TriangleNCT04209855 · CITED IN SOURCE DOCUMENTS
A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha (FRα) Expression
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-08-27
This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1
Overall Survival Assessed by the Investigator Using RECIST v1.1
Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
Time to Second Progression-Free Survival (PFS 2)
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: 1. Female participants ≥ 18 years of age 2. Participants must have a confirmed diagnosis of high-grade serious epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer 3. Participants must have platinum-resistant disease: 1. Participants who have only had 1 line of platinum based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between \>3 months and ≤ 6 months after the date of the last dose of platinum 2. Participants who have received 2 or 3 lines of platinum therapy must have progressed on or within 6 months after the date of the last dose of platinum 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. Note: Participants who are platinum-refractory during front-line treatment are excluded 4. Participants must have progressed radiographically on or after their most recent line of therapy 5. Participants must be willing to provide an archival tumor tissue block or slides, or undergo procedure to obtain a new biopsy using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity 6. Participant's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay 7. Participants must have at least one lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (radiologically measured by the Investigator) 8. Participants must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment: 1. Adjuvant ± neoadjuvant considered one line of therapy 2. Maintenance therapy (for example, bevacizumab, poly (ADP-ribose) polymerase \[PARP\] inhibitors) will be considered as part of the preceding line of therapy (that is, not counted independently) 3. Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (that is, not counted independently) 4. Hormonal therapy will be counted as a separate line of therapy unless it was given as maintenance 9. Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 10. Time from prior therapy: 1. Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter) 2. Focal radiation completed at least 2 weeks prior to first dose of study drug 11. Participants must have stabilized or recovered (Grade 1 or baseline) from all prior therapy-related toxicities 12. Major surgery must be completed at least 4 weeks prior to first dose and have recovered or stabilized from the side effects of prior surgery 13. Participants must have adequate hematologic, liver and kidney functions defined as: 1. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/liter (L) (1,500/microliter \[μL\]) without granulocyte colony-stimulating factor (G-CSF) in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 20 days 2. Platelet count ≥ 100 x 10\^9/L (100,000/μL) without platelet transfusion in the prior 10 days 3. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN 6. Serum bilirubin ≤ 1.5 x ULN (participants with documented diagnosis of Gilbert syndrome are eligible if total bilirubin \< 3.0 x ULN 7. Serum albumin ≥ 2 grams (g)/deciliter (dL) 14. Participants or their legally authorized representative must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements 15. Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) while on study drug and for at least 3 months after the last dose of MIRV or at least 6 months after the last dose of paclitaxel, pegylated liposomal doxorubicin, or topotecan 16. WCBP must have a negative pregnancy test within 4 days prior to the first dose of study drug Exclusion Criteria: 1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, or low-grade or borderline ovarian tumor 2. Participants with primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first line platinum-containing chemotherapy 3. Participants with prior wide-field radiotherapy (RT) affecting at least 20% of the bone marrow 4. Participants with \> Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE) v5.0 5. Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision 6. Participants with serious concurrent illness or clinically relevant active infection, including, but not limited to the following: 1. Active hepatitis B or C infection (whether or not on active antiviral therapy) 2. Human immunodeficiency virus (HIV) infection 3. Active cytomegalovirus infection 4. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks before starting study drug Note: Testing at screening is not required for the above infections unless clinically indicated 7. Participants with history of multiple sclerosis or other demyelinating disease and/or Lambert-Eaton syndrome (paraneoplastic syndrome) 8. Participants with clinically significant cardiac disease including, but not limited to, any one of the following: 1. Myocardial infarction ≤ 6 months prior to first dose 2. Unstable angina pectoris 3. Uncontrolled congestive heart failure (New York Heart Association \> class II) 4. Uncontrolled ≥ Grade 3 hypertension (per CTCAE) 5. Uncontrolled cardiac arrhythmias 9. Participants assigned to PLD stratum only: Left ventricular ejection fraction (LVEF) below the institutional limit of normal as measured by echocardiography (ECHO) or multigated acquisition (MUGA) scan 10. Participants with a history of hemorrhagic or ischemic stroke within six months prior to randomization 11. Participants with a history of cirrhotic liver disease (Child-Pugh Class B or C) 12. Participants with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis 13. Participants with required use of folate-containing supplements (for example, folate deficiency) 14. Participants with prior hypersensitivity to monoclonal antibodies 15. Women who are pregnant or lactating 16. Participants with prior treatment with MIRV or other FRα-targeting agents 17. Participants with untreated or symptomatic central nervous system (CNS) metastases 18. Participants with a history of other malignancy within 3 years prior to randomization. Note: does not include tumors with a negligible risk for metastasis or death (for example, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast 19. Prior known hypersensitivity reactions to study drugs and/or any of their excipients 20. People who are detained through a court or administrative decision, receiving psychiatric care against their will, adults who are the subject of a legal protection order (under tutorship/curatorship), people who are unable to express their consent, and people who are subject to a legal guardianship order 21. Simultaneous participation in another research study, in countries or localities where this is the health authority guidance
- gender Based
- true
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- FEMALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive single-agent mirvetuximab soravtansine (MIRV) at 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of every 3-week cycle (Q3W).
- intervention Names
- Drug: Mirvetuximab Soravtansine
- label
- Mirvetuximab Soravtansine
- type
- EXPERIMENTAL
- description
- Participants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel administered at 80 milligrams/square meter (mg/m\^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan administered at 4 mg/m\^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could be administered at 1.25 mg/m\^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin administered at 40 mg/m\^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could be administered as a 1-hour infusion.
- intervention Names
- Drug: Paclitaxel
- Drug: Topotecan
- Drug: Pegylated liposomal doxorubicin
- label
- Investigator's Choice (IC) Chemotherapy
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Mirvetuximab Soravtansine
- description
- Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.
- name
- Mirvetuximab Soravtansine
- other Names
- MIRV
- IMGN853
- type
- DRUG
- arm Group Labels
- Investigator's Choice (IC) Chemotherapy
- description
- Paclitaxel will be administered per dose and schedule specified in the arm.
- name
- Paclitaxel
- type
- DRUG
- arm Group Labels
- Investigator's Choice (IC) Chemotherapy
- description
- Topotecan will be administered per dose and schedule specified in the arm.
- name
- Topotecan
- type
- DRUG
- arm Group Labels
- Investigator's Choice (IC) Chemotherapy
- description
- Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.
- name
- Pegylated liposomal doxorubicin
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 453
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- PFS was defined as the time from randomization until progressive disease (PD) or death whichever occurred first. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 millimeters (mm). Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
- measure
- Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
- time Frame
- From randomization until PD or death, whichever occurred first (up to approximately 36 months)
- secondary Outcomes
- description
- ORR was defined as percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least 30% decrease in the sum of the longest diameters (SoD) of target lesions, taking as reference the baseline SoD.
- measure
- Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1
- time Frame
- Up to approximately 36 months
- description
- Overall survival was defined as the time from the date of first dose until the date of death from any cause, estimated using the Kaplan-Meier method.
- measure
- Overall Survival Assessed by the Investigator Using RECIST v1.1
- time Frame
- Up to approximately 45 months
- description
- The EORTC QLQ-OV28 is specific for ovarian cancer and consists of 28 items assessing abdominal/gastrointestinal symptoms (6 items), peripheral neuropathy (2 items), other chemotherapy side effects (5 items), hormonal symptoms (2 items), body image (2 items), attitudes to disease/treatment (3 items), sexuality (4 items) and 4 other single items. Each scale was scored from 0 to 100 with higher scores on the symptom scales indicating greater symptom burden. Higher scores represent a higher ("better") level of functioning. Presented here are the number of participants achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the EORTC QLQ-OV28.
- measure
- Number of Participants Achieving at Least 15 Point Absolute Improvement in the Abdominal/Gastrointestinal (GI) Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
- time Frame
- Baseline and Week 8 or 9
- description
- An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anticancer treatment, whichever occurred first. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
- measure
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- time Frame
- Up to approximately 37 months
- description
- DOR was defined as the time from the date of the first response (CR or PR), until the date of PD or death from any cause, whichever occurred first. DOR for participants who have not progressed or died at the time of analysis are censored at the date of their last tumor assessment. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also have demonstrated an absolute increase of at least 5 mm. DOR was estimated using the Kaplan-Meier method.
- measure
- Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
- time Frame
- Up to approximately 34 months
- description
- The GCIG CA-125 response was defined as at least 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days.
- measure
- Percentage of Participants With Cancer Antigen 125 (CA-125) Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
- time Frame
- Baseline up to approximately 36 months
- description
- PFS 2 was defined as the time from date of randomization until second disease progression or death whichever occurred first.
- measure
- Time to Second Progression-Free Survival (PFS 2)
- time Frame
- Up to approximately 44 months
Full study description
- brief Summary
- This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine (MIRV) vs. IC chemotherapy in participants with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRα positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.
- detailed Description
- Participants will be randomized to either MIRV or IC chemotherapy (paclitaxel, PEGylated liposomal doxorubicin, or topotecan).
Source references
- references
- citation
- Van Gorp T, Moore KN, Konecny GE, Leary A, Garcia-Garcia Y, Banerjee S, Lorusso D, Lee JY, Moroney JW, Caruso G, Klasa-Mazurkiewicz D, Tromp J, Martin LP, Breuer S, Leath CA 3rd, Cibula D, Weroha SJ, Estevez-Garcia P, O'Malley DM, Miller RE, Coffman L, Scandurra G, Berton D, Li L, Zagadailov E, Diver EJ, Tredan O, Hilpert F. Patient-reported outcomes from the MIRASOL trial evaluating mirvetuximab soravtansine versus chemotherapy in patients with folate receptor alpha-positive, platinum-resistant ovarian cancer: a randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Apr;26(4):503-515. doi: 10.1016/S1470-2045(25)00021-X.
- pmid
- 40179908
- type
- DERIVED
- citation
- Moore KN, Angelergues A, Konecny GE, Garcia Y, Banerjee S, Lorusso D, Lee JY, Moroney JW, Colombo N, Roszak A, Tromp J, Myers T, Lee JW, Beiner M, Cosgrove CM, Cibula D, Martin LP, Sabatier R, Buscema J, Estevez-Garcia P, Coffman L, Nicum S, Duska LR, Pignata S, Galvez F, Wang Y, Method M, Berkenblit A, Bello Roufai D, Van Gorp T; Gynecologic Oncology Group Partners and the European Network of Gynaecological Oncological Trial Groups. Mirvetuximab Soravtansine in FRalpha-Positive, Platinum-Resistant Ovarian Cancer. N Engl J Med. 2023 Dec 7;389(23):2162-2174. doi: 10.1056/NEJMoa2309169.
- pmid
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- Updated: May 14, 2025
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Preserved source evidence · Not medical advice