Purpose

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 3 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. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 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 carboplatin and 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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

Substudy 1 - Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in >= 50% of viable tumor cells with >= 2+ staining intensity. - Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. - 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. 2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression. - Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available. Substudy 2 - Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in >= 50% of viable tumor cells with >= 2+ staining intensity. - Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. - Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. - Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy. - Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy. - Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline. Substudy 3 - Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in >= 50% of viable tumor cells with >= 2+ staining intensity. - Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1. - Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer. - Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy. - Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy. - 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. - Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization. - Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi). 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, PARPi) 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 same 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) - Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents. Substudy 3 - 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, PARPi) 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 same 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) - Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Substudy 1 Arm A: Mirvetuximab Soravtansine (MIRV) Dose A
Participants will receive dose A of MIRV with bevacizumab (Bev), as part of the approximately 40 month study duration.
  • Drug: Mirvetuximab Soravtansine
    Intravenous (IV) infusion
  • Drug: Bevacizumab
    IV Infusion
Experimental
Substudy 1 Arm B: MIRV Dose B
Participants will receive dose B of MIRV with Bev, as part of the approximately 40 month study duration.
  • Drug: Mirvetuximab Soravtansine
    Intravenous (IV) infusion
  • Drug: Bevacizumab
    IV Infusion
Experimental
Substudy 1 Arm C: Bev
Participants will receive Bev, as part of the approximately 40 month study duration.
  • Drug: Bevacizumab
    IV Infusion
Experimental
Substudy 2 Arm D: MIRV Dose A
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
    Intravenous (IV) infusion
  • Drug: Carboplatin
    IV Infusion
Experimental
Substudy 2 Arm E: MIRV Dose B
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
    Intravenous (IV) infusion
  • Drug: Carboplatin
    IV Infusion
Experimental
Substudy 3 Arm F: MIRV Dose A
Participants will receive dose A of MIRV with BEV and carboplatin, followed by MIRV at a lower dose with BEV, as part of the approximately 31 month study duration.
  • Drug: Mirvetuximab Soravtansine
    Intravenous (IV) infusion
  • Drug: Bevacizumab
    IV Infusion
  • Drug: Carboplatin
    IV Infusion
Experimental
Substudy 3 Arm G: MIRV Dose B
Participants will receive dose B of MIRV with BEV and carboplatin, followed by MIRV at the same dose with BEV, as part of the approximately 31 month study duration.
  • Drug: Mirvetuximab Soravtansine
    Intravenous (IV) infusion
  • Drug: Bevacizumab
    IV Infusion
  • Drug: Carboplatin
    IV Infusion

Recruiting Locations

UC San Diego Health - Moores Cancer Center /ID# 277574
La Jolla, California 92037

University of Florida College of Medicine /ID# 278348
Gainesville, Florida 32610

Orlando Health Cancer Institute Gynecologic Cancer Center - Orlando /ID# 278623
Orlando, Florida 32806

Florida Cancer Specialists - North /ID# 278626
St. Petersburg, Florida 33705

Florida Cancer Specialists - East /ID# 278605
West Palm Beach, Florida 33401

Our Lady of the Lake Physician Group - Medical Oncology /ID# 277440
Baton Rouge, Louisiana 70817

Maine Medical Center - Scarborough Campus /ID# 277205
Scarborough, Maine 04074

Karmanos Cancer Institute - Detroit /ID# 277085
Detroit, Michigan 48201

Intermountain Health - Intermountain Health West End Clinic /ID# 278470
Billings, Montana 59106

Md Anderson Cancer Center At Cooper /ID# 278390
Camden, New Jersey 08103

SUNY Upstate Medical University - Syracuse /ID# 277245
Syracuse, New York 13210

FirstHealth of the Carolinas- Speciality Center /ID# 278636
Pinehurst, North Carolina 28374

Jamescare Gynecologic Oncology At Mill Run /ID# 277951
Hilliard, Ohio 43026

Willamette Valley Cancer Institute and Research Center /ID# 277714
Eugene, Oregon 97401

Penn Medicine University of Pennsylvania Health System /ID# 277963
Philadelphia, Pennsylvania 19104

Avera Cancer Institute - Sioux Falls /ID# 278627
Sioux Falls, South Dakota 57105

University Of Tennessee Medical Center /ID# 278225
Knoxville, Tennessee 37920

Texas Oncology - Abilene - Antilley Road /ID# 277739
Abilene, Texas 79606

Texas Oncology - Fort Worth Cancer Center /ID# 277989
Fort Worth, Texas 76104

Texas Oncology - San Antonio Medical Center - Research Drive /ID# 277735
San Antonio, Texas 78240

Texas Oncology - The Woodlands /ID# 277926
The Woodlands, Texas 77380

Texas Oncology - Northeast Texas /ID# 277737
Tyler, Texas 75702

Virginia Mason Hospital and Medical Center /ID# 277259
Seattle, Washington 98101

West Virginia University Hospitals /ID# 278965
Morgantown, West Virginia 26506

More Details

Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.