IMagyn050: A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Study Details
Study Description
Brief Summary
This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab intravenous (IV) infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab for a total of 22 cycles of atezolizumab and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and atezolizumab for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles. |
Drug: Paclitaxel
Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle
Drug: Carboplatin
Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles
Drug: Atezolizumab
Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
Drug: Bevacizumab
Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
|
Placebo Comparator: Placebo With Paclitaxel, Carboplatin and Bevacizumab Participants in the primary tumor-reductive surgery group will receive paclitaxel, carboplatin, atezolizumab placebo IV infusion on Day 1 of each 21-day cycle for a total of 6 cycles, and bevacizumab IV infusion starting with Cycle 2 for a total of 5 cycles, followed by maintenance therapy bevacizumab with atezolizumab placebo for a total of 22 cycles of atezolizumab placebo and 21 cycles of bevacizumab. Participants in the neoadjuvant therapy group will receive paclitaxel, carboplatin and placebo for 6 cycles and bevacizumab for 4 cycles. Interval surgery will occur between cycles 3 and 4. Each cycle is 21 days long. After 6 cycles, participants will start maintenance therapy of bevacizumab and placebo for additional 16 cycles. |
Drug: Paclitaxel
Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle
Drug: Carboplatin
Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles
Drug: Bevacizumab
Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
Drug: Atezolizumab Placebo
Placebo matching to atezolizumab on Day 1 of each 21-day cycle
|
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival (PFS) Assessed by Investigator as Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) - Intent-to-Treat (ITT) Population [From randomization until disease progression or death from any cause (up to approximately 55 months)]
- PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation [From randomization until disease progression or death from any cause (up to approximately 55 months)]
- Overall Survival - ITT Population [From randomization up to death from any cause (up to approximately 60 months)]
- Overall Survival - PD-L1-Positive Subpopulation [From randomization up to death from any cause (up to approximately 60 months)]
Secondary Outcome Measures
- Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group [From randomization until disease progression or death from any cause (up to approximately 55 months)]
- Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group [From the date of first occurrence of a confirmed complete or partial response until disease progression or death from any cause (up to approximately 55 months)]
- Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain or Bloating - Neoadjuvant Group [From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 60 months)]
Clinically-meaningful improvement in patient-reported abdominal pain or bloating will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Ovarian Cancer Module 28 (EORTC QLQ-OV28) Abdominal/Gastrointestinal Symptom Scale (Items 31 and 31).
- Percentage of Participants who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group [From randomization to the end of treatment/discontinuation (up to approximately 70 weeks), and during follow-up period (up to approximately 60 months)]
Clinically-meaningful improvement in patient-reported function and HRQoL will be assessed using European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).
- Percentage of Participants who Achieve a Clinically-Meaningful Improvement, Remain Stable or Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group [From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months)]
Clinically-meaningful improvement in patient-reported function and HRQoL will be assessed using EORTC QLQ-C30.
- Percentage of Participants With Adverse Events [From randomization up to 90 days after last dose of study treatment or until initiation of new anti-cancer therapy (up to approximately 82 weeks)]
