Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 5.0

Source null

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secondary · POSTED

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.

Source null

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secondary · POSTED

PFS estimate will be calculated using the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion

Source null

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secondary · POSTED

OS estimate will be calculated using the Kaplan-Meier method.

Source null

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id: NCT03749460
trial label: Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 4
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id
NCT03749460
outcome key
om-0000
source section id
NCT03749460-om-0000
source outcome index
0
endpoint
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0
endpoint definition
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 5.0
time origin
From start of treatment through up to 100 days after the completion of study treatment (up to 16 months total)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id
NCT03749460
outcome key
om-0001
source section id
NCT03749460-om-0001
source outcome index
1
endpoint
Objective Response Rate (ORR)
endpoint definition
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.
time origin
Up to 4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id
NCT03749460
outcome key
om-0002
source section id
NCT03749460-om-0002
source outcome index
2
endpoint
Progression-free Survival (PFS)
endpoint definition
PFS estimate will be calculated using the Kaplan-Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion
time origin
From the date of study enrollment, until disease progression or death, assessed up to 4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id
NCT03749460
outcome key
om-0003
source section id
NCT03749460-om-0003
source outcome index
3
endpoint
Overall Survival (OS)
endpoint definition
OS estimate will be calculated using the Kaplan-Meier method.
time origin
From the date of study enrollment, until disease progression or death, assessed up to 4 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id
NCT03749460
outcome key
om-0000
arm key
OG000
arm label
Treatment (Nivolumab, Ipilimumab, SBRT)
regimen
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
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03749460-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id
NCT03749460
outcome key
om-0001
arm key
OG000
arm label
Treatment (Nivolumab, Ipilimumab, SBRT)
regimen
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
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03749460-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id
NCT03749460
outcome key
om-0002
arm key
OG000
arm label
Treatment (Nivolumab, Ipilimumab, SBRT)
regimen
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
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03749460-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id
NCT03749460
outcome key
om-0003
arm key
OG000
arm label
Treatment (Nivolumab, Ipilimumab, SBRT)
regimen
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
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03749460-om-0003#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-stage-ivc-major-salivary-gland-cancer-ajcc-v8
nct id
NCT03749460
harm key
EG000
source section id
NCT03749460-ae
event group key
EG000
event group label
Treatment (Nivolumab, Ipilimumab, SBRT)
serious affected
3
serious at risk
20
other affected
20
other at risk
20
frequency threshold
0
collection period
Up to 4 years
event definition
Adverse events are collected from the first dose of Ipilimumab/Nivolumab, and are collected through 100 days post the last dose of therapy.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice