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← Fallopian Tube Neoplasm

NCT05116189 · STUDY IN CONTEXT

Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.

→

primary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they are randomized.

→

secondary · POSTED

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.

→

secondary · POSTED

PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in all participants is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.

The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they are randomized.

→

secondary · NOT_POSTED

OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.

Source null

→

secondary · NOT_POSTED

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.

Source null

→

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 · Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

Score direction: Higher is better, according to the source. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-fallopian-tube-neoplasm
nct id
NCT05116189
qol key
qol-0007
source section id
NCT05116189-om-0007
source outcome index
7
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
measure definition
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
time frame
Baseline and up to ~64 months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
1
direction quote
higher score indicates a better
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30

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-fallopian-tube-neoplasm
nct id
NCT05116189
qol key
qol-0008
source section id
NCT05116189-om-0008
source outcome index
8
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30
measure definition
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
time frame
Up to ~64 months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale

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-fallopian-tube-neoplasm
nct id
NCT05116189
qol key
qol-0009
source section id
NCT05116189-om-0009
source outcome index
9
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
measure definition
The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome.
time frame
Baseline and up to ~64 months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
EORTC QLQ · TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale

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-fallopian-tube-neoplasm
nct id
NCT05116189
qol key
qol-0010
source section id
NCT05116189-om-0010
source outcome index
10
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale
measure definition
TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
time frame
Up to ~64 months
analysis role
secondary
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
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-fallopian-tube-neoplasm
nct id
NCT05116189
trial label
Pembrolizumab/Placebo Plus Paclitaxel With or Without Bevacizumab for Platinum-resistant Recurrent Ovarian Cancer (MK-3475-B96/KEYNOTE-B96/ENGOT-ov65).
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
4
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0000
    source section id
    NCT05116189-om-0000
    source outcome index
    0
    endpoint
    Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors (Combined Positive Score [CPS] ≥1)
    endpoint definition
    PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. Per protocol, PFS per RECIST 1.1 as assessed by the Investigator in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
    time origin
    Up to ~38 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0001
    source section id
    NCT05116189-om-0001
    source outcome index
    1
    endpoint
    PFS Per RECIST 1.1 as Assessed by the Investigator in All Participants
    endpoint definition
    PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 based on Investigator assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions was also considered PD. PFS per RECIST 1.1 as assessed by the Investigator will be reported for all participants. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
    time origin
    Up to ~38 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they are randomized.
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0002
    source section id
    NCT05116189-om-0002
    source outcome index
    2
    endpoint
    PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in Participants With PD-L1 CPS ≥1
    endpoint definition
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in participants with PD-L1 CPS ≥1 is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
    time origin
    Up to ~38 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population includes all randomized participants with PD-L1 positive tumors (CPS≥1). Participants were analyzed in the treatment group to which they are randomized.
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0003
    source section id
    NCT05116189-om-0003
    source outcome index
    3
    endpoint
    PFS Per RECIST 1.1 by Blinded Independent Central Review (BICR) in All Participants
    endpoint definition
    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review assessment or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Per protocol, RECIST 1.1 was modified to allow up to 10 target lesions total (up to 5 per organ). The appearance of one or more lesions and the unequivocal progression of non-target lesions is also considered PD. The PFS per RECIST 1.1 as assessed by blinded independent central review (BICR) in all participants is reported here. PFS was calculated using the product-limit (Kaplan-Meier) method for censored data.
    time origin
    Up to ~38 months
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The analysis population includes all randomized participants. Participants were analyzed in the treatment group to which they are randomized.
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0004
    source section id
    NCT05116189-om-0004
    source outcome index
    4
    endpoint
    Overall Survival (OS)
    endpoint definition
    OS is defined as the time from the date of randomization to death due to any cause. The OS will be reported for all participants.
    time origin
    Up to ~64 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0005
    source section id
    NCT05116189-om-0005
    source outcome index
    5
    endpoint
    Number of Participants Who Experience an Adverse Event (AE)
    endpoint definition
    An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
    time origin
    Up to ~64 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pembrolizumab + Paclitaxel ± Bevacizumab
    regimen
    Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    analyzed count
    234
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05116189-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo + Paclitaxel ± Bevacizumab
    regimen
    Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    analyzed count
    232
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05116189-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pembrolizumab + Paclitaxel ± Bevacizumab
    regimen
    Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    analyzed count
    322
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05116189-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo + Paclitaxel ± Bevacizumab
    regimen
    Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    analyzed count
    321
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05116189-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pembrolizumab + Paclitaxel ± Bevacizumab
    regimen
    Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    analyzed count
    234
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05116189-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo + Paclitaxel ± Bevacizumab
    regimen
    Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    analyzed count
    232
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05116189-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pembrolizumab + Paclitaxel ± Bevacizumab
    regimen
    Participants receive pembrolizumab 400 mg via intravenous (IV) infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    analyzed count
    322
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05116189-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-fallopian-tube-neoplasm
    nct id
    NCT05116189
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo + Paclitaxel ± Bevacizumab
    regimen
    Participants receive placebo via IV infusion on Day 1 of each 6-week cycle for up to 18 cycles (approximately 2 years) PLUS paclitaxel 80 mg/m\^2 via IV infusion on Days 1, 8, and 15 of each 3-week cycle until intolerance or disease progression. Participants who experience severe hypersensitivity reaction to paclitaxel or an adverse event requiring discontinuation of paclitaxel may receive docetaxel (75 mg/m\^2 every 3 weeks \[Q3W\]) after Sponsor consultation. Participants may also receive bevacizumab 10 mg/kg via IV infusion of each 2-week cycle until intolerance, disease progression, or at the Investigator's discretion.
    analyzed count
    321
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT05116189-om-0003#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-fallopian-tube-neoplasm
    nct id
    NCT05116189
    harm key
    EG000
    source section id
    NCT05116189-ae
    event group key
    EG000
    event group label
    Pembrolizumab + Paclitaxel ± Bevacizumab
    serious affected
    178
    serious at risk
    320
    other affected
    319
    other at risk
    320
    frequency threshold
    5
    collection period
    Up to approximately 38 months
    event definition
    All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    harm key
    EG001
    source section id
    NCT05116189-ae
    event group key
    EG001
    event group label
    Placebo + Paclitaxel ± Bevacizumab
    serious affected
    122
    serious at risk
    318
    other affected
    307
    other at risk
    318
    frequency threshold
    5
    collection period
    Up to approximately 38 months
    event definition
    All-Cause Mortality: all randomized participants. Serious \& Other AEs: all randomized participants who received ≥1 dose of study treatment and are included in treatment group related to study treatment received. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs.
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    qol key
    qol-0007
    source section id
    NCT05116189-om-0007
    source outcome index
    7
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in Global Health Status/Quality of Life (GHS/Qol) Score (Items 29 and 30) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
    measure definition
    The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
    time frame
    Baseline and up to ~64 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    1
    direction quote
    higher score indicates a better
    population 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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    qol key
    qol-0008
    source section id
    NCT05116189-om-0008
    source outcome index
    8
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Time to Deterioration (TTD) in the GHS/Qol Score (Items 29 and 30) Using the EORTC QLQ-C30
    measure definition
    TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C30 Items 29 and 30) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
    time frame
    Up to ~64 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    qol key
    qol-0009
    source section id
    NCT05116189-om-0009
    source outcome index
    9
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Change From Baseline in the Abdominal and Gastrointestinal (GI) Symptoms Score (Items 31 to 36) Using the EORTC Quality of Life Questionnaire-Ovarian Cancer (QLQ-OV28) Abdominal/GI Symptom Scale
    measure definition
    The EORTC QLQ-OV28 is an abdominal and gastrointestinal questionnaire (items 31-36). Participant responses to the question "Did you have abdominal pain ?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in abdominal and gastrointestinal symptoms (EORTC QLQ-LC28 Items 31-36) score will be presented. A lower score indicates a better outcome.
    time frame
    Baseline and up to ~64 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    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-fallopian-tube-neoplasm
    nct id
    NCT05116189
    qol key
    qol-0010
    source section id
    NCT05116189-om-0010
    source outcome index
    10
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    TTD in the Abdominal and GI Symptoms Score (Items 31 to 36) Using the EORTC QLQ-OV28 Abdominal/GI Symptom Scale
    measure definition
    TTD is defined as the time from Baseline to the first onset of a ≥10-point negative change (decrease) from Baseline in GHS (EORTC QLQ-C28 Items 31-36) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from Baseline in GHS score, will be presented. A longer TTD indicates a better outcome.
    time frame
    Up to ~64 months
    analysis role
    secondary
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    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