not told which treatment is which.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

There are 4 groups in this study.

From the trial registry

Built from this field:

  • armsInterventionsModule.armGroups[].type
Who the study is looking for

The study lists a minimum age of 18 years, with no upper limit given.

The study lists female participants only.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 1,100 people.

The study is currently expected to finish around December 2029.

The main measurement is taken over: Up to approximately 5 years.

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Progression free Survival (PFS) — measured over Up to approximately 5 years.

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07218809 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About AZD5335Drug

antibody drug conjugate

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Mirvetuximab Soravtansine (MIRV)Drug

antibody drug conjugate

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About PaclitaxelDrug

chemotherapy

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About Pegylated liposomal Doxorubicin (PLD)Drug

chemotherapy

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

About TopotecanDrug

chemotherapy

From the trial registry — its own words, unedited.

What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 18 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

One group of people involved — usually the participants — is not told which treatment is which.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 18 years, with no upper limit given.

It lists female participants only.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: Up to approximately 5 years.

The study as a whole is currently expected to finish around 2029-12-27.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 1,100 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists 9 locations, including: Québec, Canada; Edmonton, Alberta, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; Montreal, Quebec, Canada; Minneapolis, Minnesota, United States, and 3 more.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

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.

Other Sites (4)

Research Site

Minneapolis, Minnesota, United States

Research Site

Billings, Montana, United States

Research Site

The Bronx, New York, United States

Research Site

Seattle, Washington, United States

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.