- Maximum Serum Concentration (Cmax) of Atezolizumab [Pre-infusion (0 hour [hr]), 30 minutes (min) after end of infusion (EOI) on Cycle 1 Day 1(Cycle length=21 days) up to approximately 82 weeks (detailed timeframe is provided in outcome measure description)]
Primary surgery group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4, 8, 16 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 66 weeks); >/=90 days after last dose (up to approximately 78 weeks) Neoadjuvant therapy group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 70 weeks); >/= 90 days after last dose (up to approximately 82 weeks)
- Minimum Serum Concentration (Cmin) of Atezolizumab [Pre-infusion (0 hr), 30 min after EOI on Cycle 1 Day 1(Cycle length=21 days) up to approximately 82 weeks (detailed timeframe is provided in outcome measure description)]
Primary surgery group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4, 8, 16 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 66 weeks); >/= 90 days after last dose (up to approximately 78 weeks) Neoadjuvant therapy group: Pre-infusion (0 hr), 30 min after EOI (infusion duration=60 min) on Day 1 of Cycles 1 and 3; pre-infusion (0 hr) on Day 1 of Cycles 2, 4 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 70 weeks); >/= 90 days after last dose (up to approximately 82 weeks)
- Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [Pre-infusion (0 hr) on Cycle 1 Day 1(Cycle length=21 days) up to approximately 82 weeks (detailed timeframe is provided in outcome measure description)]
Primary surgery group: Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 66 weeks); >/= 90 days after last dose (up to approximately 78 weeks) Neoadjuvant therapy group: Pre-infusion (0 hr) on Day 1 of Cycles 1, 2, 3, 4 (each cycle=21 days); end of treatment/discontinuation visit (up to approximately 70 weeks); >/= 90 days after last dose (up to approximately 82 weeks)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer
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Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
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Life expectancy greater than (>) 12 weeks
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For participants who receive therapeutic anticoagulation: stable anticoagulant regimen
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Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in paraffin blocks (preferred) or at least 20 unstained slides (for detailed tissue requirements at screening)
Exclusion Criteria:
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Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential)
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Have recurrent invasive epithelial ovarian, fallopian tube, or primary peritoneal cancer that was treated only with surgery (example [e.g.], participants with Stage IA or Stage IB epithelial ovarian or fallopian tube cancers)
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Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors)
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Received prior radiotherapy to any portion of the abdominal cavity or pelvis
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Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer
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Received any biological and/or targeted therapy (including but not limited to vaccines, antibodies, tyrosine kinase inhibitors) or hormonal therapy for management and/or treatment of epithelial ovarian or peritoneal primary cancer
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Have synchronous primary endometrial cancer
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Have a prior history of primary endometrial cancer, except: Stage IA cancer; superficial myometrial invasion, without lymphovascular invasion; grade less than (<) 3 or poorly differentiated subtypes, and this includes papillary serous, clear cell or other International Federation of Gynecological Oncologists (FIGO) Grade 3 lesions
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With the exception of non-melanoma skin cancer and other specific malignancies as noted above, other invasive malignancies with any evidence of other cancers present within the last 5 years or previous cancer treatment that contraindicates this protocol therapy
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Have a known hypersensitivity or allergy to biopharmaceutical agents produced in Chinese hamster ovary cells or any component of the atezolizumab and/or bevacizumab formulations
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Undergo major surgical procedure within 28 days prior to first bevacizumab dose, or anticipation of the need for a major surgical procedure during the course of the study except participants who receive NACT and will need interval surgery. This may include but is not limited to laparotomy.
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Have prior allogeneic bone marrow transplantation or solid organ transplant
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Have any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results
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Have any approved or investigational anti-cancer therapy, including chemotherapy or hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives
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Are administered treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent
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Have core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab
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Have known sensitivity to any component of bevacizumab
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Have known sensitivity to any component of paclitaxel
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Current treatment with anti-viral therapy for hepatitis B virus (HBV)
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History of leptomeningeal disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | St. Joseph'S Hospital & Medical Center | Phoenix | Arizona | United States | 85013 |
2 | Arizona Oncology Associates, PC - HAL; Arizona Oncology Associates, PC - HAL | Scottsdale | Arizona | United States | 85258 |
3 | Arizona Oncology - HOPE Wilmot | Tucson | Arizona | United States | 85710 |
4 | Moores Cancer Center at UC San Diego Health | La Jolla | California | United States | 92093 |
5 | LAC + USC Medical Center | Los Angeles | California | United States | 90033 |
6 | UCLA - School of Medicine | Los Angeles | California | United States | 90095 |
7 | Kaiser Permanente - Oakland | Oakland | California | United States | 94611 |
8 | The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange | Orange | California | United States | 92868 |
9 | UC Irvine Medical Center | Orange | California | United States | 92868 |
10 | Stanford University | Palo Alto | California | United States | 94305 |
11 | Kaiser Permanente - Sacramento | Roseville | California | United States | 95661 |
12 | Southern California Kaiser Permanente | San Diego | California | United States | 92108 |
13 | California Pacific Medical Center Research Institute | San Francisco | California | United States | 94115 |
14 | K. Permanente - San Fransisco | San Francisco | California | United States | 94115 |
15 | University of California San Francisco Cancer Center | San Francisco | California | United States | 94158 |
16 | Kaiser Permanente - Santa Clara | Santa Clara | California | United States | 95051 |
17 | Olive View/Ucla Medical Center | Sylmar | California | United States | 91342 |
18 | Kaiser Permanente - Vallejo | Vallejo | California | United States | 94589 |
19 | Kaiser Permanente - Walnut Creek | Walnut Creek | California | United States | 94596 |
20 | University of Colorado Hospital - Anschutz Cancer Pavilion | Aurora | Colorado | United States | 80045 |
21 | Danbury Hospital | Danbury | Connecticut | United States | 06810 |
22 | Eastern Connecticut Hematology and Oncology Associates; (ECHO) | Norwich | Connecticut | United States | 06360 |
23 | Sylvester Comprehensive Cent. | Miami | Florida | United States | 33136 |
24 | Miami Cancer Institute of Baptist Health, Inc. | Miami | Florida | United States | 33176 |
25 | Women's Cancer Associates | Saint Petersburg | Florida | United States | 33701 |
26 | Sarasota Memorial Health Care System; Cancer Research Program | Sarasota | Florida | United States | 34239 |
