Mirvetuximab Soravtansine With Bevacizumab Versus Bevacizumab as Maintenance in Platinum-sensitive Ovarian, Fallopian Tube, or Peritoneal Cancer (GLORIOSA)

March 28, 2024 updated by: ImmunoGen, Inc.

Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-high Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab (GLORIOSA)

GLORIOSA is a Phase 3 multicenter, open label study designed to evaluate the safety and efficacy of mirvetuximab Soravtansine as maintenance therapy in participants with platinum-sensitive ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to the tumor cells carrying a tumor-associated protein called folate receptor alpha (FRα). It is being developed as maintenance therapy for the treatment of subjects with recurrent platinum-sensitive, highgrade epithelial ovarian, primary peritoneal, or fallopian tube cancers with high folate receptor-alpha expression. Patients must have confirmation of FRα positivity by the Ventana FOLR1 Assay.

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Study Type

Interventional

Enrollment (Estimated)

418

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
  • Belgium
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre, Alberta Health Services
        • Contact:
        • Principal Investigator:
          • Prafull Ghatage, MD
      • Edmonton, Alberta, Canada, T6G1Z2
        • Recruiting
        • University of Alberta - Cross Cancer Institute (CCI)
        • Principal Investigator:
          • Jennifer Rauw, MD
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z4E6
        • Recruiting
        • BC Cancer - Vancouver
        • Contact:
          • Darko Curman
          • Phone Number: 673226 1-604-877-6000
        • Principal Investigator:
          • Alannah Smrke, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Juravinski Cancer Centre
        • Contact:
          • Nidhi Kumar-Tyagi, MD
          • Phone Number: 905-387-9495
        • Principal Investigator:
          • Nidhi Kumar-Tyagi, MD
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kinston Health Sciences Center - KGH Site
        • Contact:
          • Julie Holiday
          • Phone Number: 613-549-6666
        • Principal Investigator:
          • Andrew Robinson, MD
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital Cancer Centre
        • Contact:
        • Principal Investigator:
          • Johanne Weberpals, MD
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Principal Investigator:
          • Amit Oza, MD
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A3J1
        • Recruiting
        • McGill University Health Centre
        • Principal Investigator:
          • Lucy Gilbert, MD
        • Contact:
      • Montreal, Quebec, Canada, H2XOA9
        • Recruiting
        • Centre Hospitalier de L'Universite de Montreal - Centre de Recherche
        • Principal Investigator:
          • Diane Provencher, MD
        • Contact:
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
        • Contact:
        • Principal Investigator:
          • Lara deGuerke, MD
      • Sherbrooke, Quebec, Canada, J1H5N3
        • Recruiting
        • CHUS - Hôpital Fleurimont
        • Contact:
        • Principal Investigator:
          • Paul Bessette, MD
  • Czechia
  • Israel
  • Italy
  • Korea, Republic of
  • Philippines
      • Iloilo City, Philippines, 5000
        • Not yet recruiting
        • The Medical City - Iloilo
      • Pasig, Philippines, 1600
        • Not yet recruiting
        • The Medical City - Ortigas
      • Quezon City, Philippines, 1100
        • Not yet recruiting
        • East Avenue Medical Centre
      • San Juan, Philippines, 1502
        • Not yet recruiting
        • Cardinal Santos Medical Center
  • Spain
  • United Kingdom
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36604
        • Recruiting
        • USA Mitchell Cancer Institute
        • Principal Investigator:
          • Jennifer Scalici, MD
        • Contact:
    • California
      • Concord, California, United States, 94520
        • Recruiting
        • John Muir Health
        • Contact:
        • Principal Investigator:
          • Babak Edraki, MD
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope
        • Contact:
          • Phone Number: 877-467-3411
        • Contact:
        • Principal Investigator:
          • Joshua Cohen, MD
      • Irvine, California, United States, 92618
        • Recruiting
        • Irvine Medical Center, 6650 Alton Pkwy
        • Principal Investigator:
          • Devansu Tewari
        • Contact:
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Kaiser Permanente Los Angeles Medical Center, 4950 Sunset Blvd., 6th Floor
        • Principal Investigator:
          • Devansu Tewari
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UCI Health- Chao Family Comprehensive Cancer Center
        • Principal Investigator:
          • Krishnansu Tewari, MD
        • Contact:
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Jonathan Berek, MD
      • Riverside, California, United States, 92505
        • Recruiting
        • Kaiser Permanente Riverside Medical Center, 10800 Magnolia Ave
        • Principal Investigator:
          • Devansu Tewari
        • Contact:
      • San Diego, California, United States, 92093
        • Recruiting
        • UC San Diego Health - Moores Cancer Center
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Kaiser Permanente Zion Medical Center, 4647 Zion Ave
        • Principal Investigator:
          • Devansu Tewari
        • Contact:
      • San Marcos, California, United States, 92069
        • Recruiting
        • Kaiser Permanente San Marcos Medical Offices, 400 Craven Road
        • Principal Investigator:
          • Devansu Tewari
        • Contact:
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • Broward Health Medical Center
        • Contact:
        • Principal Investigator:
          • Scott Jordan, MD
      • Fort Myers, Florida, United States, 33905
        • Recruiting
        • Regional Cancer Center/ Florida Gynecologic Oncology
        • Principal Investigator:
          • Edward Grendys, MD
        • Contact:
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Principal Investigator:
          • Lauren Hand, MD
        • Contact:
      • Miami, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center
        • Principal Investigator:
          • Brian Slomovitz, MD
        • Contact:
      • Sarasota, Florida, United States, 34239
        • Recruiting
        • Sarasota Memorial Health Care System
        • Contact:
        • Principal Investigator:
          • Beverly Long, MD
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital
        • Principal Investigator:
          • Meaghan Tenney, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Not yet recruiting
        • University of Chicago
        • Principal Investigator:
          • John Moroney, MD
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University Medical Center
        • Contact:
          • Lois Winkelman, RN
          • Phone Number: 312-942-2417
        • Principal Investigator:
          • Summer Dewdney, MD
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center, 1725 West Harrison Street
        • Contact:
        • Contact:
          • Phone Number: 616-486-6000
        • Principal Investigator:
          • Summer Dewdney
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
        • Principal Investigator:
          • Lisa Landrum, MD
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • St Vincent Gynecologic Oncology
        • Principal Investigator:
          • Michael Callahan, MD
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Health Care
        • Principal Investigator:
          • David Bender, MD
        • Contact:
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrea D Jewell, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Baptist Health Lexington
        • Contact:
        • Principal Investigator:
          • Monica Vetter, MD
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
        • Contact:
        • Principal Investigator:
          • Rachel Miller, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Katrina Wade, MD
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • LSUHSC
        • Contact:
          • Maria Stambaugh
          • Phone Number: 504-210-1846
        • Principal Investigator:
          • Amelia Jernigan, MD
    • Maine
      • Scarborough, Maine, United States, 04074
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Greater Baltimore Medical Center
        • Principal Investigator:
          • Fong Liu, MD
        • Contact:
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins Medical Institute
        • Principal Investigator:
          • Stephanie Gaillard, MD
        • Contact:
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore, Inc.
        • Contact:
          • Judy Bosley, RN
          • Phone Number: 410-601-6120
        • Principal Investigator:
          • Pallavi Kumar, MD
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Recruiting
        • Baystate Gynecologic Oncology - Tolosky Center
        • Principal Investigator:
          • Tashanna Myers, MD
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health
        • Contact:
          • Esther Peariso
          • Phone Number: 616-486-0358
        • Principal Investigator:
          • Gregory Gressel, MD
    • Minnesota
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology, P.A. (USOR)
        • Principal Investigator:
          • Jessica Thomes-Pepin, MD
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Nebraska Methodist Hospital
        • Principal Investigator:
          • Brent Tierney, MD
        • Contact:
    • Nevada
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Center of Hope at Renown Medical Center
        • Contact:
          • Shannon Pierpoint
          • Phone Number: 775-327-4673
        • Principal Investigator:
          • Peter Lim, MD
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • John Theurer Cancer Center, University Medical Center, 92 Second Street
        • Principal Investigator:
          • Deena Graham
        • Contact:
          • Phone Number: 616-486-6000
        • Contact:
      • Paramus, New Jersey, United States, 07652
        • Recruiting
        • The Valley Hospital -Luckow Pavilion
        • Contact:
          • Simran Kaur
          • Phone Number: 201-634-5792
        • Principal Investigator:
          • Eleonora Teplinsky, MD
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Holy Name Medical Center
        • Contact:
          • Patty Kiledjian
          • Phone Number: 201-541-6312
        • Principal Investigator:
          • Sharyn Lewin, MD
    • New York
      • Albany, New York, United States, 12206
        • Recruiting
        • New York Oncology Hematology, P.C. (USOR)
        • Contact:
        • Principal Investigator:
          • Heidi E Godoy, MD
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Health-Long Island
        • Contact:
        • Principal Investigator:
          • Bhavana Pothuri, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Monica Prasad-Hayes, MD
      • New York, New York, United States, 10016
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Bhavana Pothuri, MD
      • New York, New York, United States, 12208
      • New York, New York, United States, 11042
        • Recruiting
        • Northwell Health Cancer Institute
        • Contact:
        • Principal Investigator:
          • Veena John, MD
        • Contact:
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC-Chapel Hill
        • Contact:
        • Principal Investigator:
          • Linda Van Le, MD
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
        • Contact:
        • Principal Investigator:
          • Angeles Alvarez Secord, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati
        • Contact:
        • Principal Investigator:
          • Amanda Jackson, MD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University
        • Principal Investigator:
          • Floor Backes, MD
        • Contact:
      • Kettering, Ohio, United States, 45429
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer Center
        • Principal Investigator:
          • Christina Washington, MD
        • Contact:
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Oklahoma Cancer Specialists and Research Institute
        • Contact:
        • Principal Investigator:
          • Michael Gold, MD
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Willamette Valley Cancer Institute and Research Center (USOR)
        • Contact:
        • Principal Investigator:
          • Charles K Anderson, MD
      • Portland, Oregon, United States, 97227
        • Recruiting
        • Northwest Cancer Specialists, P.C. (USOR)
        • Contact:
        • Principal Investigator:
          • Erin A Salinas, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Allegheny Health Network
        • Contact:
        • Principal Investigator:
          • Sarah Crafton, MD
      • Willow Grove, Pennsylvania, United States, 19090
        • Recruiting
        • Sidney Kimmel Cancer Center Asplundh Cancer Pavilion
        • Principal Investigator:
          • Mark Shahin, MD
        • Contact:
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford Gynecologic Oncology, 1309 W. 17th street
        • Principal Investigator:
          • Maria Bell
        • Contact:
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic, PLLC dba West Cancer Center
        • Contact:
        • Sub-Investigator:
          • Michael Ulm, MD
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Oncology, P.A. (USOR)
        • Principal Investigator:
          • Lynne Knowles, MD
        • Contact:
      • Bedford, Texas, United States, 76022
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Texas Oncology-Dallas Presbyterian Hospital (USOR)
        • Principal Investigator:
          • Kristi J McIntyre, MD
        • Contact:
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Oncology (USOR)
        • Contact:
        • Principal Investigator:
          • Noelle G Cloven, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Texas Oncology - San Antonio (USOR)
        • Contact:
        • Principal Investigator:
          • Antonio Santillan-Gomez, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates (USOR)
        • Contact:
        • Principal Investigator:
          • Michael McCollum, MD
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University (VCU)- Massey Comprehensive Cancer Center
        • Principal Investigator:
          • Leslie Randall, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients must be ≥ 18 years of age
  2. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
  4. Patients must be willing to provide an archival tumor tissue block or slides, or must undergo a procedure to obtain a new biopsy using a low-risk, medically routine procedure for IHC confirmation of high FRα expression (reported as "positive") as defined by the Ventana FOLR1 Assay. Patients must be confirmed FRα-high as defined by FRα positivity of ≥ 75% of tumor membrane staining at ≥ 2+ intensity (PS2+) for entry into the study.

  5. Prior BRCA testing on the tumor or prior germline testing is required for eligibility. If not done prior, tumor or germline testing will need to be done before study entry. Somatic and germline BRCA-positive patients must have received prior treatment with a PARPi in maintenance following first-line treatment.

    Note: Local tumor or germline BRCA testing will be acceptable for stratification. If the patient has not been tested, recommend archival tumor samples to be assessed for tissue BRCA. All patients who have received prior first line PARPi maintenance and/or bevacizumab are eligible.

  6. Patients' disease must have relapsed after 1 line (first line) of platinum-based chemotherapy and must be platinum-sensitive defined as progression greater than 6 months from last dose of primary platinum therapy.
  7. Patients must be appropriate for, currently be on, or have completed platinum-based triplet therapy in the second line (recurrent PSOC).

  8. After completion of triplet therapy and before randomization, patients must have received no less than 4 and no greater than 8 cycles of platinum-based triplet therapy in the second line, to include no less than 3 cycles of bevacizumab in combination with platinum-based chemotherapy. If the number of cycles received is less than 6 due to toxicity, this must be documented and toxicity assessed as unlikely related to bevacizumab.

    Note: A minimum of 4 cycles of combination chemotherapy is required. If carboplatin, paclitaxel, gemcitabine, or pegylated liposomal doxorubicin (PLD) is stopped due to toxicity, up to 4 additional cycles of single agent in combination with bevacizumab is acceptable if appropriately documented.

  9. After completion of triplet therapy and before randomization: In the case of interval secondary cytoreductive surgery, patients are permitted to have received only 2 cycles of bevacizumab if given in combination with the last 3 cycles of platinum-based triplet therapy in the second line. In the case of primary cytoreductive surgery before secondline platinum-based triplet therapy, patients must have received no fewer than 3 cycles of bevacizumab in combination with platinum-based chemotherapy after their surgery and before randomization.
  10. Patients either will receive (per investigator's choice), must be receiving, or have received paclitaxel, gemcitabine, or pegylated liposomal doxorubicin as the partner drug to platinum-based triplet therapy in the second line.
  11. After completion of triplet therapy and before randomization, patients must have achieved a CR, PR, or SD, per the investigator, in the second line to be eligible for randomization into the study population. All patients will have CT or MRI scans and CA-125 measurements at least 3 weeks but no more than 8 weeks after their last planned dose of triplet therapy and before randomization.
  12. Patients must be randomized no later than 8 weeks from the last dose of platinum-based triplet therapy in the second line.

  13. After completion of triplet therapy and before randomization, patients must meet one of the following criteria:

    1. Have at least 1 lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (radiologically measured by the investigator), and determined by the investigator to either have SD or a PR to their treatment; or
    2. Have persistently elevated CA-125 without measurable disease and determined by the investigator to have either SD or a PR to their treatment; or
    3. Have clinically no evidence of disease by both radiographic interpretation by the investigator and normalization of their CA-125, determined to be a CR.
  14. Patients must have stabilized or recovered (to Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia).
  15. Patients must have completed any major surgery at least 4 weeks before the first dose of study treatment (either Run-In or maintenance therapy) and have recovered or stabilized from the side effects of prior surgery before the first dose of treatment on study.

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

    1. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/μL) without granulocyte colony-stimulating factor in the prior 10 days or long-acting white blood cell (WBC) growth factors in the prior 10 days of C1D1 of maintenance treatment.
    2. Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the prior 10 days of C1D1 of maintenance treatment
    3. Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 10 days of C1D1 of maintenance treatment
    4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
    5. Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN
    6. Serum bilirubin ≤ 1.5 × ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 × ULN)
    7. Serum albumin ≥ 2 g/dL
  17. Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
  18. Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method(s) (as defined in Section 5.10.7) while on study medication and for at least 3 months after the last dose.
  19. FCBP must have a negative pregnancy test within 4 days before the first dose of therapy.

Exclusion Criteria:

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

  2. More than one line of prior chemotherapy before current/planned triplet therapy. Lines of prior anticancer therapy are counted with the following considerations:

    1. 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.
    2. Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the preceding line of therapy (ie, not counted independently).
    3. Change due to toxicity will be considered part of the proceeding line of therapy.
  3. Patients with PD while on or following platinum-based triplet therapy
  4. After completion of triplet therapy and prior to randomization: Patients who receive an intervening dose of bevacizumab after the last dose of triplet therapy before randomization
  5. Patients with prior wide-field radiotherapy affecting at least 20% of the bone marrow
  6. Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
  7. 7. 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

  8. 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. HIV infection
    3. Active cytomegalovirus infection
    4. Any other concurrent infectious disease requiring intravenous (IV) antibiotics within 2 weeks before the first dose of maintenance therapy Note: Testing at screening is not required for the above infections unless clinically indicated.
  9. Patients with a history of multiple sclerosis or other demyelinating diseases and/or Lambert-Eaton syndrome (paraneoplastic syndrome)

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

    1. Myocardial infarction ≤ 6 months prior to C1D1 of maintenance treatment
    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
  11. Patients with a history of hemorrhagic or ischemic stroke within 6 months before enrollment
  12. Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
  13. Patients with a previous clinical diagnosis of noninfectious interstitial lung disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic agent used in the treatment of their malignancy that has resolved per investigator or resolution of the radiologic findings)
  14. History of bowel obstruction (including sub-occlusive disease) related to underlying disease within 6 months before the start of maintenance study treatment (triplet therapy for Run-In patients).
  15. History of abdominal fistula or gastrointestinal perforation
  16. Intra-abdominal abscess, evidence of rectosigmoid involvement by pelvic examination, bowel involvement on CT scan, or clinical symptoms of bowel obstruction within 4 weeks prior to randomization (or within 4 weeks prior to starting triplet therapy for Run- In patients)
  17. Clinically significant proteinuria: urine-protein to creatinine (UPC) ratio ≥ 1.0 or urine dipstick result ≥ 2+; patients with UPC ratio ≥ 1.0 or ≥ 2+ proteinuria should undergo 24-hour urine collection and must show result ≤ 1 g of protein in a 24-hour period.
  18. History of Grade 4 thromboembolic events
  19. Patients not appropriate for bevacizumab 15 mg/kg dosing at the start of maintenance therapy as per the treating physician
  20. Patients requiring use of folate-containing supplements (eg, folate deficiency)
  21. Patients with prior hypersensitivity to monoclonal antibodies (mAbs)
  22. Women who are pregnant or breastfeeding
  23. Patients who received prior treatment with MIRV or other FRα-targeting agents
  24. Patients with untreated or symptomatic central nervous system metastases

  25. Patients with a history of other malignancy within 3 years prior to signing study consent

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

  26. Prior known hypersensitivity reactions to study drugs or any of their excipients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Mirvetuximab Soravtansine (MIRV) plus Bevacizumab
Drug: Mirvetuximab soravtansine plus Bevacizumab
Participants will receive MIRV 6.0 mg/kg adjusted ideal body weight (AIBW) plus Bevacizumab 15mg/kg every 3 weeks
Other Names:
  • MIRV
Active Comparator: Arm 2
Bevacizumab monotherapy
Drug: Bevacizumab
Participants will receive Bevacizumab 15mg/kg every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Progression-free survival (PFS)
Time Frame: Up to 4 years
Progression-free survival defined as the time from date of randomization until investigator-assessed progressive disease (PD) or death, whichever occurs first.
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess Overall survival (OS)
Time Frame: Up to 7 years
Overall survival (OS), defined as the time from randomization to death
Up to 7 years
Assess Safety and tolerability
Time Frame: Up to 7 years
Adverse events (AEs) will be evaluated according to the NCI CTCAE v5.0
Up to 7 years
Assess second disease progression (PFS2)
Time Frame: Up to 7 years
Second disease progression (PFS2)defined as the time from date of randomization until second disease progression or death, whichever occurs first
Up to 7 years
Assess Objective Response Rate (ORR)
Time Frame: Up to 7 years
Objective response includes best response of complete response (CR) or partial response (PR).
Up to 7 years
CA-125 response
Time Frame: Up to 7 years
Serum CA-125 response determined using the GCIG criteria
Up to 7 years
Assess Duration of response (DOR)
Time Frame: Up to 7 years
Measured only in patients who achieved a confirmed best overall response of CR or PR upon completion of platinum-based combination chemotherapy with bevacizumab (triplet therapy)
Up to 7 years
Assess Disease-free survival (DFS)
Time Frame: Up to 7 years
Measured only in patients who have no measurable disease per RECIST v1.1 at randomization
Up to 7 years
Patient-reported outcome health-related quality of life (HRQoL) of disease-related symptoms using the NCCN-FACT Ovarian Symptom Index (NFOSI-18) DRS-P (disease-related symptom subscale - physical).
Time Frame: Up to 7 years
A questionnaire assessing the health of patients with ovarian cancer.
Up to 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmunoGen, Inc.

Collaborators

GOG Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

June 30, 2022

First Submitted That Met QC Criteria

June 30, 2022

First Posted (Actual)

July 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMGN853-0421

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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Locations

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