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NCT03146650 · OUTCOME

Response Rate (RR)

Nivolumab and Ipilimumab in Treating Patients With Metastatic/Recurrent ACC of All Sites and Non-ACC Salivary Gland Cancer · Source last updated 2024-01-18

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

Measure
NUMBER
Unit
percent of participants
Interval / dispersion
95% Confidence Interval
Time frame
On Cycle 2 Day 1, and every cycle thereafter (1 cycle = 12 weeks), about 27 months

What was measured

Response rate (RR) is percentage of patients whose cancer shrinks or disappears after treatment. Patients with adenoid cystic carcinoma who have a complete response (CR) or partial response (PR) per RECIST criteria v. 1.1 will be included in the results. Per RECIST v. 1.1, CR is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm." A PR is defined as "At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."

Analysis population: Adenoid Cystic Carcinoma (ACC) patient only.

Groups in this outcome

Nivolumab + Ipilimumab

Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).

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

Analysis denominator · Participants

GroupSource count
Nivolumab + Ipilimumab18

Reported measurements

Source class 1
Values in percent of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab + Ipilimumab.06Not reported0.01.26Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.01
        upper Limit
        .26
        value
        .06
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    units
    Participants
description
Response rate (RR) is percentage of patients whose cancer shrinks or disappears after treatment. Patients with adenoid cystic carcinoma who have a complete response (CR) or partial response (PR) per RECIST criteria v. 1.1 will be included in the results. Per RECIST v. 1.1, CR is defined as "disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm." A PR is defined as "At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters."
dispersion Type
95% Confidence Interval
groups
  1. description
    Nivolumab and ipilimumab combination will be administered intravenously until disease progression or intolerable toxicity. Nivolumab: Given at 240mg over 30 minutes (-5 / +15 minutes) every 2 weeks starting with Cycle 1 Day 1 for the first 16 weeks (1 cycle = 12 weeks). Starting with Cycle 2 Day 29, nivolumab will be given at 480mg IV over 60 minutes (-10 / +15 minutes) every 4 weeks. Ipilimumab: Given at 1mg/Kg every 6 weeks starting with Cycle 1 Day 1 over approximately 90 minutes (-5 / +15 minutes). On days when both nivolumab and ipilimumab are administered, nivolumab should be given first, followed by ipilimumab about 30 minutes after completion of nivolumab. Patients will be assessed for response every 12 weeks (±7 days).
    id
    OG000
    title
    Nivolumab + Ipilimumab
param Type
NUMBER
population Description
Adenoid Cystic Carcinoma (ACC) patient only.
reporting Status
POSTED
time Frame
On Cycle 2 Day 1, and every cycle thereafter (1 cycle = 12 weeks), about 27 months
title
Response Rate (RR)
type
SECONDARY
unit Of Measure
percent of participants

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

Preserved source evidence · Not medical advice