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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: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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. Investigators will initially enroll 6 patients and wait until completion of the 13-week safety observation period following initiation of ipilimumab + nivolumab combination treatment.
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 |
What the finished NCT03043599 record still lists
NCT03043599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03043599 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03043599's enrollment target sits among peer trials
21 1615th of 2000 higher than 372 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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