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NCT03468218 · OUTCOME

Overall Response Rate (ORR)

Pembrolizumab & Cabozantinib in Patients With Head and Neck Squamous Cell Cancer · Source last updated 2026-01-23

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Up to 2 years after treatment start

What was measured

Will assess the proportion of subjects with partial response or complete response as defined by Response Evaluation Criteria in Solid Tumors version 1.1 response criteria. ORR will be calculated with 95% confidence interval by binomial distribution. The ability of biomarkers to predict ORR will be estimated by chi-square test and/or logistic regression model.

Groups in this outcome

Treatment (Pembrolizumab, Cabozantinib)

Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given PO Pembrolizumab: 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 (Pembrolizumab, Cabozantinib)36

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab, Cabozantinib)52Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        52
denoms
  1. counts
    1. group Id
      OG000
      value
      36
    units
    Participants
description
Will assess the proportion of subjects with partial response or complete response as defined by Response Evaluation Criteria in Solid Tumors version 1.1 response criteria. ORR will be calculated with 95% confidence interval by binomial distribution. The ability of biomarkers to predict ORR will be estimated by chi-square test and/or logistic regression model.
groups
  1. description
    Patients receive pembrolizumab IV over 30 minutes on day 1 and cabozantinib PO QD on days 1-21. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cabozantinib: Given PO Pembrolizumab: Given IV
    id
    OG000
    title
    Treatment (Pembrolizumab, Cabozantinib)
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 2 years after treatment start
title
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice