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

Ovarian Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05445778
• Other study ID #: IMGN853-0421
• Status: Recruiting
• Phase: Phase 3
• Start date: December 27, 2022
• Est. completion date: April 2029

Study information

• Verified date: May 2024
• Source: ImmunoGen, Inc.
• Contact: ImmunoGen, Inc.
• Phone: 781-895-0600
• Email: medicalinformation[@]immunogen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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. .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 418
• Est. completion date: April 2029
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 FRa expression (reported as "positive") as defined by the Ventana FOLR1 Assay. Patients must be confirmed FRa-high as defined by FRa 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 FRa-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

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Hypersensitivity
• Ovarian Cancer
• Peritoneal Cancer
• Peritoneal Neoplasms

Intervention

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
• Bevacizumab
Participants will receive Bevacizumab 15mg/kg every 3 weeks

Locations

Country	Name	City	State
Australia	Grampians Health Service	Ballarat	Victoria
Australia	Cabrini Health	Brighton	Victoria
Australia	Monash Health	Clayton	Victoria
Australia	Peter Maccallum Cancer Centre	Melbourne	Victoria
Australia	Epworth Health	Richmond	Victoria
Australia	Gold Coast University Hospital	Southport	Queensland
Australia	Bendat Family Comprehensive Cancer Centre St John of God - Subiaco Hospital	Subiaco
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	Imeldaziekenhuis, Apotheek Klinische Studies, Imeldalaan 9 Centraal Magazjin	Bonheiden
Belgium	Cliniques Universitaires St-Luc Woluwe-Saint-Lambert	Brussel
Belgium	GHDC Grand Hôpital de Charleroi, Site Notre-Dame, Grand Rue 3	Charleroi
Belgium	AZ Sint Lucas Gent, Groenebriel 1	Gent
Belgium	UZ Leuven, Apotheek Klinische studies, Herestraat, 49	Leuven
Belgium	CHU UCL Namur - Site Sainte-Elisabeth, Route (Road) 471 Place Louise Godin 15, Oncology Day Hospital, 3rd Floor	Namur
Belgium	AZ Delta apotheek, Tav Klinische studies, Kwadestraat 78	Roeselare
Canada	Tom Baker Cancer Centre, Alberta Health Services	Calgary	Alberta
Canada	University of Alberta - Cross Cancer Institute (CCI)	Edmonton	Alberta
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Kinston Health Sciences Center - KGH Site	Kingston	Ontario
Canada	Centre Hospitalier de L'Universite de Montreal - Centre de Recherche	Montreal	Quebec
Canada	McGill University Health Centre	Montreal	Quebec
Canada	Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)	Montreal	Quebec
Canada	The Ottawa Hospital Cancer Centre	Ottawa	Ontario
Canada	CHUS - Hôpital Fleurimont	Sherbrooke	Quebec
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	BC Cancer - Vancouver	Vancouver	British Columbia
Czechia	University Hospital Brno	Brno
Czechia	Nemocnice AGEL Nový Jicín a.s.	Nový Jicín
Czechia	University Hospital Ostrava	Ostrava Poruba
Czechia	General University Hospital in Prague	Prague
Israel	Carmel Medical Centre	Haifa
Israel	Wolfson Medical Centre	Holon
Israel	Hadassah Medical Ctr. Ein Kerem. Sharett Institute of oncology	Jerusalem
Israel	Shaare Zedek Medical Centre	Jerusalem
Israel	Meir Medical Centre	Kefar Sava
Israel	Rabin Medical Centre	Petah Tikva
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv Yaffo
Italy	Policlinico S. Orsola-Malpighi	Bologna
Italy	AOU Careggi	Firenze
Italy	ASST Ospedale Alessandro Manzoni	Lecco
Italy	Azienda USL Toscana Nord Ovest Ospedale San Luca	Lucca
Italy	IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano
Italy	IRCCS San Raffaele	Milano
Italy	Ospedale di Mirano	Mirano
Italy	AOU di Parma	Parma
Italy	AUSL Piacenza Ospedale Guglielmo da Saliceto	Piacenza
Italy	Nuovo Ospedale di Prato - Santo Stefano	Prato
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome
Korea, Republic of	Keimyung Dongsan University Hospital	Daegu
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi-do
Korea, Republic of	CHA University - Bundang CHA General Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Philippines	The Medical City -Ortigas	Pasig	Metro Manila
Philippines	East Avenue Medical Centre	Quezon City
Philippines	Cardinal Santos Medical Center	San Juan	Metro Manila
Spain	Hospital Clinic de Barcelona (Hospital Clinic i Provincial)	Barcelona
Spain	Hospital Universitario Vall d'Hebron, CT Pharm General Building-Floor B, Passeig Vall d'Hebron	Barcelona
Spain	Instituto Catalán de Oncologia, 199-203 Av Gra Via CT Pharmacy, Hospital Duran i Reynals	Barcelona
Spain	Hospital Universitario de A Coruña (CHUAC)	Coruña
Spain	ICO-Hospital Universitario de Girona	Girona
Spain	Clínica Universidad de Navarra	Madrid
Spain	Hospital La Paz CT Pharmacy, 261 Paseo Castellana, North Building Ground Floor	Madrid
Spain	Clinica Universitaria Navarra Pamplona	Pamplona
Spain	Hospital Clinico Universitario de Valencia	Valencia
United Kingdom	Cheltenham General Hospital	Cheltenham
United Kingdom	The Royal Marsden NHS Foundation Trust	Fulham	London
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	Mount Vernon Cancer Centre East and North Hertfordshire NHS Trust	Northwood
United Kingdom	Southampton University NHS Trust	Southampton
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey
United Kingdom	Singleton Hospital	Swansea
United States	New York Oncology Hematology, P.C. (USOR)	Albany	New York
United States	Northside Hospital	Atlanta	Georgia
United States	Texas Oncology, P.A. (USOR)	Austin	Texas
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	Johns Hopkins Medical Institute	Baltimore	Maryland
