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NCT03635567 · STUDY IN CONTEXT

Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic

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

PFS was defined as the time from randomization to the first documented progressive disease (PD) 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, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥1 is presented.

All randomized participants with PD-L1 CPS ≥1 based on the treatment group to which they were randomized.

→

primary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (PD) 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, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.

All randomized participants based on the treatment group to which they were randomized.

→

primary · POSTED

PFS was defined as the time from randomization to the first documented progressive disease (PD) 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, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥10 is presented.

All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were randomized.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥1 is presented.

All randomized participants with PD-L1 CPS ≥1 based on the treatment group to which they were randomized.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants is presented.

All randomized participants based on the treatment group to which they were randomized.

→

primary · POSTED

OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥10 is presented.

All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were randomized.

→

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 · Number of Participants With a 10-point Change From Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Combined Global Score

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-cervical-cancer-mvasi-228add04
nct id
NCT03635567
qol key
qol-0014
source section id
NCT03635567-om-0014
source outcome index
14
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
Number of Participants With a 10-point Change From Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Combined Global Score
measure definition
The EORTC QLQ-C30 is a questionnaire to assess the quality of life of cancer patients. Participant responses to "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) are scored on a 7-point scale (1= Very poor to 7=Excellent). Raw scores are standardized with linear transformation so that scores range from 0-100. A higher combined score indicates a better overall health status. Participant post-baseline scores were classified based on change from baseline, "Improved": a ≥10-point improvement in score and confirmed by the next visit; "Stable": a ≥10-point increase or \<10-point change in score OR a \<10-point change in score and a ≥10-point increase in score at the next visit; or "Deteriorated": a ≥10-point deterioration in score when the criteria for improvement/stability weren't met. Participants who didn't meet "Improved", "Stable", or "Deteriorated" criteria reported as "Other".
time frame
Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Per protocol, all randomized participants who received at least one dose of study treatment and completed at least one EORTC QLQ-C30 assessment were analyzed. Participants with no EORTC QLQ-C30 assessment were not included in the analysis.
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-cervical-cancer-mvasi-228add04
nct id
NCT03635567
trial label
Efficacy and Safety Study of First-line Treatment With Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy in Women With Persistent, Recurrent, or Metastatic
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
3
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0000
    source section id
    NCT03635567-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 Investigator in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
    endpoint definition
    PFS was defined as the time from randomization to the first documented progressive disease (PD) 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, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥1 is presented.
    time origin
    Up to approximately 46 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants with PD-L1 CPS ≥1 based on the treatment group to which they were 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-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0001
    source section id
    NCT03635567-om-0001
    source outcome index
    1
    endpoint
    PFS Per RECIST 1.1 as Assessed by Investigator in All Participants
    endpoint definition
    PFS was defined as the time from randomization to the first documented progressive disease (PD) 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, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants is presented.
    time origin
    Up to approximately 46 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants based on the treatment group to which they were 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-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0002
    source section id
    NCT03635567-om-0002
    source outcome index
    2
    endpoint
    PFS Per RECIST 1.1 as Assessed by Investigator in Participants With PD-L1 CPS ≥10
    endpoint definition
    PFS was defined as the time from randomization to the first documented progressive disease (PD) 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, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator for all randomized participants with PD-L1 CPS ≥10 is presented.
    time origin
    Up to approximately 46 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were 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-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0003
    source section id
    NCT03635567-om-0003
    source outcome index
    3
    endpoint
    Overall Survival (OS) in Participants With PD-L1 CPS ≥1
    endpoint definition
    OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥1 is presented.
    time origin
    Up to approximately 46 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants with PD-L1 CPS ≥1 based on the treatment group to which they were 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-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0004
    source section id
    NCT03635567-om-0004
    source outcome index
    4
    endpoint
    OS in All Participants
    endpoint definition
    OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants is presented.
    time origin
    Up to approximately 46 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants based on the treatment group to which they were randomized.
    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-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0005
    source section id
    NCT03635567-om-0005
    source outcome index
    5
    endpoint
    OS in Participants With PD-L1 CPS ≥10
    endpoint definition
    OS was defined as the time from randomization to death due to any cause. The OS for all randomized participants with PD-L1 CPS ≥10 is presented.
    time origin
    Up to approximately 46 months
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All randomized participants with PD-L1 CPS ≥10 based on the treatment group to which they were randomized.
    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-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pembrolizumab+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    analyzed count
    273
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Placebo+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
    analyzed count
    275
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pembrolizumab+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    analyzed count
    308
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Placebo+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
    analyzed count
    309
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pembrolizumab+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    analyzed count
    158
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Placebo+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
    analyzed count
    159
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pembrolizumab+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    analyzed count
    273
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Placebo+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
    analyzed count
    275
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Pembrolizumab+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    analyzed count
    308
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Placebo+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
    analyzed count
    309
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Pembrolizumab+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an intravenous (IV) infusion of pembrolizumab 200 mg for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin Area Under the Curve (AUC) 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity. Eligible participants who stopped the initial course of pembrolizumab with Stable Disease (SD) or better but progressed after discontinuation may have been able to initiate a second course of pembrolizumab for up to 17 cycles (up to approximately 1 additional year) at the investigator's discretion.
    analyzed count
    158
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Placebo+Chemotherapy
    regimen
    On Day 1 of each 21-day cycle, participants received an IV infusion of placebo (Normal Saline or Dextrose solution) for up to 35 cycles (up to approximately 2 years) PLUS Investigator choice of chemotherapy for up to 6 cycles (paclitaxel 175 mg/m\^2 PLUS cisplatin 50 mg/m\^2 WITH or WITHOUT bevacizumab 15 mg/kg per local label OR paclitaxel 175 mg/m\^2 PLUS carboplatin AUC 5 for up to 6 cycles, WITH or WITHOUT bevacizumab 15 mg/kg per local label). All treatments were administered until disease progression or toxicity.
    analyzed count
    159
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03635567-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    harm key
    EG000
    source section id
    NCT03635567-ae
    event group key
    EG000
    event group label
    Pembrolizumab+Chemotherapy
    serious affected
    157
    serious at risk
    307
    other affected
    298
    other at risk
    307
    frequency threshold
    5
    collection period
    Up to approximately 66 months
    event definition
    Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
    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-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    harm key
    EG001
    source section id
    NCT03635567-ae
    event group key
    EG001
    event group label
    Placebo+Chemotherapy
    serious affected
    132
    serious at risk
    309
    other affected
    299
    other at risk
    309
    frequency threshold
    5
    collection period
    Up to approximately 66 months
    event definition
    Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
    undenominated 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-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    harm key
    EG002
    source section id
    NCT03635567-ae
    event group key
    EG002
    event group label
    Pembrolizumab (Second Course)
    serious affected
    4
    serious at risk
    12
    other affected
    8
    other at risk
    12
    frequency threshold
    5
    collection period
    Up to approximately 66 months
    event definition
    Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment are excluded as AEs. Data are reported by treatment received.
    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-cervical-cancer-mvasi-228add04
    nct id
    NCT03635567
    qol key
    qol-0014
    source section id
    NCT03635567-om-0014
    source outcome index
    14
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    Number of Participants With a 10-point Change From Baseline in Quality of Life (QoL) Based on the European Organisation for the Research & Treatment of Cancer (EORTC) QoL Questionnaire-30 (QLQ-C30) Combined Global Score
    measure definition
    The EORTC QLQ-C30 is a questionnaire to assess the quality of life of cancer patients. Participant responses to "How would you rate your overall health during the past week?" (Item 29) and "How would you rate your overall quality of life during the past week?" (Item 30) are scored on a 7-point scale (1= Very poor to 7=Excellent). Raw scores are standardized with linear transformation so that scores range from 0-100. A higher combined score indicates a better overall health status. Participant post-baseline scores were classified based on change from baseline, "Improved": a ≥10-point improvement in score and confirmed by the next visit; "Stable": a ≥10-point increase or \<10-point change in score OR a \<10-point change in score and a ≥10-point increase in score at the next visit; or "Deteriorated": a ≥10-point deterioration in score when the criteria for improvement/stability weren't met. Participants who didn't meet "Improved", "Stable", or "Deteriorated" criteria reported as "Other".
    time frame
    Baseline (Cycle 1 Day 1: Predose) and up to approximately 46 months
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Per protocol, all randomized participants who received at least one dose of study treatment and completed at least one EORTC QLQ-C30 assessment were analyzed. Participants with no EORTC QLQ-C30 assessment were not included in the analysis.
    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