MIRASOL: A 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

• Sponsor: ImmunoGen, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04209855
• Collaborator: Gynecologic Oncology Group (Other), European Network of Gynaecological Oncological Trial Groups (ENGOT) (Other)
• Enrollment: 430
• Locations: 209
• Arms: 2
• Anticipated Duration (Months): 51
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This Phase 3 study is designed to compare the efficacy and safety of mirvetuximab soravtansine vs. investigator's choice chemotherapy in patients with platinum-resistant high-grade epithelial ovarian cancer, primary peritoneal, or fallopian tube cancer, whose tumors express a high-level of FRα. Patients will be, in the opinion of the Investigator, appropriate for single-agent therapy for their next line of therapy. Folate receptor alpha (FRα) positivity will be defined by the Ventana FOLR1 (FOLR1-2.1) CDx assay.

Condition or Disease	Intervention/Treatment	Phase
Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer	Drug: Mirvetuximab Soravtansine; Drug: Paclitaxel; Drug: Topotecan; Drug: Pegylated liposomal doxorubicin	Phase 3

Detailed Description

Patients will be randomized to either mirvetuximab soravtansine (MIRV) or Investigator's Choice chemotherapy (paclitaxel, PEGylated liposomal doxorubicin, or topotecan).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 430 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official 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
• Actual Study Start Date: Dec 31, 2019
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Apr 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mirvetuximab soravtansine (MIRV; IMGN853) MIRV 6 mg/kg adjusted ideal body weight (AIBW) every 3 weeks (Q3W)	Drug: Mirvetuximab Soravtansine; Mirvetuximab soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.; Other Names: MIRV IMGN853
Active Comparator: Investigator's choice of chemotherapy Paclitaxel (Pac; 80 mg/m2) administered once per week (QW) within a 4-week cycle Pegylated liposomal doxorubicin (PLD; 40 mg/m2) administered every 4 weeks (Q4W) Topotecan (Topo; 4 mg/m2) administered either on Days 1, 8, and 15 every 4 weeks or for 5 consecutive days (1.25 mg/m2 Days 1-5) every 3 weeks (Q3W)	Drug: Paclitaxel; Paclitaxel is a taxane that can stabilize microtubules to inhibit cell division. It was approved for treatment of recurrent epithelial ovarian cancer.; Drug: Topotecan; Topotecan induces irreversible DNA damage. It inhibits topoisomerase 1, leading to both single and double strand DNA break that eventually promote apoptosis. Topotecan was approved for treatment of epithelial ovarian cancer after failure of initial or subsequent chemotherapy.; Drug: Pegylated liposomal doxorubicin; Pegylated liposomal doxorubicin is a standard chemotherapy regimen used for treating platinum-resistant ovarian cancer. The active component doxorubicin is an anthracycline that intercalates DNA, leading to inhibition of replication and subsequently, the inhibition of proper cell division.

Outcome Measures

Primary Outcome Measures

1. Progression-free survival (PFS) [Up to 2 years]

   The time from date of randomization until Investigator-assessed progressive disease or death, whichever occurs first.

Secondary Outcome Measures

1. Safety and tolerability [Up to 2 years]

   Adverse events (AEs) will be evaluated according to the NCI CTCAE v5.0. AEs will be coded using the latest Medical Dictionary for Regulatory Activities (MedDRA) version and summarized per system organ class (SOC) and preferred term (PT).

2. Objective Response Rate (ORR) [Up to 2 years]

   Objective response includes best response of complete response (CR) or partial response (PR).

3. Overall survival [Up to 2 years]

   The time from date of randomization until the date of death

4. Primary patient-reported outcomes [Up to 2 years]

   The number of patients achieving at least 15 point absolute improvement at Week 8 or Week 9 in the abdominal/GI scale of the European Organization for Research and Treatment of Cancer (EORTC) ovarian cancer specific quality of life questionnaire (QLQ-OV28). A higher score represents a better quality of life.