United States	Sinai Hospital of Baltimore, Inc.	Baltimore	Maryland
United States	Texas Oncology - DFWW (USOR)	Bedford	Texas
United States	UNC-Chapel Hill	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University Medical Center, 1725 West Harrison Street	Chicago	Illinois
United States	University of Chicago Medicine, 5841 S Maryland Ave, MC 2115	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Ohio State University	Columbus	Ohio
United States	John Muir Health	Concord	California
United States	Texas Oncology-Dallas Presbyterian Hospital (USOR)	Dallas	Texas
United States	Duke Cancer Center	Durham	North Carolina
United States	Willamette Valley Cancer Institute and Research Center (USOR)	Eugene	Oregon
United States	Broward Health Medical Center	Fort Lauderdale	Florida
United States	Regional Cancer Center/ Florida Gynecologic Oncology	Fort Myers	Florida
United States	Texas Oncology (USOR)	Fort Worth	Texas
United States	The West Clinic, PLLC dba West Cancer Center	Germantown	Tennessee
United States	Corewell Health	Grand Rapids	Michigan
United States	John Theurer Cancer Center, University Medical Center, 92 Second Street	Hackensack	New Jersey
United States	Indiana University	Indianapolis	Indiana
United States	St Vincent Gynecologic Oncology	Indianapolis	Indiana
United States	University of Iowa Health Care	Iowa City	Iowa
United States	City of Hope	Irvine	California
United States	Kaiser Permanente Irvine Medical Center, 6650 Alton Pkwy	Irvine	California
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	Kettering Health	Kettering	Ohio
United States	UC San Diego Health - Moores Cancer Center	La Jolla	California
United States	Dartmouth Hitchcock Medical, One Medical Center Drive	Lebanon	New Hampshire
United States	Baptist Health Lexington	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	Kaiser Permanente Los Angeles Medical Center, 4950 Sunset Blvd., 6th Floor	Los Angeles	California
United States	Minnesota Oncology Hematology, P.A. (USOR)	Maplewood	Minnesota
United States	Mount Sinai Comprehensive Cancer Center	Miami	Florida
United States	Perlmutter Cancer Center at NYU Langone Health-Long Island	Mineola	New York
United States	USA Mitchell Cancer Institute	Mobile	Alabama
United States	LSUHSC	New Orleans	Louisiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Mount Sinai Hospital	New York	New York
United States	Northwell Health Cancer Institute	New York	New York
United States	Perlmutter Cancer Center at NYU Langone Health	New York	New York
United States	Womens Cancer Care Associates	New York	New York
United States	Virginia Oncology Associates (USOR)	Norfolk	Virginia
United States	OU Health Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	UCI Health- Chao Family Comprehensive Cancer Center	Orange	California
United States	Stanford University	Palo Alto	California
United States	The Valley Hospital -Luckow Pavilion	Paramus	New Jersey
United States	Honor Health Cancer Care, Biltmore, 2222 E. Highland Ave, #400	Phoenix	Arizona
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	Northwest Cancer Specialists, P.C. (USOR)	Portland	Oregon
United States	OHSU Center for Health & Healing, Building 2 (CHH2), 3485 S Bond Ave	Portland	Oregon
United States	Center of Hope at Renown Medical Center	Reno	Nevada
United States	Virginia Commonwealth University (VCU)- Massey Comprehensive Cancer Center	Richmond	Virginia
United States	Kaiser Permanente Riverside Medical Center, 10800 Magnolia Ave	Riverside	California
United States	Texas Oncology - San Antonio (USOR)	San Antonio	Texas
United States	Kaiser Permanente Zion Medical Center, 4647 Zion Ave	San Diego	California
United States	Kaiser Permanente San Marcos Medical Offices, 400 Craven Road	San Marcos	California
United States	Sarasota Memorial Health Care System	Sarasota	Florida
United States	Maine Medical Center	Scarborough	Maine
United States	Sanford Gynecologic Oncology, 1309 W. 17th street	Sioux Falls	South Dakota
United States	Baystate Gynecologic Oncology - Tolosky Center	Springfield	Massachusetts
United States	Olive View UCLA Medical Center Inpatient Pharmacy, 14445 Olive View Dr, Rm 1C101	Sylmar	California
United States	Holy Name Medical Center	Teaneck	New Jersey
United States	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	Sidney Kimmel Cancer Center Asplundh Cancer Pavilion	Willow Grove	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
ImmunoGen, Inc.	GOG Foundation

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czechia,  Israel,  Italy,  Korea, Republic of,  Philippines,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess Progression-free survival (PFS)	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	Assess Overall survival (OS)	Overall survival (OS), defined as the time from randomization to death	Up to 7 years
Secondary	Assess Safety and tolerability	Adverse events (AEs) will be evaluated according to the NCI CTCAE v5.0	Up to 7 years
Secondary	Assess second disease progression (PFS2)	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
Secondary	Assess Objective Response Rate (ORR)	Objective response includes best response of complete response (CR) or partial response (PR).	Up to 7 years
Secondary	Assess Duration of response (DOR)	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
Secondary	Assess Disease-free survival (DFS)	Measured only in patients who have no measurable disease per RECIST v1.1 at randomization	Up to 7 years
Secondary	CA-125 response	Serum CA-125 response determined using the GCIG criteria	Up to 7 years
Secondary	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).	A questionnaire assessing the health of patients with ovarian cancer.	Up to 7 years