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RECRUITINGPhase 2INTERVENTIONAL

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

A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Mirvetuximab Soravtansine

Intravenous (IV) infusion

DRUG

Bevacizumab

IV Infusion

DRUG

Carboplatin

IV Infusion

Locations (10)

St. George Private Hospital /ID# 276570
Kogarah, New South Wales, Australia
Icon Cancer Centre Wesley /ID# 277199
Auchenflower, Queensland, Australia
Burnside War Memorial Hospital /ID# 277602
Adelaide, South Australia, Australia
Icon Cancer Centre Hobart /ID# 277688
Hobart, Tasmania, Australia
Monash Health - Monash Medical Centre /ID# 276984
Clayton, Victoria, Australia
Austin Hospital /ID# 276534
Melbourne, Victoria, Australia
Seoul National University Hospital /ID# 276182
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 276266
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 276261
Seoul, Seoul Teugbyeolsi, South Korea
Korea University Guro Hospital /ID# 276194
Seoul, Seoul Teugbyeolsi, South Korea