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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
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
Secondary ID [1] 0 0
2016-003472-52
Secondary ID [2] 0 0
YO39523
Universal Trial Number (UTN)
Trial acronym
IMagyn050
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ovarian Cancer 0 0
Fallopian Tube Cancer 0 0
Peritoneal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Stomach

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
From randomization until disease progression or death from any cause (up to approximately 55 months)
Primary outcome [2] 0 0
PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
Timepoint [2] 0 0
From randomization until disease progression or death from any cause (up to approximately 55 months)
Primary outcome [3] 0 0
Overall Survival - ITT Population
Timepoint [3] 0 0
From randomization up to death from any cause (up to approximately 59 months)
Primary outcome [4] 0 0
Overall Survival - PD-L1-Positive Subpopulation
Timepoint [4] 0 0
From randomization up to death from any cause (up to approximately 59 months)
Secondary outcome [1] 0 0
Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
Timepoint [1] 0 0
From randomization until disease progression or death from any cause (up to approximately 55 months)
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
From randomization until disease progression or death from any cause (up to approximately 55 months)
Secondary outcome [3] 0 0
Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
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
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
Timepoint [6] 0 0
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.
Secondary outcome [7] 0 0
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Timepoint [7] 0 0
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.
Secondary outcome [8] 0 0
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
Timepoint [9] 0 0
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.
Secondary outcome [10] 0 0
Percentage of Participants With at Least One Adverse Event
Timepoint [10] 0 0
From randomization up to approximately 59 months
Secondary outcome [11] 0 0
Maximum Serum Concentration (Cmax) of Atezolizumab
Timepoint [11] 0 0
Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
Secondary outcome [12] 0 0
Minimum Serum Concentration (Cmin) of Atezolizumab
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab
Timepoint [13] 0 0
Baseline to approximately 55 months

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/08/2022
Sample size
Target
Accrual to date
Final
1301
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
The Royal North Shore Hospital; Northern Sydney Cancer Centre - St Leonards
Recruitment hospital [2] 0 0
Cabrini Hospital; Cabrini Foundation - Malvern
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Center - North Melbourne
Recruitment postcode(s) [1] 0 0
2065 - St Leonards
Recruitment postcode(s) [2] 0 0
3144 - Malvern
Recruitment postcode(s) [3] 0 0
3051 - North Melbourne
Recruitment outside Australia
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United States of America
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Arizona
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California
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Ulm
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Israel
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Mie
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Niigata
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Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Goyang-si
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Korea, Republic of
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Seoul
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Norway
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Oslo
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Norway
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Trondheim
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Poland
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Krakow
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Poland
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Pozna?
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Poland
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Szczecin
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Poland
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Warszawa
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Russian Federation
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Moskovskaja Oblast
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Spain
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Barcelona
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Spain
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Islas Baleares
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Linköping
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Sweden
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Stockholm
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
GOG Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT03038100