Actively Recruiting
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
Led by AbbVie · Updated on 2025-12-04
320
Participants Needed
10
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed medium or high folate receptor alpha expression by Ventana folate receptor 1 assay for both substudies
- Eastern Cooperative Oncology Group performance status of 0 or 1 for both substudies
- For substudy 1: Confirmed diagnosis of FIGO Stage III or IV high-grade serous ovarian, primary peritoneal, or fallopian tube cancer
- For substudy 1: Tumor must be homologous recombination deficient (HRD) test negative (HRP) by local testing
- For substudy 2: Confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer
- For substudy 2: Relapsed after 1 or 2 prior lines of platinum-based chemotherapy
- For substudy 2: Platinum-sensitive disease with progression more than 6 months after last platinum dose
- For substudy 2: Measurable disease by RECIST v1.1 at baseline
You will not qualify if you...
- For substudy 1: Progressive disease while on triplet therapy or after last triplet therapy cycle and before randomization
- For substudy 1: Received bevacizumab after last triplet therapy cycle and before randomization
- For substudy 1: Prior treatment with mirvetuximab soravtansine, any folate receptor alpha-targeting agent, or investigational agent
- For substudy 2: More than 2 prior lines of chemotherapy
- For substudy 2: Prior treatment with mirvetuximab soravtansine or other folate receptor alpha-targeting agents
AI-Screening
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Trial Site Locations
Total: 10 locations
1
St. George Private Hospital /ID# 276570
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
2
Icon Cancer Centre Wesley /ID# 277199
Auchenflower, Queensland, Australia, 4066
Actively Recruiting
3
Burnside War Memorial Hospital /ID# 277602
Adelaide, South Australia, Australia, 5065
Actively Recruiting
4
Icon Cancer Centre Hobart /ID# 277688
Hobart, Tasmania, Australia, 7000
Actively Recruiting
5
Monash Health - Monash Medical Centre /ID# 276984
Clayton, Victoria, Australia, 3168
Actively Recruiting
6
Austin Hospital /ID# 276534
Melbourne, Victoria, Australia, 3084
Actively Recruiting
7
Seoul National University Hospital /ID# 276182
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
8
Yonsei University Health System Severance Hospital /ID# 276266
Seoul, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
9
Samsung Medical Center /ID# 276261
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
10
Korea University Guro Hospital /ID# 276194
Seoul, Seoul Teugbyeolsi, South Korea, 08308
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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