NCT03749460 · OUTCOME

Objective Response Rate (ORR)

Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers · Source last updated 2023-12-29

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: Up to 4 years

What was measured

Clinical responses to the combination of nivolumab, ipilimumab and hypofractionated radiation will be based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Groups in this outcome

Treatment (Nivolumab, Ipilimumab, SBRT)

Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV Ipilimumab: Given IV Stereotactic Body Radiation Therapy: Undergo SBRT

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
Treatment (Nivolumab, Ipilimumab, SBRT)	20

Reported measurements

Source class 1

Stable Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nivolumab, Ipilimumab, SBRT)	6	Not reported	Not reported	Not reported	Not reported

Progressive Disease

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nivolumab, Ipilimumab, SBRT)	10	Not reported	Not reported	Not reported	Not reported

Partial Response

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (Nivolumab, Ipilimumab, SBRT)	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
6
title
Stable Disease
measurements
group Id
OG000
value
10
title
Progressive Disease
measurements
group Id
OG000
value
4
title
Partial Response

denoms

counts
group Id
OG000
value
20
units
Participants

description

groups

description
Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 2 weeks for up to 12 courses and then every 4 weeks for an additional 8 courses in the absence of disease progression or unacceptable toxicity. Patients also receive ipilimumab IV over 60 minutes on day 1. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Beginning week 3, patients undergo 3 fractions of stereotactic body radiation therapy every other day in the absence of disease progression or unacceptable toxicity. Nivolumab: Given IV Ipilimumab: Given IV Stereotactic Body Radiation Therapy: Undergo SBRT
id
OG000
title
Treatment (Nivolumab, Ipilimumab, SBRT)

param Type

COUNT_OF_PARTICIPANTS

reporting Status

POSTED

time Frame

Up to 4 years

title

Objective Response Rate (ORR)

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice