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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04296890




Registration number
NCT04296890
Ethics application status
Date submitted
27/02/2020
Date registered
5/03/2020
Date last updated
25/07/2023

Titles & IDs
Public title
A Study of Mirvetuximab Soravtansine in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression
Scientific title
SORAYA: A Phase 3, Single Arm Study of Mirvetuximab Soravtansine 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
2020-000179-19
Secondary ID [2] 0 0
IMGN853-0417
Universal Trial Number (UTN)
Trial acronym
SORAYA
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

Experimental: Treatment - All patients will receive single-agent mirvetuximab soravtansine (MIRV) at 6 mg/kg adjusted ideal body weight (AIBW) administered on Day 1 of every 3-week cycle (Q3W).


Treatment: Drugs: Mirvetuximab Soravtansine
Mirvetuximab Soravtansine is an antibody drug conjugate designed to target folate receptor a (FRa). It consists of the humanized anti-FRa mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [1] 0 0
Duration of Response (DOR)
Timepoint [1] 0 0
Up to 2 years
Secondary outcome [2] 0 0
Adverse Events (AEs)
Timepoint [2] 0 0
Up to 2 years
Secondary outcome [3] 0 0
Progression-Free Survival (PFS)
Timepoint [3] 0 0
Up to 2 years
Secondary outcome [4] 0 0
Overall Survival (OS)
Timepoint [4] 0 0
Up to 2 years
Secondary outcome [5] 0 0
CA-125 Response
Timepoint [5] 0 0
Up to 2 years

Eligibility
Key inclusion criteria
1. Female patients = 18 years of age

2. Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian
cancer (EOC), primary peritoneal cancer, or fallopian tube cancer

3. Patients must have platinum-resistant disease:

1. Patients who have only had 1 line of platinum based therapy must have received at
least 4 cycles of platinum, must have had a response (complete response/remission
(CR) or partial response/remission (PR)) and then progressed between > 3 months
and = 6 months after the date of the last dose of platinum

2. Patients 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: Patients who are platinum refractory during front-line treatment are excluded
(see exclusion criteria)

4. Patients must have progressed radiographically on or after their most recent line of
anticancer therapy.

5. Patients 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 Folate Receptor a (FRa) positivity

6. Patient's tumor must be positive for FRa expression as defined by the Ventana FOLR1
Assay

7. Patients must have at least 1 lesion that meets the definition of measurable disease
by RECIST v1.1 (radiologically measured by the Investigator)

8. Patients must have received at least 1 but no more than 3 prior systemic lines of
anticancer therapy, including at least 1 line of therapy containing bevacizumab, and
for whom single-agent therapy is appropriate as the next line of treatment:

1. Adjuvant ± neoadjuvant considered 1 line of therapy

2. Maintenance therapy (e.g., bevacizumab, poly adenosine diphosphate-ribose
polymerase (PARP) inhibitors) will be considered part of the preceding line of
therapy (i.e., not counted independently)

3. Therapy changed due to toxicity in the absence of progression will be considered
part of the same line (i.e., not counted independently)

4. Hormonal therapy will be counted as a separate line of therapy unless it was
given as maintenance

9. Patients must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS)
of 0 or 1

10. Patients must have completed prior therapy within the specified times below:

1. Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is
shorter) prior to first dose of MIRV

2. Focal radiation completed at least 2 weeks prior to first dose of MIRV

11. Patients must have stabilized or recovered (Grade 1 or baseline) from all prior
therapy-related toxicities (except alopecia)

12. Patients must have completed any major surgery at least 4 weeks prior to first dose of
MIRV and have recovered or stabilized from the side effects of prior surgery

13. Patients must have adequate hematologic, liver and kidney functions defined as:

1. Absolute neutrophil count (ANC) = 1.5 x 10^9/L (1,500/µL) without G-CSF in the
prior 10 days or long-acting 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 (patients with documented diagnosis of Gilbert
syndrome are eligible if total bilirubin < 3.0 x ULN)

7. Serum albumin = 2 g/dL

14. Patients 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) (as defined in Section 5.8.6 of the protocol) while on MIRV
and for at least 3 months after the last dose

16. WCBP must have a negative pregnancy test within the 4 days prior to the first dose of
MIRV
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Male patients

2. Patients with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed
tumors containing any of the above histologies, or low-grade/borderline ovarian tumor

3. Patients 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

4. Patients with prior wide-field radiotherapy (RT) affecting at least 20 percent of the
bone marrow

5. Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for
Adverse Events (CTCAE)

6. Patients 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

7. Patients 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
prior to the first dose of MIRV

Note: Testing at screening is not required for the above infections unless clinically
indicated

8. Patients with a history of multiple sclerosis (MS) or other demyelinating disease
and/or Lambert-Eaton syndrome (paraneoplastic syndrome)

9. Patients with clinically significant cardiac disease including, but not limited to,
any 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

10. Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to
enrollment

11. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)

12. Patients with a previous clinical diagnosis of noninfectious interstitial lung disease
(ILD), including noninfectious pneumonitis

13. Patients requiring use of folate-containing supplements (eg, folate deficiency)

14. Patients with prior hypersensitivity to monoclonal antibodies (mAb)

15. Women who are pregnant or breastfeeding

16. Patients who received prior treatment with MIRV or other FRa-targeting agents

17. Patients with untreated or symptomatic central nervous system (CNS) metastases

18. Patients with a history of other malignancy within 3 years prior to enrollment.

Note: patients with tumors with a negligible risk for metastasis or death (eg,
adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or
carcinoma in situ of the cervix or breast) are eligible

19. Prior known hypersensitivity reactions to study drugs and/or any of their excipients

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/11/2022
Sample size
Target
Accrual to date
Final
106
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St. Leonards
Recruitment hospital [2] 0 0
ICON Cancer Care - Auchenflower
Recruitment hospital [3] 0 0
Peninsula and South Eastern Haematology & Oncology Group - Frankston
Recruitment hospital [4] 0 0
St John of God Subiaco Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
2065 - St. Leonards
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
United States of America
State/province [20] 0 0
Wisconsin
Country [21] 0 0
Belgium
State/province [21] 0 0
Bruxelles
Country [22] 0 0
Belgium
State/province [22] 0 0
Luxembourg
Country [23] 0 0
Belgium
State/province [23] 0 0
Gent
Country [24] 0 0
Belgium
State/province [24] 0 0
Leuven
Country [25] 0 0
Belgium
State/province [25] 0 0
Namur
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Sofia
Country [27] 0 0
Czechia
State/province [27] 0 0
Prague
Country [28] 0 0
Germany
State/province [28] 0 0
Baden-Württemberg
Country [29] 0 0
Germany
State/province [29] 0 0
Niedersachsen
Country [30] 0 0
Germany
State/province [30] 0 0
Essen
Country [31] 0 0
Ireland
State/province [31] 0 0
Leinster
Country [32] 0 0
Ireland
State/province [32] 0 0
Munster
Country [33] 0 0
Ireland
State/province [33] 0 0
Dublin
Country [34] 0 0
Israel
State/province [34] 0 0
Haifa
Country [35] 0 0
Israel
State/province [35] 0 0
Jerusalem
Country [36] 0 0
Israel
State/province [36] 0 0
Kfar Saba
Country [37] 0 0
Israel
State/province [37] 0 0
Ramat Gan
Country [38] 0 0
Israel
State/province [38] 0 0
Rehovot
Country [39] 0 0
Israel
State/province [39] 0 0
Safed
Country [40] 0 0
Italy
State/province [40] 0 0
Bologna
Country [41] 0 0
Italy
State/province [41] 0 0
Brescia
Country [42] 0 0
Italy
State/province [42] 0 0
Candiolo
Country [43] 0 0
Italy
State/province [43] 0 0
Catania
Country [44] 0 0
Italy
State/province [44] 0 0
Milano
Country [45] 0 0
Italy
State/province [45] 0 0
Napoli
Country [46] 0 0
Italy
State/province [46] 0 0
Perugia
Country [47] 0 0
Italy
State/province [47] 0 0
Roma
Country [48] 0 0
Poland
State/province [48] 0 0
Silesia
Country [49] 0 0
Poland
State/province [49] 0 0
Warminsko-Mazurskie
Country [50] 0 0
Poland
State/province [50] 0 0
Lódzkie
Country [51] 0 0
Spain
State/province [51] 0 0
Barcelona
Country [52] 0 0
Spain
State/province [52] 0 0
Castellana
Country [53] 0 0
Spain
State/province [53] 0 0
Galicia
Country [54] 0 0
Spain
State/province [54] 0 0
Córdoba
Country [55] 0 0
Spain
State/province [55] 0 0
Girona
Country [56] 0 0
Spain
State/province [56] 0 0
Madrid
Country [57] 0 0
Spain
State/province [57] 0 0
Murcia
Country [58] 0 0
Spain
State/province [58] 0 0
Sabadell
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ImmunoGen, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to evaluate the efficacy and safety of mirvetuximab soravtansine
(MIRV) in patients with platinum-resistant high-grade serous epithelial ovarian cancer,
primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of Folate
Receptor-Alpha (FRa). Patients will be, in the opinion of the Investigator, appropriate for
single-agent therapy for their next line of therapy. All patients will receive single-agent
MIRV at 6 mg/kg adjusted ideal body weight administered on Day 1 of every 3-week cycle.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04296890
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Method, MPH, MBA
Address 0 0
ImmunoGen, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04296890