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NCT03342911 · OUTCOME

Pathologic Complete Response Rate

Nivolumab, Carboplatin, and Paclitaxel in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma That Can Be Removed by Surgery · Source last updated 2025-04-24

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

Measure
NUMBER
Unit
percentage of complete response
Interval / dispersion
95% Confidence Interval
Time frame
Up to 26 months

What was measured

The primary objective of the study is to estimate the rate of pathologic complete response (pCR) at the primary site, defined as the absence of any residual invasive cancer on H\&E evaluation of the resected specimen and all sampled ipsilateral lymph nodes, in patients with newly diagnosed and untreated Stage III-IVA SCCHN of the oral cavity, Oropharynx, Larynx, and Hypopharynx treated with standard neoadjuvant chemotherapy plus Nivolumab, paclitaxel, and carboplatin. Pathologic complete response rate and its associated score 95% confidence interval will be estimated.

Analysis population: The complete pathologic response rate was 45.45% (15/33) with a 95% Confidence Interval of 28.5% to 63.4%.

Groups in this outcome

Treatment (Nivolumab, Paclitaxel, Carboplatin)

Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV

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

Analysis denominator · Participants

GroupSource count
Treatment (Nivolumab, Paclitaxel, Carboplatin)33

Reported measurements

Source class 1
Values in percentage of complete response · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Nivolumab, Paclitaxel, Carboplatin)45.5Not reported28.563.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        28.5
        upper Limit
        63.4
        value
        45.5
denoms
  1. counts
    1. group Id
      OG000
      value
      33
    units
    Participants
description
The primary objective of the study is to estimate the rate of pathologic complete response (pCR) at the primary site, defined as the absence of any residual invasive cancer on H\&E evaluation of the resected specimen and all sampled ipsilateral lymph nodes, in patients with newly diagnosed and untreated Stage III-IVA SCCHN of the oral cavity, Oropharynx, Larynx, and Hypopharynx treated with standard neoadjuvant chemotherapy plus Nivolumab, paclitaxel, and carboplatin. Pathologic complete response rate and its associated score 95% confidence interval will be estimated.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive nivolumab IV over at least 30 minutes on day 1, paclitaxel IV on days 1 and 8, and carboplatin IV on days 1 and 8. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Paclitaxel: Given IV Carboplatin: Given IV Nivolumab: Given IV
    id
    OG000
    title
    Treatment (Nivolumab, Paclitaxel, Carboplatin)
param Type
NUMBER
population Description
The complete pathologic response rate was 45.45% (15/33) with a 95% Confidence Interval of 28.5% to 63.4%.
reporting Status
POSTED
time Frame
Up to 26 months
title
Pathologic Complete Response Rate
type
PRIMARY
unit Of Measure
percentage of complete response

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice