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NCT03670056 · ClinicalTrials.gov registry record · Phase 2
Ipilimumab and Nivolumab in Recurrent Extensive Stage Small Cell Lung Cancer After Receiving Platinum-based Chemotherapy
A Phase 2 study of Small-cell Lung Cancer, sponsored by Yale University.
- Active
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT03670056: Active Phase 2 study of Small-cell Lung Cancer, sponsored by Yale University.
NCT03670056 is a Phase 2 study of Small-cell Lung Cancer that is active but no longer recruiting, run by Yale University. The registered enrollment target is 25 participants, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03670056, a Phase 2 study of Small-cell Lung Cancer, is active but no longer recruiting, sponsored by Yale University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study of patients who previously received platinum chemotherapy with recurrent SCLC to evaluate the change in the ratio of intratumoral Teff/Treg cells and clinical benefit of treatment with nivolumab and ipilimumab.
Primary Outcome
The primary analysis will use the nonparametric Mann-Whitney sign test to compare the change in the ratio of Teff/Treg cells in those patients who respond or not to treatment. This test compares the rate of response in those with above and below Teff/Treg ratio.
Conditions Studied
Interventions
- DRUG Combination immunotherapy with Ipilimumab and Nivolumab
Study Locations (1)
Connecticut
- Yale University, Yale Cancer Center - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2018-12-06 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What the registry record for NCT03670056 still lists
NCT03670056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 232-participant average among 79 other Small-cell Lung Cancer trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Small-cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which Combination immunotherapy with Ipilimumab and Nivolumab is the first listed.
NCT03670056 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT03670056 about?
NCT03670056 is a clinical study titled "Ipilimumab and Nivolumab in Recurrent Extensive Stage Small Cell Lung Cancer After Receiving Platinum-based Chemotherapy". This is a pilot study of patients who previously received platinum chemotherapy with recurrent SCLC to evaluate the change in the ratio of intratumoral Teff/Treg cells and clinical benefit of treatment with nivolumab and ipilimumab.
What is the current status of trial NCT03670056?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2018-12-06. Estimated completion is 2025-12.
What conditions does trial NCT03670056 study?
This clinical trial studies the following conditions: Small-cell Lung Cancer.
What interventions are being tested in trial NCT03670056?
The interventions under investigation include: Combination immunotherapy with Ipilimumab and Nivolumab (DRUG).
Who is sponsoring clinical trial NCT03670056?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03670056 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Small-cell Lung Cancer
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 NCT03670056's enrollment target sits among peer trials
25 73rd of 79 higher than 6 of 79 other Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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