5. Duration of response (DOR) [Up to 2 years]

   The time from initial response until Investigator-assessed progressive disease for all patients who achieve a confirmed objective response

6. CA-125 response [Up to 2 years]

   Serum CA-125 response determined using the GCIG criteria

7. Progression-free survival 2 (PFS 2) [Up to 2 years]

   The time from date of randomization until second disease progression or death whichever occurs first. Results will be summarized by arm

Other Outcome Measures

1. Patient-reported outcomes using EORTC QLQ-C30 questionnaires [Up to 2 years]

   The EORTC QLQ-C30 questionnaires will be used to collect data on the patient's functioning, health-related QOL, disease symptoms and health status. A higher score represents a higher response level.

2. Patient-reported outcomes using EQ-5D-5L questionnaires [Up to 2 years]

   The EuroQol-5 Dimension 5-level (EQ-5D-5L) questionnaires will be used to collect data on the patient's functioning, health-related QOL, disease symptoms and health status. A higher score represents a higher response level.

3. Pharmacokinetic parameters [Up to 2 years]

   Plasma samples will be collected to determine the concentration of MIRV (antibody-drug conjugate, total antibody, free DM4, S-methyl DM4 and possibly other metabolites). Summary statistics of the concentration at each time point (nominal time) will be presented. Graphical presentation of the data may also be completed using nominal time.

4. Immunogenicity [Up to 2 years]

   The presence of anti-drug antibodies to mirvetuximab soravtansine

5. Identification of soluble FRα levels and other biomarkers [Up to 2 years]

6. Patient-reported outcomes using PGIS questionnaires [Up to 2 years]

   The Patient Global Impression of Severity (PGIS) questionnaires will be used to collect data on the patient's perception of overall cancer symptom severity. This is a single question survey.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Female patients ≥ 18 years of age

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

3. Patients must have platinum-resistant disease:

4. 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 (CR or PR) and then progressed between >3 months and ≤ 6 months after the date of the last dose of platinum

5. 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

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

7. 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 IHC confirmation of FRα positivity

8. Patient's tumor must be positive for FRα expression as defined by the Ventana FOLR1 (FOLR-2.1) CDx assay

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

10. Patients 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:

11. Adjuvant ± neoadjuvant considered one line of therapy

12. Maintenance therapy (eg, bevacizumab, PARP inhibitors) will be considered as part of the preceding line of therapy (ie, not counted independently)

13. Therapy changed due to toxicity in the absence of progression will be considered as part of the same line (ie, not counted independently)

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

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

16. Time from prior therapy:

17. Systemic antineoplastic therapy (5 half-lives or 4 weeks, whichever is shorter)

18. Focal radiation completed at least 2 weeks prior to first dose of study drug

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

20. 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

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

22. 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

23. Platelet count ≥ 100 x 10^9/L (100,000/μL) without platelet transfusion in the prior 10 days

24. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 21 days

25. Serum creatinine ≤ 1.5 x upper limit of normal (ULN)

26. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN

27. Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 x ULN

28. Serum albumin ≥ 2 g/dL

29. 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

30. Women of childbearing potential (WCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.9.6 in the protocol) 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

31. WCBP must have a negative pregnancy test within 4 days prior to the first dose of study drug

Exclusion Criteria:

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

2. 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

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

4. Patients with > Grade 1 peripheral neuropathy per CTCAE v5.0

5. 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

6. Patients with serious concurrent illness or clinically relevant active infection, including, but not limited to the following:

7. Active hepatitis B or C infection (whether or not on active antiviral therapy)

8. HIV infection

9. Active cytomegalovirus infection

10. 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

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

12. Patients with clinically significant cardiac disease including, but not limited to, any one of the following:

13. Myocardial infarction ≤ 6 months prior to first dose

14. Unstable angina pectoris

15. Uncontrolled congestive heart failure (New York Heart Association > class II)

16. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)

17. Uncontrolled cardiac arrhythmias

18. Patients 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

19. Patients with a history of hemorrhagic or ischemic stroke within six months prior to randomization

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

21. Patients with a previous clinical diagnosis of non-infectious interstitial lung disease (ILD), including noninfectious pneumonitis

22. Patients with required use of folate-containing supplements (eg, folate deficiency)

23. Patients with prior hypersensitivity to monoclonal antibodies

24. Women who are pregnant or lactating

25. Patients with prior treatment with MIRV or other FRα-targeting agents

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

27. Patients 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 (eg, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast

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

29. 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

30. Simultaneous participation in another research study, in countries or localities where this is the health authority guidance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham (UAB) GYN Oncology	Birmingham	Alabama	United States	35233
2	Alaska Women's Cancer Care	Anchorage	Alaska	United States	99508
3	Arizona Oncology Associates, PC - HAL - USOR	Phoenix	Arizona	United States	85016
4	Mayo Clinic	Phoenix	Arizona	United States	85054
5	Mayo Clinic	Phoenix	Arizona	United States	85054
6	USOR: Arizona Oncology Associates, PC - HOPE	Tucson	Arizona	United States	85711
7	University of Arizona Cancer Center	Tucson	Arizona	United States	85719
8	UCLA - JCCC Dept of OBGYN - Women's Health Clinical Research Unit	Los Angeles	California	United States	90095
9	Hoag Cancer Center	Newport Beach	California	United States	92663
10	University of California San Francisco	San Francisco	California	United States	94143
11	Olive View - UCLA Medical Center	Sylmar	California	United States	91324
12	Kaiser Permanente Oncology Clinical Trials	Vallejo	California	United States	94589
13	USOR: Rocky Mountain Cancer Centers	Lakewood	Colorado	United States	80228
14	Yale University School of Medicine	New Haven	Connecticut	United States	06520
15	Florida Cancer Specialist South Division	Fort Myers	Florida	United States	33901
16	Mayo Clinic Jacksonville	Jacksonville	Florida	United States	32224
17	Women's Care Florida / Women's Cancer Associates	Saint Petersburg	Florida	United States	33701
18	Florida Cancer Specialist North Division	Saint Petersburg	Florida	United States	33705
19	Sarasota Memorial Hospital	Sarasota	Florida	United States	34239
20	Florida Cancer Specialists	Tallahassee	Florida	United States	32308
21	Florida Cancer Specialist East Division	West Palm Beach	Florida	United States	33401
22	Memorial University Medical Center	Savannah	Georgia	United States	31404
23	Hawaii Pacific Health - Kapiolani Medical Center for Women and Children	Honolulu	Hawaii	United States	96813
24	Illinois Cancer Specialists	Arlington Heights	Illinois	United States	60005
25	University of Chicago	Chicago	Illinois	United States	60637
26	Dr. Sudarshan K. Sharma, Ltd.	Hinsdale	Illinois	United States	60521
27	Community Health Network	Indianapolis	Indiana	United States	46250
28	University of Kansas Cancer Center	Westwood	Kansas	United States	66205
29	St. Elizabeth Healthcare	Edgewood	Kentucky	United States	41017
30	Norton Cancer Institute	Louisville	Kentucky	United States	40207
31	Ochnser Medical Center Jefferson	New Orleans	Louisiana	United States	70121
32	WK Physicians Network/Gynecologic Oncology Associates	Shreveport	Louisiana	United States	771103
33	Holy Cross Hospital	Silver Spring	Maryland	United States	20902
34	USOR: Maryland Oncology Hematology, P.A.	Silver Spring	Maryland	United States	20902
35	Tufts Medical Center	Boston	Massachusetts	United States	02111
36	Baystate Medical Center	Springfield	Massachusetts	United States	01199
37	University of Massachusetts	Worcester	Massachusetts	United States	01605
38	St. Joseph Mercy Hospital	Ann Arbor	Michigan	United States	48106
39	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
40	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
41	USOR: Minnesota Oncology Hematology, PA	Woodbury	Minnesota	United States	55125
42	HCA Midwest Kansas City/ Sarah Cannon	Kansas City	Missouri	United States	64132
43	Sletten Cancer Institute	Great Falls	Montana	United States	59405
44	Center of Hope	Reno	Nevada	United States	89511
45	The Valley Hospital, Inc	Ridgewood	New Jersey	United States	07450
46	Holy Name Medical Center	Teaneck	New Jersey	United States	07666
47	Columbia University Medical Center	New York	New York	United States	10032
48	FirstHealth of the Carolinas Outpatient Cancer Center	Pinehurst	North Carolina	United States	28374
49	USOR: OHC - Oncology_Hematology Care Clinical Trials, Inc.	Cincinnati	Ohio	United States	45242
50	MetroHealth Medical Center	Cleveland	Ohio	United States	44109
51	Cleveland Clinic	Cleveland	Ohio	United States	44195
52	Columbus NCORP	Columbus	Ohio	United States	43215
53	Zangmeister Cancer Center	Columbus	Ohio	United States	43219
54	The Ohio State University Wexner Medical Center	Hilliard	Ohio	United States	43026
55	Stephenson Cancer Center	Oklahoma City	Oklahoma	United States	73104
56	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma	United States	74146
57	USOR: Willamette Valley Cancer Institute and Research Center	Eugene	Oregon	United States	97401
58	Legacy Gynecologic Oncology	Portland	Oregon	United States	97210
59	USOR: Northwest Cancer Specialists, P.C.	Portland	Oregon	United States	97227
60	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
61	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
62	Magee-Women's Hospital-UPMC	Pittsburgh	Pennsylvania	United States	15213
63	West Penn Hospital	Pittsburgh	Pennsylvania	United States	15224
64	Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
65	Tennessee Oncology / Sarah Cannon Research Institute	Nashville	Tennessee	United States	37203
66	USOR: Texas Oncology-South Austin	Austin	Texas	United States	78745
67	USOR: Texas Oncology - Fort Worth Cancer Center	Fort Worth	Texas	United States	76104
68	University of Texas, Memorial Hermann	Houston	Texas	United States	77030
69	USOR: Texas Oncology - McAllen South Second	McAllen	Texas	United States	78503
70	USOR: Texas Oncology - San Antonio	San Antonio	Texas	United States	78240
71	USOR: Texas Oncology, P.A.	Sugar Land	Texas	United States	77479
72	USOR: Texas Oncology - The Woodlands, Gynecologic Oncology	The Woodlands	Texas	United States	77380
73	USOR: Texas Oncology - Tyler	Tyler	Texas	United States	75702
74	USOR: Texas Oncology, P.A.	Webster	Texas	United States	77598
75	University of Virginia Health System	Charlottesville	Virginia	United States	22908
76	USOR: Virginia Cancer Specialists, PC	Gainesville	Virginia	United States	20155
77	Kadlec Clinic Hematology & Oncology	Kennewick	Washington	United States	99336
78	West Virginia University- MBRCC	Morgantown	West Virginia	United States	26506
79	Newcastle Private Hospital	New Lambton Heights	New South Wales	Australia	2305
80	Prince of Wales Hospital	Randwick	New South Wales	Australia	2031
81	Monash Health	Clayton	Victoria	Australia	3168
82	Oncology Clinics Victoria (OCV) - Cabrini Malvern Hospital Location	Malvern	Victoria	Australia	3144
83	Royal North Shore Hospital	Saint Leonards		Australia	2065
84	Burnside War Memorial Hospital - The Brian Fricker Oncology Centre	Toorak Gardens		Australia	5065
85	OLV Ziekenhuis	Aalst		Belgium	9300
86	AZ Klina	Brasschaat		Belgium	2390
87	Universitair Ziekenhuis Antwerpen (UZA) - Borstkliniek	Edegem		Belgium	2650
88	AZ St-Lucas	Gent		Belgium	9000
89	UZ Leuven	Leuven		Belgium	3000
90	UMHAT Georgi Stranski	Pleven		Bulgaria	5800
91	Acibadem City Clinic Tokuda Hospital	Sofia		Bulgaria	1407
92	UMHAT "Sv. Ivan Rilski", EAD, Sofia	Sofia		Bulgaria	1431
93	Tom Baker Cancer Centre	Calgary	Alberta	Canada	T2N 4N2
94	Cross Cancer Institute	Edmonton	Alberta	Canada	T6G 1Z2
95	The Ottawa Hospital General Campus	Ottawa	Ontario	Canada	K1H8L6
96	Sunnybrook Health Sciences Center	Toronto	Ontario	Canada	M4N 3M5
97	Princess Margaret Cancer Centre - University Health Network	Toronto	Ontario	Canada	M5G 2M9
98	McGill University Health Centre	Montreal	Quebec	Canada	H4A 3J1
99	Centre Hospitalier de L'Universite de Montreal	Montréal	Quebec	Canada	H2X 0A9
100	Centre Hospitalier Universitaire de Sherbrooke	Sherbrooke	Quebec	Canada	J1H 5N4
101	Anhui Provincial Cancer Hospital	Hefei	Anhui	China	230000
102	Fujian Cancer Hospital	Fuzhou	Fujian	China	350014
103	Sun Yat-sen University, Cancer Center	Guangzhou	Guangdong	China	510060
104	Wuhan Union Hospital of China	Wuhan	Hubei	China	430024
105	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China	430061
106	Hubei Cancer Hospital	Wuhan	Hubei	China	430079
107	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006
108	The First Hospital of Jilin University	Changchun	Jilin	China	130031
109	Liaoning Cancer Hospital	Shenyang	Liaoning	China	110801
110	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China	710061
111	Peking University First Hospital	Beijing		China	100034
112	Beijing Cancer Hospital	Beijing		China	100142
113	Fudan University Shanghai Cancer Center	Shanghai		China	200032
114	Tianjin Medical University Cancer Institute & Hospital	Tianjin		China	300060
115	Fakultní nemocnice Ostrava	Ostrava		Czechia	708 52
116	Všeobecná fakultní nemocnice v Praze	Praha 2		Czechia	128 51
117	KNTB a.s. Zlín	Zlín		Czechia	762 75
118	Institut Claudius Regaud	Toulouse	Cedex 9	France	31059
119	Centre Oscar Lambret	Lille	Cedex B.P 307	France	59020
120	Institut de cancérologie de l'ouest, site Angers	Angers	Cedex	France	49055
121	CHRU Besançon	Besançon Cedex		France	25030
122	Institut Bergonie	Bordeaux Cedex		France	33076
123	Centre Leon Berard	Lyon Cedex		France	69373
124	Institut Paoli Calmettes	Marseille		France	13009
125	Cochin Hospital	Paris		France	75014
126	Groupe Hospitalier Diaconesses Croix Saint-Simon	Paris		France	75960 Cedex 20
127	Centre Hospitalier Lyon Sud	Pierre-Bénite		France	69310
