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NCT02259621 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC
A Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Active
- Registry status
- Phase 2
- Development phase
- 39
- Enrollment target
- 5
- Study locations
NCT02259621: Active Phase 2 study of Non-Small Cell Lung Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT02259621 is a Phase 2 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 39 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02259621, a Phase 2 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 39 participants
- Enrollment target
- 5
- Study locations
Study Summary
The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factors in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.
Primary Outcome
Safety will be measured by drawing safety labs. (CBC and a Chemistry Panel will be drawn at 2 week intervals during Nivolumab administration). Grade 3 and 4 lab abnormalities will be recorded from both participating sites.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Paclitaxel
Study Locations (5)
Maryland
- Johns Hopkins at Bayview Medical Center - Baltimore
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
New York
- Memorial Sloan Kettering - New York
Washington
- Swedish Cancer Insitute - Edmonds
Quebec
- Johnathan Spicer - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2014-09 |
| Est. Completion | 2027-10 |
| Phase | Phase 2 |
What the registry record for NCT02259621 still lists
NCT02259621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT02259621 lists 5 locations in 4 states (Maryland, New York, Washington).
Frequently Asked Questions
What is clinical trial NCT02259621 about?
NCT02259621 is a clinical study titled "Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC". The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factor...
What is the current status of trial NCT02259621?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2014-09. Estimated completion is 2027-10.
What conditions does trial NCT02259621 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT02259621?
The interventions under investigation include: Carboplatin (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT02259621?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02259621 being conducted?
This trial has 5 study locations across Maryland, New York, Washington, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02259621's enrollment target sits among peer trials
39 369th of 454 higher than 83 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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