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

Not Applicable

Not yet recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab; Drug: Carboplatin

• Registration Number: NCT07059845
• Lead Sponsor: AbbVie

Brief Summary

Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.

Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 2 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. Approximately 320 participants will be enrolled in the study at 100 sites around the world.

Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-09-08
• Primary Completion: 2029-01
• Study Completion: 2029-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• Substudy 1 and 2: Confirmed high or medium folate receptor alpha (FRa) expression by Ventana folate receptor 1 (FOLR1) Assay.
• Substudy 1 and 2: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
• Substudy 1: Participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
• Substudy 1: Tumor must be confirmed HRD test negative (HRP), determined by a local homologous recombination deficient (HRD) test.
• Substudy 2: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
• Substudy 2: Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.
• Substudy 2: Participants must have platinum-sensitive disease defined as radiographic progression greater than 6 months from the last dose of platinum-based chemotherapy.
• Substudy 2: Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.

Exclusion Criteria

• Substudy 1: Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.
• Substudy 1: Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.
• Substudy 1: Participants who received prior treatment with mirvetuximab soravtansine, any FRα-targeting agent, or any investigational agent.
• 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)
• Substudy 2: Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A	Mirvetuximab Soravtansine	Participants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration.
Substudy 2 Arm E: MIRV Dose B	Mirvetuximab Soravtansine	Participants will receive dose B of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.
Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A	Bevacizumab	Participants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration.
Substudy 1 Arm C: Bev	Bevacizumab	Participants will receive Bev, as part of the approximately 40 month study duration.
Substudy 2 Arm D: MIRV Dose A	Mirvetuximab Soravtansine	Participants will receive dose A of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.
Substudy 2 Arm D: MIRV Dose A	Carboplatin	Participants will receive dose A of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.
Substudy 2 Arm E: MIRV Dose B	Carboplatin	Participants will receive dose B of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.
Substudy 1 Arm B: MIRV Dose B	Mirvetuximab Soravtansine	Participants will receive dose B of MIRV with Bev, as part of the approximately 40 month study duration.
Substudy 1 Arm B: MIRV Dose B	Bevacizumab	Participants will receive dose B of MIRV with Bev, as part of the approximately 40 month study duration.

Primary Outcome Measures

Name	Time	Method
Substudy 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3)	Up to Approximately 40 Months	TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
Substudy 1 and 2: Number of Participants with TEAEs Leading to Discontinuation	Up to Approximately 40 Months	TEAEs defined as any adverse event (AE) with the onset after the first dose of study drug until 30 days after the last dose of the study drug.
Substudy 1 and 2: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2)	Up to Approximately 40 Months	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Substudy 1 and 2: Overall Response (OR) as Assessed by the Investigator per RECIST v1.1	Up to Approximately 40 Months	OR is defined as achieving a best overall response of confirmed complete response (CR) or confirmed partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Substudy 1: Progression free survival (PFS) as Assessed by the Investigator per RECIST v1.1	Up to Approximately 40 Months	PFS is defined as the time from the date of randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Substudy 1 and 2: CA-125 Response per Gynecologic Cancer Intergroup (GCIG) Criteria	Up to Approximately 40 Months	CA-125 response per GCIG Criteria.
Substudy 1 and 2: Duration of Response (DOR) as Assessed by the Investigator per RECIST v1.1	Up to Approximately 40 Months	DoR is defined for confirmed responders as the time from the participants' initial response (CR or PR) to the first occurrence of radiographic progression per RECIST v1.1 or death from any cause.
Substudy 1 and 2: Number of Participants with Peripheral Neuropathy AEs (any grade, Grade ≥ 2)	Up to Approximately 40 Months	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Substudy 1 and 2: Number of Participants with Pneumonitis/ Interstitial Lung Disease (ILD) (any grade)	Up to Approximately 40 Months	ILD is defined by ILD standardized MedDRA query (SMQ) (broad) per investigator and determined per adjudication.
Substudy 2: PFS as Assessed by the Investigator per RECIST v1.1	Up to Approximately 40 Months	PFS is defined as the time from the date of randomization to the first occurrence of radiographic progression based on RECIST version 1.1 or death from any cause, whichever occurs first.