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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03038100
Collaborator
GOG Foundation (Other), European Network of Gynaecological Oncological Trial Groups (ENGOT) (Other)
1,301
269
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72.7
4.8
0.1

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1301 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Actual Study Start Date :
Mar 8, 2017
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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

  1. 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)]

  2. 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)]

  3. Overall Survival - ITT Population [From randomization up to death from any cause (up to approximately 60 months)]

  4. Overall Survival - PD-L1-Positive Subpopulation [From randomization up to death from any cause (up to approximately 60 months)]

Secondary Outcome Measures

  1. 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)]

  2. 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)]

  3. 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).

  4. 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).

  5. 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.

  6. 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)]

  7. 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)

  8. 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)

  9. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Participants receiving a histologic diagnosis of epithelial ovarian cancer (EOC), peritoneal primary carcinoma, or fallopian tube cancer

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

  • Life expectancy greater than (>) 12 weeks

  • For participants who receive therapeutic anticoagulation: stable anticoagulant regimen

  • 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:
  • Received a current diagnosis of borderline epithelial ovarian tumor (formerly tumors of low malignant potential)

  • 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)

  • Have non-epithelial ovarian tumors (e.g., germ cell tumors, sex cord stromal tumors)

  • Received prior radiotherapy to any portion of the abdominal cavity or pelvis

  • Received prior chemotherapy for any abdominal or pelvic tumor that include neoadjuvant chemotherapy (NACT) for ovarian, primary peritoneal or fallopian tube cancer

  • 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

  • Have synchronous primary endometrial cancer

  • 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

  • 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

  • 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

  • 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.

  • Have prior allogeneic bone marrow transplantation or solid organ transplant

  • 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

  • Have any approved or investigational anti-cancer therapy, including chemotherapy or hormonal therapy, with exceptions: Hormone-replacement therapy or oral contraceptives

  • Are administered treatment with any other investigational agent or participation in another clinical study with anti-cancer therapeutic intent

  • Have core biopsy or other minor surgical procedures within 7 days prior to the first dose of bevacizumab

  • Have known sensitivity to any component of bevacizumab

  • Have known sensitivity to any component of paclitaxel

  • Current treatment with anti-viral therapy for hepatitis B virus (HBV)

  • History of leptomeningeal disease

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT03038100
Other Study ID Numbers:
  • YO39523
  • 2016-003472-52
First Posted:
Jan 31, 2017
Last Update Posted:
Aug 15, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2022