A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations with Intravenous Mirvetuximab Soravtansine in Adult Participants with Ovarian Cancer

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Jan 2026 → ongoing

Decision date (initial)

2026-01-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2025-521606-18-00

ClinicalTrials.gov

NCT07059845

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety

- To evaluate the safety, tolerability, and efficacy of MIRV in combination regimens in FRα positive ovarian cancer participants
- To optimize the MIRV dose in combination regimens to determine the recommended Phase 3 dose (RP3D) in applicable substudies

Secondary objectives 1

1. To evaluate the pharmacokinetics (PK) and immunogenicity of MIRV in combination regimens in FRα positive ovarian cancer participants.

Conditions and MedDRA coding

Ovarian Cancer

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Substudy 1 and 2: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
2. Substudy 1: Participants must have a confirmed diagnosis of FIGO Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
3. Substudy 1: Tumor must be confirmed HRD test negative (HRP), determined by a local HRD test.
4. Substudy 2: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
5. Substudy 2: Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
6. Substudy 2: Participants must have platinum-sensitive disease defined as radiographic progression greater than 6 months from the last dose of platinum-based chemotherapy.
7. Substudy 2: Participants must have measurable disease per RECIST v1.1 (assessed by the investigator) at baseline.

Exclusion criteria 4

1. Substudy 1: Participants with PD while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.
2. Substudy 1: Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.
3. Substudy 2: More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations: • Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens. • Maintenance therapy (e.g., bevacizumab, PARP inhibitor) will be considered part of the preceding line of therapy (i.e., not counted independently). • If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the proceeding line of therapy • Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)
4. Substudy 1 and 2: Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

1. Substudy 1 and 2: Number of Participants with TEAEs (any grade, Grade ≥ 3)
2. Substudy 1 and 2: Number of Participants with TEAEs leading to discontinuation
3. Substudy 1 and 2: Number of Participants with Ocular AEs (any grade, Grade ≥ 2)
4. Substudy 1 and 2: Overall Response (OR) as assessed by the investigator per RECIST v1.1
5. Substudy 1: Progression free survival (PFS) as assessed by the investigator per RECIST v1.1

Secondary endpoints 5

1. Substudy 1 and 2: CA-125 response per Gynecologic Cancer Intergroup (GCIG) Criteria
2. Substudy 1 and 2: Duration of Response (DOR) as assessed by the investigator per RECIST v1.1
3. Substudy 1 and 2: Number of Participants with Peripheral neuropathy AEs (any grade, Grade ≥ 2)
4. Substudy 1 and 2: Number of Participants with Pneumonitis/ Interstitial Lung Disease (ILD) (any grade)
5. Substudy 2: PFS as assessed by the investigator per RECIST v1.1

Investigational products

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

Test 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 5

Locations

5 EU/EEA countries · 38 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 68 files

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

Application history

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