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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
Burnside War Memorial Hospital /ID# 277602
RECRUITING
Adelaide
Icon Cancer Centre Wesley /ID# 277199
RECRUITING
Auchenflower
Monash Health - Monash Medical Centre /ID# 276984
RECRUITING
Clayton
Icon Cancer Centre Hobart /ID# 277688
RECRUITING
Hobart
St. George Private Hospital /ID# 276570
RECRUITING
Kogarah
Austin Hospital /ID# 276534
RECRUITING
Melbourne
Republic of Korea
Korea University Guro Hospital /ID# 276194
RECRUITING
Seoul
Samsung Medical Center /ID# 276261
RECRUITING
Seoul
Seoul National University Hospital /ID# 276182
RECRUITING
Seoul
Yonsei University Health System Severance Hospital /ID# 276266
RECRUITING
Seoul
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-11-13
Estimated Completion Date: 2029-01
Participants
Target number of participants: 320
Treatments
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.
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.
Experimental: Substudy 1 Arm C: Bev
Participants will receive Bev, as part of the approximately 40 month study duration.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

Similar Clinical Trials