NCT03146650 · OUTCOME

Clinical Benefit Rate (CBR)

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

Clinical Benefit Rate (CBR) is defined as the percentage of patients with Complete Response (CR), Partial Response (PR), and Stable Disease (SD) and will be assessed by RECIST 1.1 in patients with adenoid cystic carcinoma (ACC). 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." 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." SD is defined as, "Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."

Analysis population: Patients with Adenoid cystic carcinoma 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

Group	Source count
Nivolumab + Ipilimumab	18

Reported measurements

Source class 1

Values in percent of participants · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Nivolumab + Ipilimumab	0.71	Not reported	0.47	.87	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.47
upper Limit
.87
value
0.71

denoms

counts
group Id
OG000
value
18
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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

Patients with Adenoid cystic carcinoma only.

reporting Status

POSTED

time Frame

On Cycle 2 Day 1, and every cycle thereafter (1 cycle = 12 weeks), about 27 months

title

Clinical Benefit Rate (CBR)

type

SECONDARY

unit Of Measure

percent of participants

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

Preserved source evidence · Not medical advice