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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03038100
Registration number
NCT03038100
Ethics application status
Date submitted
30/01/2017
Date registered
31/01/2017
Date last updated
17/02/2023
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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2016-003472-52
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Secondary ID [2]
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YO39523
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Universal Trial Number (UTN)
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Trial acronym
IMagyn050
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer
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Fallopian Tube Cancer
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Peritoneal Neoplasms
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Condition category
Condition code
Cancer
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Womb (Uterine or endometrial cancer)
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Cancer
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Carboplatin
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Atezolizumab Placebo
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.
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.
Treatment: Drugs: Paclitaxel
Paclitaxel 175 milligrams per square meter (mg/m\^2) IV infusion on Day 1 of each 21-day cycle
Treatment: Drugs: 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
Treatment: Drugs: Atezolizumab
Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
Treatment: Drugs: Bevacizumab
Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
Treatment: Drugs: Atezolizumab Placebo
Placebo matching to atezolizumab on Day 1 of each 21-day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
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Timepoint [1]
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From randomization until disease progression or death from any cause (up to approximately 55 months)
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Primary outcome [2]
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PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
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Assessment method [2]
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Investigator-assessed PFS is defined as the time from randomization to the occurrence of disease progression, as determined by the investigator from tumor assessments per RECIST v1.1, or death from any cause during the study, whichever occurs first.
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Timepoint [2]
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From randomization until disease progression or death from any cause (up to approximately 55 months)
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Primary outcome [3]
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Overall Survival - ITT Population
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Assessment method [3]
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Overall Survival (OS) is defined as the time from randomization to death from any cause.
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Timepoint [3]
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From randomization up to death from any cause (up to approximately 59 months)
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Primary outcome [4]
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Overall Survival - PD-L1-Positive Subpopulation
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Assessment method [4]
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Overall Survival (OS) is defined as the time from randomization to death from any cause.
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Timepoint [4]
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From randomization up to death from any cause (up to approximately 59 months)
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Secondary outcome [1]
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Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
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Assessment method [1]
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OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
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Timepoint [1]
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From randomization until disease progression or death from any cause (up to approximately 55 months)
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Secondary outcome [2]
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Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in PD-L1-Positive Population
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Assessment method [2]
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OR is defined as either a CR or PR as determined by the investigator with the use of RECIST v1.1 for patients with measurable residual disease after primary surgery.
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Timepoint [2]
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From randomization until disease progression or death from any cause (up to approximately 55 months)
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Secondary outcome [3]
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Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
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Assessment method [3]
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DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.
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Timepoint [3]
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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)
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Secondary outcome [4]
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Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in PD-L1-Positive Population
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Assessment method [4]
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DOR is defined as the time interval from first occurrence of a CR or PR to the time of disease progression, as determined by the investigator with the use of RECIST v1.1, or death from any cause, whichever comes first for patients with measurable residual disease after primary surgery.
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Timepoint [4]
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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)
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Secondary outcome [5]
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Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
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Assessment method [5]
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Clinically-meaningful improvement defined as a \>=10-point decrease from the baseline score 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).
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Timepoint [5]
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From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
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Secondary outcome [6]
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Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
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Assessment method [6]
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Clinically-meaningful improvement in patient-reported function and HRQoL during the treatment period, defined as a \>=10-point increase from the baseline score on each of the functional (social, emotional, physical, role) and GHS/QoLscales of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaires Core 30 (EORTC QLQ-C30).
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Timepoint [6]
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From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
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Secondary outcome [7]
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Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
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Assessment method [7]
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Percentage of participants with clinical improvement, defined as \>= 10-point increase from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
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Timepoint [7]
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From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
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Secondary outcome [8]
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Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
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Assessment method [8]
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Percentage of participants who remain stable defined as changes within 10 points from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
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Timepoint [8]
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From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 55 months). Cycle length=21 days.
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Secondary outcome [9]
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Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
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Assessment method [9]
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Percentage of participants with deterioration in patient-reported function and HRQoL, defined as \>= 10 points decrease from the baseline score on each of the functional (physical, role, emotional, and social) and GHS/QoL scales of the EORTC QLQ-C30.
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Timepoint [9]
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From randomization to the end of treatment/discontinuation (up to approximately 66 weeks), and during follow-up period (up to approximately 60 months). Cycle length=21 days.
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Secondary outcome [10]
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Percentage of Participants With at Least One Adverse Event
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Assessment method [10]
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Percentage of participants with at least one adverse event.
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Timepoint [10]
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From randomization up to approximately 59 months
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Secondary outcome [11]
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Maximum Serum Concentration (Cmax) of Atezolizumab
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Assessment method [11]
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Timepoint [11]
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Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
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Secondary outcome [12]
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Minimum Serum Concentration (Cmin) of Atezolizumab
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Assessment method [12]
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Timepoint [12]
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Cycle 2 Day 1 predose, Cycle 3 Day 1 Predose, Cycle 4 Day 1 predose, Cycle 8 Day 1 predose, Cycle 16 Day 1 predose
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Secondary outcome [13]
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Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
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Assessment method [13]
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Timepoint [13]
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Baseline to approximately 55 months
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Eligibility
Key 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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/03/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
12/08/2022
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Sample size
Target
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Accrual to date
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Final
1301
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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The Royal North Shore Hospital; Northern Sydney Cancer Centre - St Leonards
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Recruitment hospital [2]
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Cabrini Hospital; Cabrini Foundation - Malvern
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Recruitment hospital [3]
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Peter MacCallum Cancer Center - North Melbourne
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Recruitment postcode(s) [2]
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3144 - Malvern
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Recruitment postcode(s) [3]
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3051 - North Melbourne
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Recruitment outside Australia
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Arizona
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California
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Graz
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China
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Beijing
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China
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Harbin
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China
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China
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Nanjing
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China
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Nanning
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China
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China
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Zhejiang
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China
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Zhengzhou
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Czechia
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Olomouc
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Czechia
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Ostrava-Poruba
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Prague
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Kuopio
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France
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Nantes
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France
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France
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Germany
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Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Other
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GOG Foundation
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Other
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European Network of Gynaecological Oncological Trial Groups (ENGOT)
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT03038100
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Trial related presentations / publications
Moore KN, Bookman M, Sehouli J, Miller A, Anderson C, Scambia G, Myers T, Taskiran C, Robison K, Maenpaa J, Willmott L, Colombo N, Thomes-Pepin J, Liontos M, Gold MA, Garcia Y, Sharma SK, Darus CJ, Aghajanian C, Okamoto A, Wu X, Safin R, Wu F, Molinero L, Maiya V, Khor VK, Lin YG, Pignata S. Atezolizumab, Bevacizumab, and Chemotherapy for Newly Diagnosed Stage III or IV Ovarian Cancer: Placebo-Controlled Randomized Phase III Trial (IMagyn050/GOG 3015/ENGOT-OV39). J Clin Oncol. 2021 Jun 10;39(17):1842-1855. doi: 10.1200/JCO.21.00306. Epub 2021 Apr 23. Erratum In: J Clin Oncol. 2021 Jul 20;39(21):2420. doi: 10.1200/JCO.21.01441. Moore KN, Pignata S. Trials in progress: IMagyn050/GOG 3015/ENGOT-OV39. 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. Int J Gynecol Cancer. 2019 Jan 10:ijgc-2018-000071. doi: 10.1136/ijgc-2018-000071. Online ahead of print.
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Public notes
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Contacts
Principal investigator
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Hoffmann-La Roche
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/00/NCT03038100/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/00/NCT03038100/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03038100
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