Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03254927 · OUTCOME

Tumor DNA Biomarkers.

A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma · Source last updated 2023-04-03

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Tumor tissue is obtained during screening window via single biopsy procedure.

What was measured

Tumor DNA biomarkers will be evaluated and assessed for correlation with clinical efficacy. Objective response rate for subset of patients with FAT1 positive tumor is reported.

Analysis population: patients with FAT1 positive tumors

Groups in this outcome

CDX-3379 and Cetuximab

During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.

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

Analysis denominator · Participants

GroupSource count
CDX-3379 and Cetuximab10

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
CDX-3379 and Cetuximab1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Tumor DNA biomarkers will be evaluated and assessed for correlation with clinical efficacy. Objective response rate for subset of patients with FAT1 positive tumor is reported.
groups
  1. description
    During the treatment phase of the study, eligible patients will receive assigned treatments in 3 week cycles until progression. CDX-3379 and cetuximab: Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
    id
    OG000
    title
    CDX-3379 and Cetuximab
param Type
COUNT_OF_PARTICIPANTS
population Description
patients with FAT1 positive tumors
reporting Status
POSTED
time Frame
Tumor tissue is obtained during screening window via single biopsy procedure.
title
Tumor DNA Biomarkers.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice