AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer (TREVI-OC-01)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

29 Apr 2026 → ongoing

Decision date (initial)

2026-03-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2025-520466-22-00

ClinicalTrials.gov

NCT07218809

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Pharmacokinetic

For the high FRα Cohort: To determine the efficacy of AZD5335 as compared to Mirvetuximab Soravtansine (MIRV) in participants with Platinum-resistant relapsed ovarian cancer (PRR OC) whose tumours have FRα-high expression by assessment of progression-free survival (PFS).
For the low FRα Cohort: To determine the efficacy of AZD5335 as compared to Investigator’s choice chemotherapy in participants with PRR OC whose tumours have FRα-low expression by assessment of PFS.

Secondary objectives 2

1. For the high FRα Cohort: To determine the efficacy of AZD5335 as compared to MIRV in participants with PRR OC whose tumours have FRα-high expression by assessment of overall surviva
2. For the low FRα Cohort: To determine the efficacy of AZD5335 as compared to Investigator’s choice chemotherapy in participants with PRR OC whose tumours have FRα-low expression by assessment of overall survival

Conditions and MedDRA coding

Advanced Platinum-resistant Epithelial Ovarian Cancer

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Participants with confirmed diagnosis of high-grade serous EOC, primaryperitoneal cancer, or fallopian tube cancer.
2. 2. Participants must have platinum-resistant disease: a) 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. b) 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.
3. 3. Participants must have radiologically progressed on or after their most recent line of therapy.
4. 4. 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
5. 5. 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
6. 6. Provision of an FFPE tumour tissue sample

Exclusion criteria 7

1. 1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology,mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.
2. 2. 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-containingchemotherapy.
3. 3. Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring
4. 4. Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease.
5. 5. 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.
6. 6. Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC.
7. 7. Major surgical procedure within 4 weeks of the first dose of study intervention

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression free Survival (PFS): PFS is defined as the time from randomization to radiographic progression as assessed by the Investigator per RECIST v1.1, or death due to any cause.

Secondary endpoints 1

1. Overall survival (OS): OS is defined as the time from randomisation until the date of death due to any cause.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Third parties 2

Locations

10 EU/EEA countries · 81 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 78 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications