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NCT02741570 · OUTCOME

Objective Response Rate (ORR)

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
NUMBER
Unit
Percent
Interval / dispersion
95% Confidence Interval
Time frame
From randomization up to approximately 65 months

What was measured

Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

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

All randomized participants

Analysis denominator · Participants

GroupSource count
Nivolumab + Ipilimumab472
EXTREME Regimen475
Values in Percent · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab24.2Not reported20.428.3Not reported
EXTREME Regimen37.1Not reported32.741.6Not reported
Randomized PD-L1 CPS >= 20 participants

Analysis denominator · Participants

GroupSource count
Nivolumab + Ipilimumab185
EXTREME Regimen178
Values in Percent · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab34.1Not reported27.341.4Not reported
EXTREME Regimen35.4Not reported28.442.9Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.4
        upper Limit
        28.3
        value
        24.2
      2. group Id
        OG001
        lower Limit
        32.7
        upper Limit
        41.6
        value
        37.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        472
      2. group Id
        OG001
        value
        475
      units
      Participants
    title
    All randomized participants
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        27.3
        upper Limit
        41.4
        value
        34.1
      2. group Id
        OG001
        lower Limit
        28.4
        upper Limit
        42.9
        value
        35.4
    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
Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
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
NUMBER
population Description
All randomized participants and randomized PD-L1 CPS \>= 20 participants
reporting Status
POSTED
time Frame
From randomization up to approximately 65 months
title
Objective Response Rate (ORR)
type
SECONDARY
unit Of Measure
Percent

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

Preserved source evidence · Not medical advice