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NCT02741570 · OUTCOME

Progression Free Survival (PFS)

Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-09-21

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
From randomization to disease progression or death (Up to approximately 65 months)

What was measured

PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-Meier Estimates) Progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Analysis population: All randomized participants and randomized PD-L1 CPS \>= 20 participants

Groups in this outcome

Nivolumab + Ipilimumab

Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.

EXTREME Regimen

Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

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

Analysis denominator · Participants

GroupSource count
Nivolumab + Ipilimumab472
EXTREME Regimen475

Reported measurements

Randomized participants

Analysis denominator · Participants

GroupSource count
Nivolumab + Ipilimumab472
EXTREME Regimen475
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab3.29Not reported2.834.17Not reported
EXTREME Regimen6.77Not reported5.787.00Not reported
Randomized PD-L1 CPS >= 20 participants

Analysis denominator · Participants

GroupSource count
Nivolumab + Ipilimumab185
EXTREME Regimen178
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab5.39Not reported3.096.93Not reported
EXTREME Regimen6.97Not reported5.788.67Not reported

Source statistical analyses

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

  1. ci Lower Limit
    1.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.63
    estimate Comment
    All Randomized Participants
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.40
  2. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.30
    estimate Comment
    All Randomized PD-L1 CPS \>= 20 Participants
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.00
Complete source fields
analyses
  1. ci Lower Limit
    1.19
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.63
    estimate Comment
    All Randomized Participants
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.40
  2. ci Lower Limit
    0.77
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.30
    estimate Comment
    All Randomized PD-L1 CPS \>= 20 Participants
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    param Type
    Cox Proportional Hazard
    param Value
    1.00
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.83
        upper Limit
        4.17
        value
        3.29
      2. group Id
        OG001
        lower Limit
        5.78
        upper Limit
        7.00
        value
        6.77
    denoms
    1. counts
      1. group Id
        OG000
        value
        472
      2. group Id
        OG001
        value
        475
      units
      Participants
    title
    Randomized participants
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.09
        upper Limit
        6.93
        value
        5.39
      2. group Id
        OG001
        lower Limit
        5.78
        upper Limit
        8.67
        value
        6.97
    denoms
    1. counts
      1. group Id
        OG000
        value
        185
      2. group Id
        OG001
        value
        178
      units
      Participants
    title
    Randomized PD-L1 CPS >= 20 participants
denoms
  1. counts
    1. group Id
      OG000
      value
      472
    2. group Id
      OG001
      value
      475
    units
    Participants
description
PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-Meier Estimates) Progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
    id
    OG000
    title
    Nivolumab + Ipilimumab
  2. description
    Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
    id
    OG001
    title
    EXTREME Regimen
param Type
MEDIAN
population Description
All randomized participants and randomized PD-L1 CPS \>= 20 participants
reporting Status
POSTED
time Frame
From randomization to disease progression or death (Up to approximately 65 months)
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice