Trial · NCT03749460
Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers
NCT03749460, Phase 1, Phase 2, Completed, University of Washington; results first posted 2023-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers. Trials, record NCT03749460. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03749460
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers
- NCT number
- NCT03749460
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Lung, Salivary Gland Carcinoma, Stage IV Major Salivary Gland Cancer AJCC v8, Stage IVA Major Salivary Gland Cancer AJCC v8, Stage IVB Major Salivary Gland Cancer AJCC v8, Stage IVC Major Salivary Gland Cancer AJCC v8
- Interventions
- Nivolumab, Ipilimumab, Stereotactic Body Radiation Therapy
- First posted
- 2018-11-21
- Last updated
- 2023-12-29
- Results first posted
- 2023-12-29
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | From start of treatment through up to 100 days after the completion of study treatment (up to 16 months total) | Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 5.0 |
| Secondary | Objective Response Rate (ORR) | Up to 4 years | 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. |
| Secondary | Progression-free Survival (PFS) | From the date of study enrollment, until disease progression or death, assessed up to 4 years | 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 |
| Secondary | Overall Survival (OS) | From the date of study enrollment, until disease progression or death, assessed up to 4 years | OS estimate will be calculated using the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | From start of treatment through up to 100 days after the completion of study treatment (up to 16 months total) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Objective Response Rate (ORR) | Up to 4 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival (PFS) | From the date of study enrollment, until disease progression or death, assessed up to 4 years | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | From the date of study enrollment, until disease progression or death, assessed up to 4 years | months | MEDIAN |
Source ClinicalTrials.gov
Results by group132
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Adrenal Insufficiency | 3 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Allergic Reaction | 1 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Anemia | 2 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Anorexia | 6 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Anxiety | 2 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Arthralgia | 2 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Arthritis | 2 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Aspirational Pneumonitis | 1 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Hyperthyroidism | 1 | Participants | |
| Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 | Treatment (Nivolumab, Ipilimumab, SBRT) | Back Pain | 2 | Participants |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Nivolumab, Ipilimumab, SBRT) | 20 | |
| Overall Study | COMPLETED | Treatment (Nivolumab, Ipilimumab, SBRT) | 20 | |
| Overall Study | NOT COMPLETED | Treatment (Nivolumab, Ipilimumab, SBRT) | 0 |
Source ClinicalTrials.gov
Adverse events131
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 4 | 20 | 7 |
| other | Adrenal Insufficiency | Endocrine disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 3 | 20 | 3 |
| other | Allergic Reaction | Immune system disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 1 | 20 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 2 | 20 | 2 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 6 | 20 | 6 |
| other | Anxiety | Psychiatric disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 2 | 20 | 2 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 2 | 20 | 2 |
| other | Arthritis | Musculoskeletal and connective tissue disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 2 | 20 | 2 |
| other | Aspirational Pneumonia | Respiratory, thoracic and mediastinal disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 1 | 20 | 1 |
| other | Hyperthyroidism | Endocrine disorders | Treatment (Nivolumab, Ipilimumab, SBRT) | 1 | 20 | 1 |
1 to 10 of 131Source ClinicalTrials.gov
See all 131 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Nivolumab, Ipilimumab, SBRT) | 9 | 20 |
| Total, other adverse events | Treatment (Nivolumab, Ipilimumab, SBRT) | 20 | 20 |
| Total, serious adverse events | Treatment (Nivolumab, Ipilimumab, SBRT) | 3 | 20 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03749460
GET https://conductscience.org/api/trials/v1/NCT03749460/results?page=2