27 | Northside Hospital | Atlanta | Georgia | United States | 30342 |
28 | Northeast Georgia Medical Center; Oncology Research Dept-5C | Gainesville | Georgia | United States | 30501 |
29 | Women's Cancer Center | Honolulu | Hawaii | United States | 96826 |
30 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
31 | Univ of Chicago | Chicago | Illinois | United States | 60637 |
32 | Sudarshan K. Sharma, MD, Ltd. | Hinsdale | Illinois | United States | 60521 |
33 | Parkview Research Center | Fort Wayne | Indiana | United States | 46845 |
34 | St.Vincent Health System; Gynecologic Oncology | Indianapolis | Indiana | United States | 46260 |
35 | University of Iowa Hospital & Clinic; Division of Hematology/Oncology | Iowa City | Iowa | United States | 52242 |
36 | University of Kentucky; Gynecologic Oncology | Lexington | Kansas | United States | 40536 |
37 | St. Elizabeth Edgewood; Cancer Care Center" for Account St. Elizabeth Edgewood | Edgewood | Kentucky | United States | 41017 |
38 | Woman's Hospital | Baton Rouge | Louisiana | United States | 70817 |
39 | Maine Medical Partners Women's Health; Gyn-Oncology | Scarborough | Maine | United States | 04074 |
40 | Greater Baltimore Medical Center | Baltimore | Maryland | United States | 21204 |
41 | Sinai Hospital of Baltimore | Baltimore | Maryland | United States | 21215 |
42 | Weinberg CA Inst Franklin Sq | Baltimore | Maryland | United States | 21237 |
43 | Frederick Health Hospital | Frederick | Maryland | United States | 21701 |
44 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
45 | Baystate Medical Center | Springfield | Massachusetts | United States | 01199 |
46 | St. Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
47 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
48 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
49 | Sanford Health Bemidji | Bemidji | Minnesota | United States | 56601 |
50 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
51 | Metro-Minnesota Community Oncology Research Consortium | Saint Louis Park | Minnesota | United States | 55416 |
52 | Minnesota Oncology Hematology Woodbury | Woodbury | Minnesota | United States | 55125 |
53 | St. Dominic-Jackson Memorial Hospital | Jackson | Mississippi | United States | 39216 |
54 | Washington University School of Medicine; Dept of Medicine/Div of Medical Oncology | Saint Louis | Missouri | United States | 63108 |
55 | Billings Clinic; Cancer Center | Billings | Montana | United States | 59101 |
56 | Community Cancer Care | Missoula | Montana | United States | 59804 |
57 | Nebraska Methodist Hospital | Omaha | Nebraska | United States | 68114 |
58 | University of Nebraska Medical Center | Omaha | Nebraska | United States | 68198-0600 |
59 | Women's Cancer Center | Las Vegas | Nevada | United States | 89169 |
60 | Center of Hope | Reno | Nevada | United States | 89511 |
61 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
62 | MSK @Basking Ridge | Basking Ridge | New Jersey | United States | 07920 |
63 | Cooper Health System; MD Anderson Cancer Center | Camden | New Jersey | United States | 08103 |
64 | John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | United States | 07601 |
65 | Memorial Sloan Kettering Cancer Center; MSK Monmouth | Middletown | New Jersey | United States | 07748 |
66 | Jersey Shore Med Ctr; OB/GYN | Neptune | New Jersey | United States | 07753 |
67 | Holy Name Hospital | Teaneck | New Jersey | United States | 07666 |
68 | Southwest Gynecologic Oncology Associates, Inc. | Albuquerque | New Mexico | United States | 87106 |
69 | University of New Mexico Cancer Center | Albuquerque | New Mexico | United States | 87131 |
70 | Womens Cancer Care Association | Albany | New York | United States | 12208 |
71 | New York Presbyterian Queens | Flushing | New York | United States | 11355 |
72 | Northwell Health; Monter Cancer Center | Lake Success | New York | United States | 11042 |
73 | New York Univ Medical Center; Obstetrics & Gynecolog | New York | New York | United States | 10016 |
74 | Mount Sinai Downtown Chelsea Centre | New York | New York | United States | 10029-6574 |
75 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 10029 |
76 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
77 | Memorial Sloan-Kettering CC | Uniondale | New York | United States | 11553 |
78 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
79 | Novant Health Presbyterain Medical Center | Charlotte | North Carolina | United States | 28204 |
80 | Duke Medical Center | Durham | North Carolina | United States | 27710 |
81 | Forsythe Memorial Hospital Inc., dba Novant Health Oncology Specialists | Winston-Salem | North Carolina | United States | 27103 |
82 | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | United States | 27157 |
83 | Sanford Health Bismarck | Bismarck | North Dakota | United States | 58506 |
84 | Sanford Roger Maris Cancer Center | Fargo | North Dakota | United States | 58102 |
85 | University of Cincinnati | Cincinnati | Ohio | United States | 45203-0542 |
86 | Cleveland Clinic | Cleveland | Ohio | United States | 44106 |
87 | Univ Hospitals of Cleveland | Cleveland | Ohio | United States | 44106 |
88 | Fairview Hospital; Cleveland Clinic Cancer Center | Cleveland | Ohio | United States | 44111 |
89 | Columbus NCORP | Columbus | Ohio | United States | 43125 |
90 | Ohio State University, Arthur James Cancer Hospital | Columbus | Ohio | United States | 43210 |
91 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
92 | University of Oklahoma; Stephenson Oklahoma Canc Ctr | Oklahoma City | Oklahoma | United States | 73104 |
93 | Oklahoma Cancer Specialists and Research Institute | Tulsa | Oklahoma | United States | 74146 |
94 | Oncology Associates of Oregon, P.C.; Willamette Valley Cancer Institute | Springfield | Oregon | United States | 97477 |
95 | Northwest Cancer Specialists, P.C. | Tigard | Oregon | United States | 97223 |
96 | University of Pennsylvania Health System; Cancer Center | Philadelphia | Pennsylvania | United States | 19104 |
97 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
98 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
99 | Magee-Woman's Hospital | Pittsburgh | Pennsylvania | United States | 15213 |
100 | Western Pennsylvania Hospital | Pittsburgh | Pennsylvania | United States | 15224 |
101 | Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins | Willow Grove | Pennsylvania | United States | 19090 |
102 | WellSpan Gynecologic Oncology | York | Pennsylvania | United States | 17403 |
103 | Women & Infants Hospital | Providence | Rhode Island | United States | 02905 |
104 | Bon Secours - St. Francis Hospital | Greenville | South Carolina | United States | 29607 |
105 | Monument Health Rapid City Hospital, Inc. | Rapid City | South Dakota | United States | 57701 |
106 | Sanford Health System | Sioux Falls | South Dakota | United States | 57105 |
107 | Dell Seton Medical Center at UT-Seton Infusion Center; Research Department | Austin | Texas | United States | 78701 |
108 | Texas Oncology Cancer Center | Austin | Texas | United States | 78731 |
109 | Texas Oncology | Bedford | Texas | United States | 76022 |
110 | UT Southwestern Medical Center at Dallas; Department of Pathology | Dallas | Texas | United States | 75390-9016 |
111 | Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas | United States | 76104 |
112 | The University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030-4009 |
113 | Houston Methodist Hospital | Houston | Texas | United States | 77030 |
114 | Rocky Mountain Cancer Centers, LLP | Irving | Texas | United States | 75063 |
115 | Texas Oncology San Antonio Medical Center | San Antonio | Texas | United States | 78240 |
116 | Texas Oncology, P.A. | The Woodlands | Texas | United States | 77060 |
117 | Texas Oncology, P.A. - Tyler; Tyler Cancer Center | Tyler | Texas | United States | 75702 |
118 | Dixie Medical Center | Saint George | Utah | United States | 84790 |
119 | Huntsman Cancer Institute; Oncology | Salt Lake City | Utah | United States | 84112 |
120 | University of Virginia | Charlottesville | Virginia | United States | 22906 |
121 | Virginia Cancer Specialists, PC | Fairfax | Virginia | United States | 22031 |
122 | Virginia Oncology Associates | Norfolk | Virginia | United States | 23502 |
123 | Henrico Doctors' Hospital - Forest | Richmond | Virginia | United States | 23229 |
124 | Shenandoah Oncology Associates | Winchester | Virginia | United States | 22601 |
125 | University of Washington Seattle Cancer Care Alliance | Seattle | Washington | United States | 98195 |
126 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
127 | DN Greenwald Center; DN Greenwald Center | Mukwonago | Wisconsin | United States | 53149 |
128 | Aspirus Regional Cancer Center | Wausau | Wisconsin | United States | 54401 |
129 | The Royal North Shore Hospital; Northern Sydney Cancer Centre | St Leonards | New South Wales | Australia | 2065 |
130 | Cabrini Hospital; Cabrini Foundation | Malvern | Victoria | Australia | 3144 |
131 | Peter MacCallum Cancer Center | North Melbourne | Victoria | Australia | 3051 |
132 | Krankenhaus Der Barmherzigen Brüder Graz; Gynäkologie | Graz | Austria | 8020 | |
133 | Tiroler Landeskrankenanstalten Ges.M.B.H.; Abt. Für Gynäkologie | Innsbruck | Austria | 6020 | |
134 | Landeskrankenhaus Salzburg; Gynäkologie Und Onkologie | Salzburg | Austria | 5020 | |
135 | Medizinische Universität Wien; Univ.Klinik für Frauenheilkunde - Klinik für Gynäkologie | Wien | Austria | 1090 | |
136 | AZ Maria Middelares | Gent | Belgium | 9000 | |
137 | UZ Gent | Gent | Belgium | 9000 | |
138 | UZ Leuven Gasthuisberg | Leuven | Belgium | 3000 | |
139 | Sint Augustinus Wilrijk | Wilrijk | Belgium | 2610 | |
140 | Instituto Nacional de Cancer - INCa; Oncologia | Rio de Janeiro | RJ | Brazil | 20560-120 |
141 | Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda | Sao Paulo | SP | Brazil | 01317-001 |
142 | Peking Union Medical College Hospital | Beijing City | China | 100032 | |
143 | Beijing Cancer Hospital | Beijing | China | 100142 | |
144 | West China Second University Hospital | Chengdu City | China | 610066 | |
145 | Chongqing Cancer Hospital | Chongqing | China | 400030 | |
146 | Sun Yet-sen University Cancer Center | Guangzhou | China | 510060 | |
147 | Women's hospital school of medicine Zhejiang University | Hangzhou | China | 310006 | |
148 | Harbin Medical University Cancer Hospital | Harbin | China | 150081 | |
149 | Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Nanjing City | China | 210029 | |
150 | Zhongda Hospital Affiliated to Southeast University | Nanjing | China | 210009 | |
151 | Guangxi Cancer Hospital of Guangxi Medical University | Nanning | China | 530021 | |
152 | Fudan University Shanghai Cancer Center | Shanghai City | China | 200120 | |
153 | Tianjin Central Hospital of Gynecology Obstetrics. | Tianjin City | China | 300052 | |
154 | Zhejiang Cancer Hospital | Zhejiang | China | 310022 | |
155 | Henan Cancer Hospital | Zhengzhou | China | 450008 | |
156 | Fakultni nemocnice Olomouc; Onkologicka klinika | Olomouc | Czechia | 779 00 | |
157 | University Hospital Ostrava; Fakultní nemocnice | Ostrava-Poruba | Czechia | 70852 | |
158 | Gynekologicko-porodnicka klinika | Prague | Czechia | 120 00 | |
159 | Onkologicka klinika UK 2.LF a FN v Motole | Praha 5 | Czechia | 15006 | |
160 | Rigshospitalet; Onkologisk Klinik | København Ø | Denmark | 2100 | |
161 | Kuopio University Hospital | Kuopio | Finland | 70211 | |
162 | Tampereen yliopistollinen sairaala | Tampere | Finland | 33520 | |
163 | Turku Uni Central Hospital; Gynaecology Dept | Turku | Finland | 20521 | |
164 | Clinique Sainte Catherine; Hopital De Semaine | Avignon | France | 84918 | |
165 | Ctr Jean Bernard Clin V. Hugo; Service d'Oncologie Méd | Le Mans | France | 72000 | |
166 | Centre Léon Bérard; Centre régional; le cancer Rhône-Alpes | Lyon | France | 69373 | |
167 | l'Hôpital privé du Confluent SAS | Nantes | France | 44202 | |
168 | Hopital Des Diaconesses; Oncologie | Paris | France | 75571 | |
169 | Centre Hospitalier Lyon Sud | Pierre Benite | France | 69495 | |
170 | Centre Rene Huguenin; CONSULT SPECIALISEES | St Cloud | France | 92210 | |
171 | Institut Gustave Roussy | Villejuif | France | 94805 | |
172 | Campus Virchow-Klinikum Charité; Centrum 17; Klinik für Gynäkologie | Berlin | Germany | 13353 | |
173 | Universitätsklinikum Dresden; Klinik für Frauenheilkunde und Geburtshilfe | Dresden | Germany | 01307 | |
174 | Universitätsklinikum Essen; Zentrum Für Frauenheilkunde | Essen | Germany | 45122 | |
175 | Kliniken Essen Mitte Evang. Huyssens Stiftung/Knappschaft GmbH | Essen | Germany | 45136 | |
176 | Universitätsklinikum Freiburg; Frauenklinik | Freiburg | Germany | 79106 | |
