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NCT03038100 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2023-02-17

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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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outcome · POSTED

PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation

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outcome · POSTED

Overall Survival - ITT Population

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outcome · POSTED

Overall Survival - PD-L1-Positive Subpopulation

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outcome · POSTED

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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outcome · POSTED

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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outcome · POSTED

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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outcome · POSTED

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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outcome · POSTED

Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group

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outcome · POSTED

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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outcome · POSTED

Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group

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outcome · POSTED

Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group

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outcome · POSTED

Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group

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outcome · POSTED

Percentage of Participants With at Least One Adverse Event

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outcome · POSTED

Maximum Serum Concentration (Cmax) of Atezolizumab

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outcome · POSTED

Minimum Serum Concentration (Cmin) of Atezolizumab

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outcome · POSTED

Percentage of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Carboplatin
    3. Drug: Atezolizumab
    4. Drug: Bevacizumab
    label
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Paclitaxel
    2. Drug: Carboplatin
    3. Drug: Bevacizumab
    4. Drug: Atezolizumab Placebo
    label
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    2. Placebo With Paclitaxel, Carboplatin and Bevacizumab
    description
    Paclitaxel 175 milligrams per square meter (mg/m\^2) IV infusion on Day 1 of each 21-day cycle
    name
    Paclitaxel
    type
    DRUG
  2. arm Group Labels
    1. Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    2. Placebo With Paclitaxel, Carboplatin and Bevacizumab
    description
    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
    name
    Carboplatin
    type
    DRUG
  3. arm Group Labels
    1. Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    description
    Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
    name
    Atezolizumab
    type
    DRUG
  4. arm Group Labels
    1. Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    2. Placebo With Paclitaxel, Carboplatin and Bevacizumab
    description
    Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
    name
    Bevacizumab
    type
    DRUG
  5. arm Group Labels
    1. Placebo With Paclitaxel, Carboplatin and Bevacizumab
    description
    Placebo matching to atezolizumab on Day 1 of each 21-day cycle
    name
    Atezolizumab Placebo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
TREATMENT
Enrollment
count
1301
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    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
    time Frame
    From randomization until disease progression or death from any cause (up to approximately 55 months)
  2. description
    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.
    measure
    PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
    time Frame
    From randomization until disease progression or death from any cause (up to approximately 55 months)
  3. description
    Overall Survival (OS) is defined as the time from randomization to death from any cause.
    measure
    Overall Survival - ITT Population
    time Frame
    From randomization up to death from any cause (up to approximately 59 months)
  4. description
    Overall Survival (OS) is defined as the time from randomization to death from any cause.
    measure
    Overall Survival - PD-L1-Positive Subpopulation
    time Frame
    From randomization up to death from any cause (up to approximately 59 months)
secondary Outcomes
  1. description
    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.
    measure
    Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
    time Frame
    From randomization until disease progression or death from any cause (up to approximately 55 months)
  2. description
    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.
    measure
    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
    time Frame
    From randomization until disease progression or death from any cause (up to approximately 55 months)
  3. description
    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.
    measure
    Duration of Response Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery (Having Residual Measurable Disease) Group in ITT Population
    time Frame
    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)
  4. description
    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.
    measure
    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
    time Frame
    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)
  5. description
    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).
    measure
    Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
    time Frame
    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.
  6. description
    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).
    measure
    Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
    time Frame
    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.
  7. description
    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.
    measure
    Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
    time Frame
    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.
  8. description
    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.
    measure
    Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
    time Frame
    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.
  9. description
    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.
    measure
    Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
    time Frame
    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.
  10. description
    Percentage of participants with at least one adverse event.
    measure
    Percentage of Participants With at Least One Adverse Event
    time Frame
    From randomization up to approximately 59 months
  11. measure
    Maximum Serum Concentration (Cmax) of Atezolizumab
    time Frame
    Cycle 1 Day 1 post dose and Cycle 3 Day 1 post dose
  12. measure
    Minimum Serum Concentration (Cmin) of Atezolizumab
    time Frame
    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
Full 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.
Source references
references
  1. citation
    Pignata S, Bookman M, Sehouli J, Miller A, Penson RT, Taskiran C, Anderson C, Hietanen S, Myers T, Madry R, Willmott L, Lortholary A, Thomes-Pepin J, Aghajanian C, McCourt C, Stuckey A, Wu X, Nishio S, Copeland LJ, He Y, Molinero L, Patel S, Lin YG, Khor VK, Moore KN. Overall survival and patient-reported outcome results from the placebo-controlled randomized phase III IMagyn050/GOG 3015/ENGOT-OV39 trial of atezolizumab for newly diagnosed stage III/IV ovarian cancer. Gynecol Oncol. 2023 Oct;177:20-31. doi: 10.1016/j.ygyno.2023.06.018. Epub 2023 Aug 23.
    pmid
    37625235
    type
    DERIVED
  2. citation
    Landen CN, Molinero L, Hamidi H, Sehouli J, Miller A, Moore KN, Taskiran C, Bookman M, Lindemann K, Anderson C, Berger R, Myers T, Beiner M, Reid T, Van Nieuwenhuysen E, Green A, Okamoto A, Aghajanian C, Thaker PH, Blank SV, Khor VK, Chang CW, Lin YG, Pignata S. Influence of Genomic Landscape on Cancer Immunotherapy for Newly Diagnosed Ovarian Cancer: Biomarker Analyses from the IMagyn050 Randomized Clinical Trial. Clin Cancer Res. 2023 May 1;29(9):1698-1707. doi: 10.1158/1078-0432.CCR-22-2032.
    pmid
    36595569
    type
    DERIVED
  3. citation
    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.
    pmid
    33891472
    type
    DERIVED
  4. citation
    Moore KN, Pignata S; IMagyn050 Steering Committee. 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 Feb 4;29(2):430-433. doi: 10.1136/ijgc-2018-000071.
    pmid
    30630885
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        udy treatment and experienced grade 3 to 5 serious adverse events than patients in the chemotherapy-alone arm.</li></ul></div></li><li><a href="/clinicaltrials/NCT03038100">IMagyn050</a> (NCT03038100) was a multicenter, placebo-controlled, double-blind, randomized phase III trial of platinum-based chemotherapy and bevacizumab wit
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        d grade 3 to 5 serious adverse events than patients in the chemotherapy-alone arm.</li></ul></div></li><li><a href="/clinicaltrials/NCT03038100">IMagyn050</a> (NCT03038100) was a multicenter, placebo-controlled, double-blind, randomized phase III trial of platinum-based chemotherapy and bevacizumab with or without atezolizumab, a
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      1. context
        Updated: May 14, 2025
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    Preserved source evidence · Not medical advice