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NCT03043599 · ClinicalTrials.gov registry record · Phase 1
Ipilimumab + Nivolumab w/Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
NCT03043599 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 21 participants.
The verdict
NCT03043599, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of the safety run in Phase I portion of this study is to confirm the recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of platinum-based chemotherapy. The purpose of the Phase II portion of this study is to estimate the 6-month Progression Free Survival (PFS) rate among participants treated with ipilimumab and nivolumab with thoracic radiation therapy (30 Gy in 10 fractions) after standard treatment with 4 to 6 cycles of platinum based chemotherapy.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- RADIATION Thoracic Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-02-13 |
| Est. Completion | 2023-11-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03043599
The ClinicalTrials.gov registry entry for NCT03043599 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03043599 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03043599 about?
NCT03043599 is a clinical study titled "Ipilimumab + Nivolumab w/Thoracic Radiotherapy for Extensive-Stage Small Cell Lung Cancer". The purpose of the safety run in Phase I portion of this study is to confirm the recommended Phase II dose of ipilimumab and nivolumab among participants treated with combined thoracic radiation therapy (30 Gy in 10 fractions) and nivolumab/ipilimumab following standard treatment with 4-6 cycles of ...
What is the current status of trial NCT03043599?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2017-02-13. Estimated completion is 2023-11-16.
What interventions are being tested in trial NCT03043599?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Thoracic Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03043599?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
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