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NCT02314169 · OUTCOME

Overall Response Rate: Number of Participants With Response (Part A)

Nivolumab With or Without Ipilimumab in Treating Patients With Refractory Metastatic Anal Canal Cancer · Source last updated 2026-07-31

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

Measure
NUMBER
Unit
percentage of patients with a response
Interval / dispersion
95% Confidence Interval
Time frame
Up to 2 years

What was measured

Responses assessed using computed tomography (CT) scans or magnetic resonance imaging according to standard Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria in order to assess disease progression. Complete Response (CR): Disappearance all target lesions; any pathological lymph nodes reduction in short axis to \< 10 mm (\< 1 cm). Partial Response (PR): \> 30% decrease in sum diameters of target lesions. Progressive Disease (PD): \> 20% increase in sum diameters lesions. (Note: appearance of one or \> new lesions considered progressions). Stable Disease (SD): Neither shrinkage qualify for PR nor increase for PD.

Groups in this outcome

Part A: Nivolumab

This primary outcome measure is assessed from patients enrolled onto Part A of this study.

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

Analysis denominator · Participants

GroupSource count
Part A: Nivolumab37

Reported measurements

Source class 1
Values in percentage of patients with a response · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part A: Nivolumab24Not reported1533Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        15
        upper Limit
        33
        value
        24
denoms
  1. counts
    1. group Id
      OG000
      value
      37
    units
    Participants
description
Responses assessed using computed tomography (CT) scans or magnetic resonance imaging according to standard Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria in order to assess disease progression. Complete Response (CR): Disappearance all target lesions; any pathological lymph nodes reduction in short axis to \< 10 mm (\< 1 cm). Partial Response (PR): \> 30% decrease in sum diameters of target lesions. Progressive Disease (PD): \> 20% increase in sum diameters lesions. (Note: appearance of one or \> new lesions considered progressions). Stable Disease (SD): Neither shrinkage qualify for PR nor increase for PD.
dispersion Type
95% Confidence Interval
groups
  1. description
    This primary outcome measure is assessed from patients enrolled onto Part A of this study.
    id
    OG000
    title
    Part A: Nivolumab
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 2 years
title
Overall Response Rate: Number of Participants With Response (Part A)
type
PRIMARY
unit Of Measure
percentage of patients with a response

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

Preserved source evidence · Not medical advice