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

NCT07059845 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: M25-7092025-521606-18
• Study Type: interventional
• Target: 320
• Locations: 2 countries
• Sites: 10

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.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Mirvetuximab Soravtansine; Bevacizumab; Carboplatin

Outcome Measures

Primary Outcomes (5)

• Substudy 1 and 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3)

  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.

  Up to Approximately 40 Months

• Substudy 1 and 2: Number of Participants with TEAEs Leading to Discontinuation

  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.

  Up to Approximately 40 Months

• Substudy 1 and 2: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2)

  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.

  Up to Approximately 40 Months

• Substudy 1 and 2: Overall Response (OR) as Assessed by the Investigator per RECIST v1.1

  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.

  Up to Approximately 40 Months

• Substudy 1: Progression free survival (PFS) as Assessed by the Investigator per RECIST v1.1

  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.

  Up to Approximately 40 Months

Secondary Outcomes (5)

• Substudy 1 and 2: CA-125 Response per Gynecologic Cancer Intergroup (GCIG) Criteria

  Up to Approximately 40 Months

• Substudy 1 and 2: Duration of Response (DOR) as Assessed by the Investigator per RECIST v1.1

  Up to Approximately 40 Months

• Substudy 1 and 2: Number of Participants with Peripheral Neuropathy AEs (any grade, Grade ≥ 2)

  Up to Approximately 40 Months

• Substudy 1 and 2: Number of Participants with Pneumonitis/ Interstitial Lung Disease (ILD) (any grade)

  Up to Approximately 40 Months

• Substudy 2: PFS as Assessed by the Investigator per RECIST v1.1

  Up to Approximately 40 Months

Study Arms (5)

Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A

EXPERIMENTAL

Participants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration.

Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab

Substudy 1 Arm B: MIRV Dose B

EXPERIMENTAL

Participants will receive dose B of MIRV with Bev, as part of the approximately 40 month study duration.

Drug: Mirvetuximab Soravtansine; Drug: Bevacizumab

Substudy 1 Arm C: Bev

EXPERIMENTAL

Participants will receive Bev, as part of the approximately 40 month study duration.

Drug: Bevacizumab

Substudy 2 Arm D: MIRV Dose A

EXPERIMENTAL

Participants will receive dose A of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.

Drug: Mirvetuximab Soravtansine; Drug: Carboplatin

Substudy 2 Arm E: MIRV Dose B

EXPERIMENTAL

Participants will receive dose B of MIRV with carboplatin, followed by MIRV alone, as part of the approximately 31 month study duration.

Drug: Mirvetuximab Soravtansine; Drug: Carboplatin

Interventions

Mirvetuximab Soravtansine DRUG

Intravenous (IV) infusion

Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A; Substudy 1 Arm B: MIRV Dose B; Substudy 2 Arm D: MIRV Dose A; Substudy 2 Arm E: MIRV Dose B

Bevacizumab DRUG

IV Infusion

Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A; Substudy 1 Arm B: MIRV Dose B; Substudy 1 Arm C: Bev

Carboplatin DRUG

IV Infusion

Substudy 2 Arm D: MIRV Dose A; Substudy 2 Arm E: MIRV Dose B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (10)

St. George Private Hospital /ID# 276570

Kogarah, New South Wales, 2217, Australia

RECRUITING

Icon Cancer Centre Wesley /ID# 277199

Auchenflower, Queensland, 4066, Australia

RECRUITING

Burnside War Memorial Hospital /ID# 277602

Adelaide, South Australia, 5065, Australia

RECRUITING

Icon Cancer Centre Hobart /ID# 277688

Hobart, Tasmania, 7000, Australia

RECRUITING

Monash Health - Monash Medical Centre /ID# 276984

Clayton, Victoria, 3168, Australia

RECRUITING

Austin Hospital /ID# 276534

Melbourne, Victoria, 3084, Australia

RECRUITING

Seoul National University Hospital /ID# 276182

Seoul, Seoul Teugbyeolsi, 03080, South Korea

RECRUITING

Yonsei University Health System Severance Hospital /ID# 276266

Seoul, Seoul Teugbyeolsi, 03722, South Korea

RECRUITING

Samsung Medical Center /ID# 276261

Seoul, Seoul Teugbyeolsi, 06351, South Korea

RECRUITING

Korea University Guro Hospital /ID# 276194

Seoul, Seoul Teugbyeolsi, 08308, South Korea

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

mirvetuximab soravtansine; Bevacizumab; Carboplatin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

KR (4); AU (6)