NCT03254927 · OUTCOME

Duration of Response (DOR)

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: NUMBER
Unit: months
Interval / dispersion: Not reported
Time frame: First occurrence of a documented objective response to disease progression or death (up to approximately 2 years)

What was measured

The interval from which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) until the first date that progressive disease is objectively documented

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

Group	Source count
CDX-3379 and Cetuximab	30

Reported measurements

Source class 1

Values in months · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
CDX-3379 and Cetuximab	NA	Not reported	Not reported	Not reported	30 patients were treated, 2 patients achieved objective response. The duration of response was 5 months and 18.7 months for the 2 patients who achieved objective response.

Complete source fields

classes

categories
measurements
comment
30 patients were treated, 2 patients achieved objective response. The duration of response was 5 months and 18.7 months for the 2 patients who achieved objective response.
group Id
OG000
value
NA

denoms

counts
group Id
OG000
value
30
units
Participants

description

The interval from which measurement criteria are first met for Complete Response (CR) or Partial Response (PR) until the first date that progressive disease is objectively documented

groups

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

NUMBER

reporting Status

POSTED

time Frame

First occurrence of a documented objective response to disease progression or death (up to approximately 2 years)

title

Duration of Response (DOR)

type

SECONDARY

unit Of Measure

months

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

Preserved source evidence · Not medical advice