Ovarian Cancer Clinical Trial

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

Summary

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

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Full 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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View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients must be ≥ 18 years of age
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Patients must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.
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.

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.

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.
Patients must be appropriate for, currently be on, or have completed platinum-based triplet therapy in the second line (recurrent PSOC).

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.

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.
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.
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.
Patients must be randomized no later than 8 weeks from the last dose of platinum-based triplet therapy in the second line.

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

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
Have persistently elevated CA-125 without measurable disease and determined by the investigator to have either SD or a PR to their treatment; or
Have clinically no evidence of disease by both radiographic interpretation by the investigator and normalization of their CA-125, determined to be a CR.
Patients must have stabilized or recovered (to Grade 1 or baseline) from all prior therapy-related toxicities (except alopecia).
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.

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

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.
Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the prior 10 days of C1D1 of maintenance treatment
Hemoglobin ≥ 9.0 g/dL without packed red blood cell (PRBC) transfusion in the prior 10 days of C1D1 of maintenance treatment
Serum creatinine ≤ 1.5 × upper limit of normal (ULN)
Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN
Serum bilirubin ≤ 1.5 × ULN (patients with documented diagnosis of Gilbert syndrome are eligible if total bilirubin < 3.0 × ULN)
Serum albumin ≥ 2 g/dL
Patients must be willing and able to sign the informed consent form (ICF) and to adhere to the protocol requirements.
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.
FCBP must have a negative pregnancy test within 4 days before the first dose of therapy.

Exclusion Criteria:

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

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

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.
Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the preceding line of therapy (ie, not counted independently).
Change due to toxicity will be considered part of the proceeding line of therapy.
Patients with PD while on or following platinum-based triplet therapy
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
Patients with prior wide-field radiotherapy affecting at least 20% of the bone marrow
Patients with > Grade 1 peripheral neuropathy per Common Terminology Criteria for Adverse Events (CTCAE)
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

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

Active hepatitis B or C infection (whether or not on active antiviral therapy)
HIV infection
Active cytomegalovirus infection
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.
Patients with a history of multiple sclerosis or other demyelinating diseases and/or Lambert-Eaton syndrome (paraneoplastic syndrome)

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

Myocardial infarction ≤ 6 months prior to C1D1 of maintenance treatment
Unstable angina pectoris
Uncontrolled congestive heart failure (New York Heart Association > class II)
Uncontrolled ≥ Grade 3 hypertension (per CTCAE)
Uncontrolled cardiac arrhythmias
Patients with a history of hemorrhagic or ischemic stroke within 6 months before enrollment
Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)
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)
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).
History of abdominal fistula or gastrointestinal perforation
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)
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.
History of Grade 4 thromboembolic events
Patients not appropriate for bevacizumab 15 mg/kg dosing at the start of maintenance therapy as per the treating physician
Patients requiring use of folate-containing supplements (eg, folate deficiency)
Patients with prior hypersensitivity to monoclonal antibodies (mAbs)
Women who are pregnant or breastfeeding
Patients who received prior treatment with MIRV or other FRα-targeting agents
Patients with untreated or symptomatic central nervous system metastases

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.

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

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

418

Study ID:

NCT05445778

Recruitment Status:

Recruiting

Sponsor:

ImmunoGen, Inc.

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There are 48 Locations for this study

See Locations Near You

USA Mitchell Cancer Institute
Mobile Alabama, 36604, United States More Info
Stefanie White
Contact
251-445-9834
Jennifer Scalici,, MD
Principal Investigator
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States More Info
Ramez Eskander, MD
Contact
858-822-6146
Ramez Eskander, MD
Principal Investigator
Regional Cancer Center/ Florida Gynecologic Oncology
Fort Myers Florida, 33905, United States More Info
Julia Malfeld
Contact
239-343-9660
[email protected]
Edward Grendys, MD
Principal Investigator
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States More Info
Poonam Neki
Contact
[email protected]
Lauren Hand, MD
Principal Investigator
Sarasota Memorial Health Care System
Sarasota Florida, 34239, United States More Info
Angele Price
Contact
941-917-3614
[email protected]
Beverly Long, MD
Principal Investigator
Northside Hospital
Atlanta Georgia, 30342, United States More Info
Meaghan Tenney, MD
Principal Investigator
Kapi'olani Medical Center for Women and Children
Honolulu Hawaii, 96826, United States More Info
Robyn Mors
Contact
808-983-8749
[email protected]
Michael Carney, MD
Principal Investigator
Indiana University
Indianapolis Indiana, 46202, United States More Info
Liz Crist
Contact
[email protected]
Lisa Landrum
Principal Investigator
St Vincent Gynecologic Oncology
Indianapolis Indiana, 46260, United States More Info
Cynthia Cruz, CCRP
Contact
317-415-6747
[email protected]
Michael Callahan, MD
Principal Investigator
University of Iowa Hospitals & Clinics
Iowa City Iowa, 52242, United States More Info
Jessica Landgrebe, MD
Contact
319-356-2015
[email protected]
David Bender, MD
Principal Investigator
University of Kansas Cancer Center
Westwood Kansas, 66205, United States More Info
Andrea D Jewell
Principal Investigator
Baptist Health Lexington
Lexington Kentucky, 40503, United States More Info
Lauren Higgins
Contact
859-260-6464
[email protected]
Monica Vetter, MD
Principal Investigator
LSUHSC
New Orleans Louisiana, 70112, United States More Info
Maria Stambaugh
Contact
504-210-1846
Amelia Jernigan, MD
Principal Investigator
Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States More Info
Nicole Perry
Contact
504-703-2652
[email protected]
Katrina Wade
Principal Investigator
Maine Medical Center
Scarborough Maine, 04074, United States More Info
Leslie Bradford, MD
Principal Investigator
Greater Baltimore Medical Center
Baltimore Maryland, 21204, United States More Info
Laura M Cucci
Contact
443-849-3122
[email protected]
Fong Liu, MD
Principal Investigator
Sinai Hospital of Baltimore, Inc.
Baltimore Maryland, 21215, United States More Info
Judy Bosley, RN
Contact
410-601-6120
Pallavi Kumar, MD
Principal Investigator
Baystate Gynecologic Oncology - Tolosky Center
Springfield Massachusetts, 01107, United States More Info
Tashanna Myers
Principal Investigator
Minnesota Oncology Hematology, P.A. (USOR)
Maplewood Minnesota, 55109, United States More Info
Jinan Ali
Contact
[email protected]
Thomes Pepin
Principal Investigator
Center of Hope at Renown Medical Center
Reno Nevada, 89511, United States More Info
Shannon Pierpoint
Contact
775-327-4673
Peter Lim
Principal Investigator
John Theurer Cancer Center
Hackensack New Jersey, 07601, United States More Info
Lauren Wiest
Contact
551-996-5834
[email protected]
Donna McNamara, MD
Principal Investigator
The Valley Hospital -Luckow Pavilion
Paramus New Jersey, 07652, United States More Info
Simran Kaur
Contact
201-634-5792
Eleonora Teplinsky, MD
Principal Investigator
Holy Name Medical Center
Teaneck New Jersey, 07666, United States More Info
Patty Kiledjian
Contact
201-541-6312
Sharyn Lewin, MD
Principal Investigator
New York Oncology Hematology, P.C. (USOR)
Albany New York, 12206, United States More Info
Josephine Faruol
Contact
[email protected]
Heidi E Godoy
Principal Investigator
Perlmutter Cancer Center at NYU Langone Health-Long Island
Mineola New York, 11501, United States More Info
Bhavana Pothuri, MD