177 | Universitätsklinikum Greifswald; Klinik für Frauenheilkunde und Brustzentrum | Greifswald | Germany | 17475 | |
178 | Universitätsklinikum Hamburg-Eppendorf (UKE); Klinik und Poliklinik für Gynäkologie | Hamburg | Germany | 20246 | |
179 | Medizinische Hochschule Hannover, Klinik für Frauenheilkunde und Geburtshilfe | Hannover | Germany | 30625 | |
180 | Universitätsklinikum Heidelberg; Nationales Centrum für Tumorerkrankungen (NCT) | Heidelberg | Germany | 69120 | |
181 | Klinikum Konstanz, Frauenklinik | Konstanz | Germany | 78464 | |
182 | Universitätsklinikum Schleswig-Holstein / Campus Lübeck; Klinik für Frauenheilkunde und Geburtshilfe | Lübeck | Germany | 23538 | |
183 | Universitätsmedizin Mainz; Klinik u. Poliklinik f. Geburtshilfe u. Frauenheilkunde | Mainz | Germany | 55131 | |
184 | Klinikum der Universität München; Campus Großhadern; Klinik und Poliklinik für Frauenheilkunde | Muenchen | Germany | 81377 | |
185 | Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde | München | Germany | 81675 | |
186 | Klinikum Südstadt | Rostock | Germany | 18059 | |
187 | Universitätsklinikum Ulm Am Michelsberg; Frauenklinik | Ulm | Germany | 89075 | |
188 | HELIOS Dr. Horst Schmidt Kliniken Wiesbaden; Klinik für Gynäkologie und gynäkologische Onkologie | Wiesbaden | Germany | 65199 | |
189 | Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine | Athens | Greece | 115 28 | |
190 | Uni Hospital of Ioannina; Oncology Dept. | Ioannina | Greece | 455 00 | |
191 | Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept. | Kifisia | Greece | 145 64 | |
192 | University Hospital of Patras Medical Oncology | Patras | Greece | 265 04 | |
193 | EUROMEDICA General Clinic of Thessaloniki; Medical Oncology Dept - Oncomedicare | Thessaloniki | Greece | 546 45 | |
194 | Hillel Yaffe MC; Gynaecology | Hadera | Israel | 3810101 | |
195 | Shaare Zedek Medical Center; Oncology Dept | Jerusalem | Israel | 9103102 | |
196 | Meir Medical Center; Obstetrics and Gynecology | Kfar Saba | Israel | 4428164 | |
197 | Chaim Sheba Medical Center; Obstetrics and Gynecology | Ramat Gan | Israel | 5262100 | |
198 | Kaplan Medical Center; Oncology Inst. | Rehovot | Israel | 7610001 | |
199 | Azienda Ospedaliera Universitaria Federico II | Napoli | Campania | Italy | 80131 |
200 | ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico | Napoli | Campania | Italy | 80131 |
201 | Policlinico S.Orsola-Malpighi; Istituto Oncologia R. Addarii | Bologna | Emilia-Romagna | Italy | 40138 |
202 | Ospedale Degli Infermi - Faenza; Oncologia Medica | Faenza | Emilia-Romagna | Italy | 48018 |
203 | IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica | Meldola | Emilia-Romagna | Italy | 47014 |
204 | Arcispedale Santa Maria Nuova; Oncologia | Reggio Emilia | Emilia-Romagna | Italy | 42100 |
205 | Policlinico A. Gemelli e C.I.C.; Area Salute della Donna | Roma | Lazio | Italy | 00168 |
206 | A.O.Spedali Civili; Ostetricia e Ginecologia | Brescia | Lombardia | Italy | 25123 |
207 | IRCCS S. Raffaele; Ginecologia Oncologica | Milano | Lombardia | Italy | 20132 |
208 | Istituto Nazionale dei Tumori; Divisione Oncologia Chirurgica e Ginecologica | Milano | Lombardia | Italy | 20133 |
209 | Irccs Istituto Europeo Di Oncologia (IEO); Oncologia Medica | Milano | Lombardia | Italy | 20141 |
210 | Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia | Milano | Lombardia | Italy | 20162 |
211 | A.O. San Gerardo; Ginecologia | Monza | Lombardia | Italy | 20052 |
212 | A. O. Città della Salute e della Scienza; Unità di Oncologia Ginecologica | Torino | Piemonte | Italy | 10126 |
213 | Ospedale Mauriziano Umberto 1; Ginecologia - Oncologia | Torino | Piemonte | Italy | 10128 |
214 | Ospedale Antonio Perrino; Oncologia Medica | Brindisi | Puglia | Italy | 72100 |
215 | Ospedale Silvestrini; Oncologia ed Ematologia | Perugia | Umbria | Italy | 06123 |
216 | IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda | Padova | Veneto | Italy | 35128 |
217 | Nagoya University Hospital | Aichi | Japan | 466-8560 | |
218 | National Hospital Organization Shikoku Cancer Center | Ehime | Japan | 791-0280 | |
219 | Ehime University Hospital | Ehime | Japan | 791-0295 | |
220 | NHO Kyushu Cancer Center | Fukuoka | Japan | 811-1395 | |
221 | Kyushu University Hospital | Fukuoka | Japan | 812-8582 | |
222 | Kurume University Hospital | Fukuoka | Japan | 830-0011 | |
223 | Kure Medical Center | Hiroshima | Japan | 737-0023 | |
224 | National Hospital Organization Hokkaido Cancer Center | Hokkaido | Japan | 003-0804 | |
225 | Hyogo Cancer Center | Hyogo | Japan | 673-0021 | |
226 | Iwate Medical University Hospital | Iwate | Japan | 028-3695 | |
227 | Kagoshima University Hospital | Kagoshima | Japan | 890-8520 | |
228 | Yokohama City University Hospital | Kanagawa | Japan | 236-0004 | |
229 | Kyoto University Hospital | Kyoto | Japan | 606-8507 | |
230 | Mie University Hospital | Mie | Japan | 514-8507 | |
231 | Tohoku University Hospital | Miyagi | Japan | 980-8574 | |
232 | Niigata University Medical & Dental Hospital | Niigata | Japan | 951-8520 | |
233 | Osaka International Cancer Institute | Osaka | Japan | 541-8567 | |
234 | Shizuoka Cancer Center | Shizuoka | Japan | 411-8777 | |
235 | The Jikei University Hospital | Tokyo | Japan | 105-8471 | |
236 | The University of Tokyo Hospital | Tokyo | Japan | 113-8655 | |
237 | The Cancer Institute Hospital of JFCR | Tokyo | Japan | 135-8550 | |
238 | Keio University Hospital | Tokyo | Japan | 160-8582 | |
239 | National Cancer Center | Goyang-si | Korea, Republic of | 10408 | |
240 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
241 | Asan Medical Center | Seoul | Korea, Republic of | 05505 | |
242 | Samsung Medical Center | Seoul | Korea, Republic of | 06351 | |
243 | Oslo Universitetssykehus HF; Radiumhospitalet | Oslo | Norway | 0310 | |
244 | St. Olavs Hospital | Trondheim | Norway | 7006 | |
245 | Centrum Onkologii Instytut im. M.Sklodowskiej-Curie; Klinika Ginekologii Onkologicznej | Krakow | Poland | 31-115 | |
246 | Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu; Oddział Ginekologii Onkologicznej | Poznań | Poland | 60-569 | |
247 | Icu Spsk - 2 | Szczecin | Poland | 70-111 | |
248 | Narodowy Instytut Onkologii im. M.Sklodowskiej-Curie;Klinika Ginekologii Onkologicznej | Warszawa | Poland | 02-781 | |
249 | Moscow City Oncology Hospital #62 | Moscovskaya Oblast | Moskovskaja Oblast | Russian Federation | 143423 |
250 | Clinical Oncology Dispensary of Ministry of Health of Tatarstan | Kazan | Russian Federation | 420029 | |
251 | N.N.Burdenko Main Military Clinical Hospital; Oncology Dept | Moscow | Russian Federation | 105229 | |
252 | St. Petersburg Oncology & Gynecology; City Clinical Oncology Dispensary | Saint-Petersburg | Russian Federation | 197022 | |
253 | Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | Spain | 8208 |
254 | Hospital Universitario Son Espases | Palma de Mallorca | Islas Baleares | Spain | 07010 |
255 | Fundacion Hospital de Alcorcon; Servicio de Oncologia | Alcorcon | Madrid | Spain | 28922 |
256 | Hospital Universitari Dexeus - Grupo Quironsalud; Servicio de Oncologia Medica | Barcelona | Spain | 08028 | |
257 | Hospital General Universitario Gregorio Marañon; Servicio de Oncologia | Madrid | Spain | 28007 | |
258 | Centro Integral Oncologico Clara Campal; Servicio de Oncología | Madrid | Spain | 28050 | |
259 | Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Malaga | Spain | 29010 | |
260 | Hospital Universitario la Fe; Servicio de Oncologia | Valencia | Spain | 46026 | |
261 | Hospital Universitario Miguel Servet; Servicio Oncologia | Zaragoza | Spain | 50009 | |
262 | Uni Hospital Linkoeping; Dept. of Oncology | Linköping | Sweden | 58185 | |
263 | Karolinska Hospital; Oncology - Radiumhemmet | Stockholm | Sweden | 171 76 | |
264 | Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology | Adana | Turkey | 01230 | |
265 | Ankara University Medical Faculty; Medikal Onkoloji | Ankara | Turkey | 06100 | |
266 | Baskent Universitesi Ankara Hastanesi; Tıbbi Onkoloji Bölümü | Ankara | Turkey | 06490 | |
267 | Koc University Medical Faculty; Department of Gynecology & Obstetrics | Istanbul | Turkey | 34010 | |
268 | Istanbul Uni Istanbul Medical Faculty | Istanbul | Turkey | 34093 | |
269 | Istanbul University Cerrahpasa Medical Faculty; Obstetrics and Gynecology | Istanbul | Turkey | 34098 |
Sponsors and Collaborators
- Hoffmann-La Roche
- GOG Foundation
- European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- YO39523
- 2016-003472-52