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← CISplatin: metastatic Ovarian Tumors

NCT03038100 · STUDY IN CONTEXT

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 Tu

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.

→

primary · POSTED

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.

PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.

→

primary · POSTED

Overall Survival (OS) is defined as the time from randomization to death from any cause.

Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.

→

primary · POSTED

Overall Survival (OS) is defined as the time from randomization to death from any cause.

PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.

→

secondary · POSTED

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.

Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline.

→

secondary · POSTED

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.

Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the PD-L1-Positive subpopulation with measurable disease at baseline.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

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

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT03038100
qol key
qol-0008
source section id
NCT03038100-om-0008
source outcome index
8
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
measure definition
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).
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.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Neoadjuvant Group. PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT03038100
qol key
qol-0009
source section id
NCT03038100-om-0009
source outcome index
9
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
measure definition
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).
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.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT03038100
qol key
qol-0010
source section id
NCT03038100-om-0010
source outcome index
10
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
measure definition
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.
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.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT03038100
qol key
qol-0011
source section id
NCT03038100-om-0011
source outcome index
11
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
measure definition
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.
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.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT03038100
qol key
qol-0012
source section id
NCT03038100-om-0012
source outcome index
12
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
measure definition
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.
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.
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-ovarian-neoplasm-cisplatin-6f0c5203
nct id
NCT03038100
trial label
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 Tu
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
5
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0000
    source section id
    NCT03038100-om-0000
    source outcome index
    0
    endpoint
    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
    endpoint definition
    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.
    time origin
    From randomization until disease progression or death from any cause (up to approximately 55 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0001
    source section id
    NCT03038100-om-0001
    source outcome index
    1
    endpoint
    PFS Assessed by Investigator as Per RECIST v1.1 - Programmed Death-Ligand 1 (PD-L1)-Positive Subpopulation
    endpoint definition
    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.
    time origin
    From randomization until disease progression or death from any cause (up to approximately 55 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0002
    source section id
    NCT03038100-om-0002
    source outcome index
    2
    endpoint
    Overall Survival - ITT Population
    endpoint definition
    Overall Survival (OS) is defined as the time from randomization to death from any cause.
    time origin
    From randomization up to death from any cause (up to approximately 59 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Intent-to-Treat (ITT) population is defined as all randomized patients, whether or not the assigned study treatment was received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0003
    source section id
    NCT03038100-om-0003
    source outcome index
    3
    endpoint
    Overall Survival - PD-L1-Positive Subpopulation
    endpoint definition
    Overall Survival (OS) is defined as the time from randomization to death from any cause.
    time origin
    From randomization up to death from any cause (up to approximately 59 months)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    PD-L1-positive subpopulation is defined as patients in the ITT population whose PD-L1 status was IC1/2/3 at the time of randomization.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0004
    source section id
    NCT03038100-om-0004
    source outcome index
    4
    endpoint
    Percentage of Participants With Objective Response (OR) Assessed by Investigator as Per RECIST v1.1 - Primary Tumor-Reductive Surgery Group in ITT Population
    endpoint definition
    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.
    time origin
    From randomization until disease progression or death from any cause (up to approximately 55 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the ITT population with measurable disease at baseline.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0005
    source section id
    NCT03038100-om-0005
    source outcome index
    5
    endpoint
    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
    endpoint definition
    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.
    time origin
    From randomization until disease progression or death from any cause (up to approximately 55 months)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Objective Response Rate (ORR) - evaluable population is defined as primary surgery patients in the PD-L1-Positive subpopulation with measurable disease at baseline.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
    analyzed count
    650
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    analyzed count
    651
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
    analyzed count
    393
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    analyzed count
    391
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
    analyzed count
    650
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    analyzed count
    651
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
    analyzed count
    393
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    analyzed count
    391
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
    analyzed count
    650
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    analyzed count
    651
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and placebo for additional 16 cycles.
    analyzed count
    393
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    regimen
    Participants in the primary tumor-reductive surgery group received 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 received 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 started maintenance therapy of bevacizumab and atezolizumab for additional 16 cycles.
    analyzed count
    391
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03038100-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    harm key
    EG000
    source section id
    NCT03038100-ae
    event group key
    EG000
    event group label
    Atezolizumab With Paclitaxel, Carboplatin and Bevacizumab
    serious affected
    304
    serious at risk
    642
    other affected
    637
    other at risk
    642
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
    event definition
    All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    harm key
    EG001
    source section id
    NCT03038100-ae
    event group key
    EG001
    event group label
    Placebo With Paclitaxel, Carboplatin and Bevacizumab
    serious affected
    215
    serious at risk
    644
    other affected
    637
    other at risk
    644
    frequency threshold
    5
    collection period
    From the first study drug to the data cutoff date: 12 August 2022 (up to 65 months)
    event definition
    All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any study drug.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    qol key
    qol-0008
    source section id
    NCT03038100-om-0008
    source outcome index
    8
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Abdominal Pain and Bloating - Neoadjuvant Group
    measure definition
    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).
    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.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Neoadjuvant Group. PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment. The ITT population is defined as all randomized patients, whether or not the assigned study treatment was received.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    qol key
    qol-0009
    source section id
    NCT03038100-om-0009
    source outcome index
    9
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and Health Related Quality of Life (HRQoL) - Neoadjuvant Group
    measure definition
    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).
    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.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    qol key
    qol-0010
    source section id
    NCT03038100-om-0010
    source outcome index
    10
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Percentage of Participants Who Achieve a Clinically-Meaningful Improvement in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
    measure definition
    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.
    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.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    qol key
    qol-0011
    source section id
    NCT03038100-om-0011
    source outcome index
    11
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Percentage of Participants Who Remain Stable in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
    measure definition
    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.
    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.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-ovarian-neoplasm-cisplatin-6f0c5203
    nct id
    NCT03038100
    qol key
    qol-0012
    source section id
    NCT03038100-om-0012
    source outcome index
    12
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Percentage of Participants With Deterioration in Patient-Reported Function and HRQoL - Primary Tumor-Reductive Surgery Group
    measure definition
    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.
    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.
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    PRO-evaluable population is defined as patients in the ITT population with a baseline and \>=1 post-baseline PRO assessment.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice