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NCT02718417 · OUTCOME

Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100) · Source last updated 2020-07-14

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)

What was measured

BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.

Analysis population: The full analysis set included all randomized participants.

Groups in this outcome

Chemotherapy Followed by Avelumab

In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg\*min/mL) x (glomerular filtration rate\[GFR\] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.

Chemotherapy + Avelumab Followed by Avelumab

In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose \[milligrams\](mg) = Target AUC (mg\*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.

Chemotherapy Followed by Observation

In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose \[milligrams\](mg) = Target AUC \[milligrams\*minute per milliliter\] (mg\*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Chemotherapy Followed by Avelumab332
Chemotherapy + Avelumab Followed by Avelumab331
Chemotherapy Followed by Observation335

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Chemotherapy Followed by Avelumab16.8Not reported13.5NAThe upper limit of 95% CI was not estimable due to limited number of events.
Chemotherapy + Avelumab Followed by Avelumab18.1Not reported14.8NAThe upper limit of 95% CI was not estimable due to limited number of events.
Chemotherapy Followed by ObservationNANot reported18.2NAThe median and upper limit of 95% CI was not estimable due to limited number of events.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    1.051
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.946
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.9890
    p Value Comment
    One-sided log-rank test was used.
    param Type
    Hazard Ratio (HR)
    param Value
    1.43
    statistical Comment
    Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.832
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.565
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7935
    p Value Comment
    One-sided log-rank test was used.
    param Type
    Hazard Ratio (HR)
    param Value
    1.14
    statistical Comment
    Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    1.051
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.946
    group Ids
    1. OG000
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.9890
    p Value Comment
    One-sided log-rank test was used.
    param Type
    Hazard Ratio (HR)
    param Value
    1.43
    statistical Comment
    Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
    statistical Method
    Log Rank
  2. ci Lower Limit
    0.832
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.565
    group Ids
    1. OG001
    2. OG002
    non Inferiority Type
    SUPERIORITY
    p Value
    0.7935
    p Value Comment
    One-sided log-rank test was used.
    param Type
    Hazard Ratio (HR)
    param Value
    1.14
    statistical Comment
    Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test.
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of 95% CI was not estimable due to limited number of events.
        group Id
        OG000
        lower Limit
        13.5
        upper Limit
        NA
        value
        16.8
      2. comment
        The upper limit of 95% CI was not estimable due to limited number of events.
        group Id
        OG001
        lower Limit
        14.8
        upper Limit
        NA
        value
        18.1
      3. comment
        The median and upper limit of 95% CI was not estimable due to limited number of events.
        group Id
        OG002
        lower Limit
        18.2
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      332
    2. group Id
      OG001
      value
      331
    3. group Id
      OG002
      value
      335
    units
    Participants
description
BICR assessed PFS: Duration from randomization until disease progression or death. PFS data was censored on the date of the last adequate tumor assessment for participants who did not have an event (progression of disease or death), who started a new anti-cancer therapy prior to an event or for participants with an event after 2 or more missing tumor assessments. Progression as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1: as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of one or more new lesions was also considered progression. Analysis was performed using Kaplan-Meier method.
dispersion Type
95% Confidence Interval
groups
  1. description
    In chemotherapy phase (CP),based on investigator's decision,participants received either:paclitaxel 175 milligrams per square meter (mg/m2) intravenous (IV) infusion,followed by carboplatin dose at area under curve (AUC) 5 or 6,IV infusion (carboplatin dose (mg) = Target AUC (mg\*min/mL) x (glomerular filtration rate\[GFR\] mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 (1 cycle=21 days). After completion of CP, participants without evidence of disease progression, received avelumab 10 mg/kg, over 1 hour IV infusion,once every 2 weeks on Days 1, 15, and 29 (1 cycle=42 days) in maintenance phase (MP) until confirmed progressive disease,unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
    id
    OG000
    title
    Chemotherapy Followed by Avelumab
  2. description
    In CP, based on investigator's decision, participants received either:paclitaxel 175 mg/m2,IV,followed by carboplatin dose at AUC 5 or 6,IV (carboplatin dose \[milligrams\](mg) = Target AUC (mg\*min/mL) x GFR mL/min + 25),and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6;or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6 along with Avelumab 10 mg/kg administered as a 1-hour IV infusion once every 3 weeks for Cycle 1 to 6 ( 1 cycle=21 days).After completion of CP, participants without evidence of disease progression, received Avelumab IV, 10 mg/kg, once every 2 weeks on Days 1, 15, and 29 ( 1 cycle=42 days) in MP until confirmed progressive disease (PD), unacceptable toxicity, or withdrawal of consent, or a maximum duration of 24 months. Participants were then followed up to a maximum of 36 months.
    id
    OG001
    title
    Chemotherapy + Avelumab Followed by Avelumab
  3. description
    In CP, based on investigator's decision, participants received either: paclitaxel 175 mg/m2, IV infusion, followed by carboplatin dose at AUC 5 or 6, IV infusion (carboplatin dose \[milligrams\](mg) = Target AUC \[milligrams\*minute per milliliter\] (mg\*min/mL) x GFR mL/min + 25), and maximum carboplatin dose = target AUC x (150 mL/min) on Day 1 of Cycles 1 to 6; or Paclitaxel 80 mg/m2 IV infusion over 1 hour on Days 1, 8, and 15, along with carboplatin dose at AUC 5 or 6, IV infusion over 1 hour on Day 1 of Cycle 1 to 6. Each cycle was of 21 days (3 weeks). After completion of CP, participants were followed for survival status until death or until study completion, whichever was earlier or a maximum duration of 24 months in observation phase. Participants were then followed up to a maximum of 36 months.
    id
    OG002
    title
    Chemotherapy Followed by Observation
param Type
MEDIAN
population Description
The full analysis set included all randomized participants.
reporting Status
POSTED
time Frame
Baseline to progression of disease or discontinuation from the study or death, whichever occurred first (maximum duration of 27 months)
title
Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)
type
PRIMARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice