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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04209855




Registration number
NCT04209855
Ethics application status
Date submitted
17/12/2019
Date registered
24/12/2019
Date last updated
1/08/2024

Titles & IDs
Public title
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 (FRa) Expression
Scientific title
MIRASOL: A Randomized, Open-label, Phase 3 Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
Secondary ID [1] 0 0
2019-003509-80
Secondary ID [2] 0 0
IMGN853-0416
Universal Trial Number (UTN)
Trial acronym
MIRASOL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epithelial Ovarian Cancer 0 0
Peritoneal Cancer 0 0
Fallopian Tube Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mirvetuximab Soravtansine
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Topotecan
Treatment: Drugs - Pegylated liposomal doxorubicin

Experimental: Mirvetuximab Soravtansine - 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).

Active comparator: Investigator's Choice (IC) Chemotherapy - 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.


Treatment: Drugs: Mirvetuximab Soravtansine
Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered per dose and schedule specified in the arm.

Treatment: Drugs: Topotecan
Topotecan will be administered per dose and schedule specified in the arm.

Treatment: Drugs: Pegylated liposomal doxorubicin
Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Timepoint [1] 0 0
From randomization until PD or death, whichever occurred first (up to 28 months)
Secondary outcome [1] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Up to 28 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR), as Assessed by the Investigator Using RECIST v1.1
Timepoint [2] 0 0
Up to 28 months
Secondary outcome [3] 0 0
Overall Survival Assessed by the Investigator Using RECIST v1.1
Timepoint [3] 0 0
Up to 30 months
Secondary outcome [4] 0 0
Number of Participants Achieving at Least 15 Point Absolute Improvement at Week 8 or 9 in the Abdominal/GI Scale of European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Ovarian Cancer Module 28 (QLQ-OV28)
Timepoint [4] 0 0
Baseline and Week 8 or 9
Secondary outcome [5] 0 0
Duration of Response (DOR) as Assessed by the Investigator Using RECIST v1.1
Timepoint [5] 0 0
Up to 28 months
Secondary outcome [6] 0 0
Percentage of Participants With CA-125 Confirmed Clinical Response Per Gynecologic Cancer Intergroup (GCIG) Criteria
Timepoint [6] 0 0
Up to 28 months
Secondary outcome [7] 0 0
Time to Second Progression-Free Survival (PFS 2)
Timepoint [7] 0 0
Up to 28 months

Eligibility
Key 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 FRa positivity
6. Participant's tumor must be positive for FRa 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
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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 FRa-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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/12/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/08/2024
Actual
Sample size
Target
Accrual to date
Final
453
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Newcastle Private Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location - Malvern
Recruitment hospital [5] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment hospital [6] 0 0
Burnside War Memorial Hospital - The Brian Fricker Oncology Centre - Toorak Gardens
Recruitment postcode(s) [1] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
2065 - Saint Leonards
Recruitment postcode(s) [6] 0 0
5065 - Toorak Gardens
Recruitment outside Australia
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United States of America
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Alabama
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Freiburg
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Giessen
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Hamburg
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Holon
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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Safed
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Italy
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PD
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Italy
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Brescia
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Italy
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Lecco
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Rome
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Maastricht
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Portugal
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Loures
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Russian Federation
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Omsk Oblast
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Russian Federation
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Moscow
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Russian Federation
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Serbia
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Serbia
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A Coruña
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Spain
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Andalucia
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Madrid
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Badalona
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Caceres
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Castelló
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Spain
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Murcia
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Spain
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Sabadell
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Spain
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Sevilla
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Spain
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Valencia
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Spain
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Zaragoza
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Taiwan
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New Taipei City
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Taiwan
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Taipei City
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Ukraine
State/province [132] 0 0
Chernihiv Region
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Ukraine
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Kharkiv Region
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Ukraine
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Khmelnytskyi Region
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Ukraine
State/province [135] 0 0
Cherkasy
Country [136] 0 0
Ukraine
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Ivano-Frankivsk
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Cambridgeshire
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Devon
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Coventry
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United Kingdom
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Glasgow
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United Kingdom
State/province [141] 0 0
London
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ImmunoGen, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Gynecologic Oncology Group
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 FRa. Participants will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. The FRa positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.
Trial website
https://clinicaltrials.gov/study/NCT04209855
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Graham Walker, MBChB, MBA DIC
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04209855