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NCT03749460 · ClinicalTrials.gov registry record · Phase 1
Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers
A Phase 1 study of Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Neoplasm in the Lung, sponsored by University of Washington.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03749460: Completed Phase 1 study of Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Neoplasm in the Lung, sponsored by University of Washington.
NCT03749460 is a Phase 1 study of Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Neoplasm in the Lung that has completed, run by University of Washington. The registered enrollment target is 20 participants, below the 248-participant average among 16 other Metastatic Malignant Neoplasm in the Bone trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03749460, a Phase 1 study of Metastatic Malignant Neoplasm in the Bone and Metastatic Malignant Neoplasm in the Lung, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and how well nivolumab and ipilimumab works when given together with stereotactic body radiation therapy (SBRT) in treating patients with salivary gland cancers. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving nivolumab and ipilimumab and SBRT may work better in treating patients with advanced salivary gland cancers.
Primary Outcome
Toxicities will be summarized as the number and percentage of patients with each type of toxicity, per Criteria for Adverse Events version 5.0
Conditions Studied
Interventions
- RADIATION Stereotactic Body Radiation Therapy
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-01-15 |
| Est. Completion | 2023-11-05 |
| Phase | Phase 1 |
What the finished NCT03749460 record still lists
NCT03749460 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 248-participant average among 16 other Metastatic Malignant Neoplasm in the Bone trials with a reported enrollment target (92% lower).
The record links to 7 conditions, with Metastatic Malignant Neoplasm in the Bone appearing as the primary indexed condition, and to 3 interventions - of which Stereotactic Body Radiation Therapy is the first listed.
NCT03749460 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT03749460 about?
NCT03749460 is a clinical study titled "Nivolumab and Ipilimumab and Stereotactic Body Radiation Therapy in Treating Patients With Salivary Gland Cancers". This phase I/II trial studies the side effects and how well nivolumab and ipilimumab works when given together with stereotactic body radiation therapy (SBRT) in treating patients with salivary gland cancers. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the bo...
What is the current status of trial NCT03749460?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2019-01-15. Estimated completion is 2023-11-05.
What conditions does trial NCT03749460 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Lung, Stage IV Major Salivary Gland Cancer AJCC v8, Salivary Gland Carcinoma, Stage IVA Major Salivary Gland Cancer AJCC v8.
What interventions are being tested in trial NCT03749460?
The interventions under investigation include: Stereotactic Body Radiation Therapy (RADIATION), Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03749460?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03749460 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03749460's enrollment target sits among peer trials
20 15th of 16 higher than 1 of 16 other Metastatic Malignant Neoplasm in the Bone trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Neoplasm in the Bone trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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