Principal Investigator
Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States More Info
Bhavana Pothuri, MD
Principal Investigator
Northwell Health Cancer Institute
New York New York, 11042, United States More Info
Mary Agnes Templeton
Contact
516-734-8979
[email protected]
Charline Watts
Contact
516- 734- 8496
[email protected]
Mark Messing
Sub-Investigator
Womens Cancer Care Associates
New York New York, 12208, United States More Info
NICOLINA SURIANO
Contact
518-458-1390
[email protected]
JOYCE BARLIN
Principal Investigator
UNC-Chapel Hill
Chapel Hill North Carolina, 27514, United States More Info
Jada Jones
Contact
919-918-1815
[email protected]
Linda Van Le, MD
Principal Investigator
Duke Cancer Center
Durham North Carolina, 27710, United States More Info
Jennifer Mewshaw
Contact
919-684-3780
[email protected]
Angeles Secord
Principal Investigator
Kettering Health
Kettering Ohio, 45429, United States More Info
Daniel Geyer
Contact
937-395-6017
[email protected]
Thomas Reid, MD
Principal Investigator
Oklahoma Cancer Specialists and Research Institute
Tulsa Oklahoma, 74146, United States More Info
Michael Gold, MD
Contact
918-505-3200
Willamette Valley Cancer Institute and Research Center (USOR)
Eugene Oregon, 97401, United States More Info
Jeanne Schaffer
Contact
[email protected]
Charles K Anderson
Principal Investigator
Northwest Cancer Specialists, P.C. (USOR)
Portland Oregon, 97227, United States More Info
Jennifer Thompson, CRC,RN
Contact
[email protected]
Erin A Salinas
Principal Investigator
Allegheny Health Network
Pittsburgh Pennsylvania, 15224, United States More Info
Madeline Rigatti
Contact
[email protected]
Sarah Crafton
Principal Investigator
The West Clinic, PLLC dba West Cancer Center
Germantown Tennessee, 38138, United States More Info
Robin Patterson
Contact
901-683-0055
[email protected]
Michael Ulm
Sub-Investigator
Texas Oncology, P.A. (USOR)
Austin Texas, 78731, United States More Info
Marian Heaven
Contact
[email protected]
Lynne Knowles
Principal Investigator
Texas Oncology - DFWW (USOR)
Bedford Texas, 76022, United States More Info
Deborah Arant-Daigle
Contact
[email protected]
Mark J Messing
Principal Investigator
Texas Oncology-Dallas Presbyterian Hospital (USOR)
Dallas Texas, 75231, United States More Info
Nancy Jones
Contact
[email protected]
Kristi J McIntyre
Principal Investigator
Texas Oncology (USOR)
Fort Worth Texas, 76104, United States More Info
Lynora (Nori) Sullivan
Contact
[email protected]
Noelle G Cloven
Principal Investigator
Texas Oncology - San Antonio (USOR)
San Antonio Texas, 78240, United States More Info
Debora E Lind
Contact
[email protected]
Antonio Santillan-Gomez
Principal Investigator
University of Virginia
Charlottesville Virginia, 22908, United States More Info
Hannah Snow
Contact
4349824110/[email protected]
Linda Duska
Principal Investigator
Virginia Oncology Associates (USOR)
Norfolk Virginia, 23502, United States More Info
Jenny Marks
Contact
[email protected]
McCollum, MD
Principal Investigator
Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Melanie Hamilton
Contact
804-628-7130
[email protected]
Leslie Randall
Principal Investigator
Tom Baker Cancer Centre, Alberta Health Services
Calgary Alberta, T2N 4, Canada More Info
Prafull Ghatage
Principal Investigator
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada More Info
Nidhi Kumar-Tyagi
Contact
905-387-9495
Nidhi Kumar-Tyagi, Dr.
Principal Investigator
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Amit Oza, Dr.
Principal Investigator
Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
Montreal Quebec, H1T 2, Canada More Info
Samara Bloom
Contact
514-252-3400
[email protected]
Lara De Guerke
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 3

Estimated Enrollment:

418

Study ID:

NCT05445778

Recruitment Status:

Recruiting

Sponsor:


ImmunoGen, Inc.

How clear is this clinincal trial information?

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