128	Centre Armoricain de radiothérapie, imagerie médicale et oncologie, CARIO	Plerin		France	22190
129	Institut Curie	Saint Cloud		France	92210
130	ICO Centre René Gauducheau	St. Herblain CEDEX		France	44805
131	Institut de cancérologie de Lorraine	Vandoeuvre les Nancy_ Cedex		France	54519
132	Gustave Roussy	Villejuif Cedex		France	94805
133	Ulm University Hospital Klinik für Frauenheilkunde und Geburtshilfe	Ulm	Baden-Württemberg	Germany	89075
134	UMG Göttingen Frauenklinik	Göttingen	Niedersachsen	Germany	37075
135	Universitätsklinikum Carl Gustav Carus Dresden	Dresden	Saxony	Germany	01307
136	Universitätsklinikum Bonn	Bonn		Germany	53127
137	Städtisches Klinikum Dessau, Zentrum für Klinische Studien	Dessau		Germany	06847
138	Klinikum Dortmund gGmbH / Frauenklinik	Dortmund		Germany	44137
139	University Hospital Freiburg	Freiburg		Germany	79106
140	Mammazentrum Hamburg am Krankenhaus Jerusalem	Hamburg		Germany	20357
141	Wolfson Medical Center	Holon		Israel	5822012
142	Hadassah Ein Kerem Medical center	Jerusalem		Israel	POB 12000
143	Meir Medical Center	Kfar Saba		Israel	4428164
144	Sheba Medical Center	Ramat Gan		Israel	5265601
145	Kaplan Medical Center	Rehovot		Israel	76100
146	Ziv Medical Center	Safed		Israel	13100
147	IOV Istituto Oncologico	Padova	PD	Italy	35128
148	Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia	Brescia		Italy	25123
149	ASST Lecco- Ospedale A.Manzoni	Lecco		Italy	23900
150	IRCCS - Istituto Europeo di Oncologia (The European Institute of Oncology) (IEO)	Milan		Italy	20141
151	INT Pascale	Naples		Italy	80131
152	Oncologia Azienda Osc-IRCCS Reggio Emilia	Reggio Emilia		Italy	42123
153	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome		Italy	00168
154	Azienda Ospedaliera Città Della Salute E Della Scienza Di Torino	Torino		Italy	10126
155	Ospedale Mauriziano Umberto I	Torino		Italy	10128
156	National Cancer Center - Center for Uterine Cancer	Gyeonggi-do		Korea, Republic of	10408
157	Seoul National University Bundang Hospital	Seongnam-si		Korea, Republic of	13620
158	Seoul National University Hospital	Seoul		Korea, Republic of	03080
159	Severance Hospital	Seoul		Korea, Republic of	03722
160	University of Ulsan College of Medicine - Asan Medical Center	Seoul		Korea, Republic of	05505
161	Samsung Medical Center	Seoul		Korea, Republic of	06351
162	Amsterdam UMC	Amsterdam		Netherlands	1105 AZ
163	Maastricht UMC	Maastricht		Netherlands	6229 HX
164	Radboud University Medical Center	Nijmegen		Netherlands	Postbus 9101, 6500 HB
165	Erasmus Medical Center	Rotterdam		Netherlands	3015 AA
166	Medical University of Gdansk	Gdańsk		Poland	80-214
167	Samodzielny publiczny szpital kliniczny nr 1	Lublin		Poland	20-081
168	Wojewódzki Szpital Specjalistyczny, Oddzial Kliniczny Ginekologii Onkologiczne	Olsztyn		Poland	10-561
169	Wielkopolskie Centrum Onkologii	Poznań		Poland	61-866
170	Szpital Kliniczny im. Ks. Anny Mazowieckiej	Warszawa		Poland	00-315
171	Fundação Champalimaud	Lisbon		Portugal	1400-038
172	Hospital da Luz, S.A	Lisbon		Portugal	1500-650
173	Centro Hospitalar de Lisboa Norte, E.P.E. - Hospital de Santa Maria	Lisbon		Portugal	1649-028
174	Hospital Beatriz Angelo	Loures		Portugal	2674-514
175	BIH of Omsk Region "Clinical Oncology Dispensary"	Omsk	Omsk Oblast	Russian Federation	644013
176	LLC "VitaMed"	Moscow		Russian Federation	10
177	Leningrad regional oncology dispensa	St-Petersburg		Russian Federation	194356
178	State Autonomous Healthcare Institution Republican Clinical Oncological Dispensary of the MoH of Republic Bashkortostan	Ufa		Russian Federation	450054
179	Oncology and Radiology Institute Serbia	Belgrade		Serbia	11000
180	Clinical Center Kragujevac	Kragujevac		Serbia	34000
181	Oncology Institute Vojvodina, Surgical Oncology Clinic	Sremska Kamenica		Serbia	21204
182	Hospital Clínico de Santiago	Santiago de Compostela	A Coruña	Spain	15706
183	H. U. de Jaén	Jaén	Andalucia	Spain	23007
184	Hospital Universitario Infanta Sofía	San Sebastián de los Reyes	Madrid	Spain	28702
185	Institut Català d'Oncologia	Badalona		Spain	8916
186	H. San Pedro de Alcántara	Caceres		Spain	10003
187	Hospital Provincial de Castellon	Castelló		Spain	12002
188	Hospital de San Chinarro-Clara Campal	Madrid		Spain	28050
189	Hospital Clínico Universitario Virgen de la Arrixaca	Murcia		Spain	30120
190	Parc Taulí	Sabadell		Spain	8208
191	Virgen del Rocío	Sevilla		Spain	41013
192	Hospital de la Fe	Valencia		Spain	46026
193	HCU Lozano Blesa	Zaragoza		Spain	50009
194	Far Eastern Memorial Hospital	New Taipei City		Taiwan	220
195	Mackay Memorial Hospital - Taipei Branch	Taipei City		Taiwan	10449
196	Taipei Veterans General Hospital	Taipei City		Taiwan	11217
197	Chernihiv Medical Center of Modern Oncology of Chernihiv Regional Council	Chernihiv	Chernihiv Region	Ukraine	14029
198	Grigoriev Institute for Medical Radiology NAMS of Ukraine	Kharkiv	Kharkiv Region	Ukraine	61024
199	Communal non-profit enterprise "Khmelnytskyi Regional Antitumor Center" of Khmelnytskoyi Regional Council	Khmelnytskyi	Khmelnytskyi Region	Ukraine	29009
200	Communal non-profit enterprise "Cherkasy Regional Oncology Dispensary of Cherkasy oblast council"	Cherkasy		Ukraine	18009
201	Prykarpatskyi Clinical Oncology Center of Ivano-Frankivsk Regional Council	Ivano-Frankivsk		Ukraine	76018
202	Peterborough City Hospital	Peterborough	Cambridgeshire	United Kingdom	PE3 9GZ
203	Royal Devon and Exeter Hospital (Wonford)	Exeter	Devon	United Kingdom	EX2 5DW
204	University Hospitals Coventry and Warwickshire	Coventry		United Kingdom	CV2 2DX
205	Beatson West of Scotland Cancer Centre	Glasgow		United Kingdom	G12 0YN
206	St Bartholomew's Hospital-Barts Health NHS Trust	London		United Kingdom	EC1A 7BE
207	University College London Hospital	London		United Kingdom	NW1 2PG
208	The Royal Marsden NHS Foundation Trust	London		United Kingdom	SM2 5PT
209	The Christie NHS Foundation Trust	Manchester		United Kingdom	M20 4BX

Sponsors and Collaborators

• ImmunoGen, Inc.
• Gynecologic Oncology Group
• European Network of Gynaecological Oncological Trial Groups (ENGOT)

Investigators

• Study Director: Michael Method, MPH, MBA, ImmunoGen, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ImmunoGen, Inc.
• ClinicalTrials.gov Identifier: NCT04209855
• Other Study ID Numbers: IMGN853-0416; 2019-003509-80
• First Posted: Dec 24, 2019
• Last Update Posted: Jun 16, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by ImmunoGen, Inc.: Platinum-resistant; Folate-receptor alpha expression; Phase 3; Antibody-drug conjugate; mirvetuximab soravtansine; IMGN853; Epithelial Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Paclitaxel; Maytansine; Doxorubicin; Liposomal doxorubicin; Topotecan

Study Results

No Results Posted as of Jun 16, 2022