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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
EU CTIS ID: 2025-521606-18-00
What this study is testing
- To evaluate the safety, tolerability, and efficacy of MIRV in combination regimens in FRα positive ovarian cancer participants - To optimize the MIRV dose in combination regimens to determine the recommended Phase 3 dose (RP3D) in applicable substudies
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Substudy 1 and 2 and: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Substudy 1: Participants must have completed one (1L subjects) or two (2L subjects) platinum-based triplet chemotherapy regimens: a. For 1L participants, the triplet regimen must be composed of carboplatin, paclitaxel, and bevacizumab. b. For 2L participants, the last triplet must be composed of carboplatin, bevacizumab and either paclitaxel, gemcitabine, or PLD. c. In addition, for both 1L and 2L participants, the last triplet regimen should include at least 4 cycles of platinum-based triplet therapy (maximum 8 cycles) and include at least 2 cycles of bevacizumab.
- Substudy 2 and 3: Prior local BRCA test results are required for eligibility. Subjects with a germline or tumor BRCA mutation must have received prior treatment with a PARPi unless documented as clinically contraindicated.
- Substudy 1: Participants must have a confirmed diagnosis of 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 HRD test.Subject has a local HRD or BRCA test result available. Subjects with BRCA wild-type will need to have a local HRD test result available.
- Substudy 2 and 3: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
You likely can't join if
- Substudy 1: Participants with 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. Note: The Day 15 dose of bevacizumab in the last cycle of triplet therapy including PLD in 2L subjects is not considered an intervening dose.
- Substudy 2 and 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, 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 1 and 2: Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents, or a PARPI.
- Substudy 1: Subjects who are to receive a PARPi as maintenance treatment, according to SOC and investigator discretion, are excluded. Reasons for which the subject is not considered eligible for PARPi will be recorded as follows: • HRD negative • HRD positive with SD as best response after last platinum-based triplet regimen • HRD tested, but inconclusive • HRD positive but safety concern (safety concern to be specified)
See the full eligibility criteria
Who can join
- Substudy 1 and 2 and: Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.
- Substudy 1: Participants must have completed one (1L subjects) or two (2L subjects) platinum-based triplet chemotherapy regimens: a. For 1L participants, the triplet regimen must be composed of carboplatin, paclitaxel, and bevacizumab. b. For 2L participants, the last triplet must be composed of carboplatin, bevacizumab and either paclitaxel, gemcitabine, or PLD. c. In addition, for both 1L and 2L participants, the last triplet regimen should include at least 4 cycles of platinum-based triplet therapy (maximum 8 cycles) and include at least 2 cycles of bevacizumab.
- Substudy 2 and 3: Prior local BRCA test results are required for eligibility. Subjects with a germline or tumor BRCA mutation must have received prior treatment with a PARPi unless documented as clinically contraindicated.
- Substudy 1: Participants must have a confirmed diagnosis of 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 HRD test.Subject has a local HRD or BRCA test result available. Subjects with BRCA wild-type will need to have a local HRD test result available.
- Substudy 2 and 3: Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- Substudy 2 and 3: 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 183 days from the last dose of platinum-based chemotherapy.
- Substudy 2 and 3: Participants must have measurable disease per RECIST v1.1 (assessed by the investigator) at baseline.
- Substuy 1,2 and 3:Subjects 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 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.
- Substudy 1: 2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
What rules you out
- Substudy 1: Participants with 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. Note: The Day 15 dose of bevacizumab in the last cycle of triplet therapy including PLD in 2L subjects is not considered an intervening dose.
- Substudy 2 and 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, 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 1 and 2: Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents, or a PARPI.
- Substudy 1: Subjects who are to receive a PARPi as maintenance treatment, according to SOC and investigator discretion, are excluded. Reasons for which the subject is not considered eligible for PARPi will be recorded as follows: • HRD negative • HRD positive with SD as best response after last platinum-based triplet regimen • HRD tested, but inconclusive • HRD positive but safety concern (safety concern to be specified)
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Australia
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Australia; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.