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NCT02696993 · ClinicalTrials.gov registry record · Phase 1
Nivolumab and Radiation Therapy With or Without Ipilimumab in Treating Patients With Brain Metastases From Non-small Cell Lung Cancer
A Phase 1 study of Metastatic Malignant Neoplasm in the Brain and Stage IV Non-Small Cell Lung Cancer AJCC v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT02696993: Active Phase 1 study of Metastatic Malignant Neoplasm in the Brain and Stage IV Non-Small Cell Lung Cancer AJCC v7, sponsored by M.D. Anderson Cancer Center.
NCT02696993 is a Phase 1 study of Metastatic Malignant Neoplasm in the Brain and Stage IV Non-Small Cell Lung Cancer AJCC v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 80 participants, roughly in line with the 86-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02696993, a Phase 1 study of Metastatic Malignant Neoplasm in the Brain and Stage IV Non-Small Cell Lung Cancer AJCC v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of nivolumab when giving together with stereotactic radiosurgery or whole brain radiotherapy with or without ipilimumab and to see how well they work in treating patients with non-small cell lung cancer that has spread to the brain. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Radiation therapy, such as whole-brain radiotherapy, uses high energy x-rays to kill tumor cells and shrink tumors. Giving nivolumab together with stereotactic radiosurgery or whole brain radiotherapy with or without ipilimumab may work better in treating patients with non-small cell lung cancer that has spread to the brain.
Primary Outcome
Assessed using a Bayesian model.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Nivolumab
- RADIATION Stereotactic Radiosurgery
- PROCEDURE Cognitive Assessment
- BIOLOGICAL Ipilimumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2016-12-16 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT02696993 still lists
NCT02696993 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, roughly in line with the 86-participant average among 43 other Metastatic Malignant Neoplasm in the Brain trials with a reported enrollment target.
The record links to 2 conditions, with Metastatic Malignant Neoplasm in the Brain appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02696993 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02696993 about?
NCT02696993 is a clinical study titled "Nivolumab and Radiation Therapy With or Without Ipilimumab in Treating Patients With Brain Metastases From Non-small Cell Lung Cancer". This phase I/II trial studies the side effects and best dose of nivolumab when giving together with stereotactic radiosurgery or whole brain radiotherapy with or without ipilimumab and to see how well they work in treating patients with non-small cell lung cancer that has spread to the brain. Monocl...
What is the current status of trial NCT02696993?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 80 participants. The study started on 2016-12-16. Estimated completion is 2027-12-31.
What conditions does trial NCT02696993 study?
This clinical trial studies the following conditions: Metastatic Malignant Neoplasm in the Brain, Stage IV Non-Small Cell Lung Cancer AJCC v7.
What interventions are being tested in trial NCT02696993?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Nivolumab (BIOLOGICAL), Stereotactic Radiosurgery (RADIATION), Cognitive Assessment (PROCEDURE), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02696993?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02696993 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02696993's enrollment target sits among peer trials
80 17th of 43 higher than 27 of 43 other Metastatic Malignant Neoplasm in the Brain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Neoplasm in the Brain 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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