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NCT03168464 · ClinicalTrials.gov registry record · Phase 1
Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632)
A Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT03168464: Clinical Trial Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT03168464 is a Phase 1 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03168464, a Phase 1 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
NSCLC patients with metastatic disease who have failed at least one prior treatment and have a minimum of two metastatic lesions (at least one measurable), are eligible if they have an ECOG Performance Status of 0-1. Patients will receive on Day 1, ipilimumab (every 6 weeks) concurrently with radiation (6Gy x 5 fractions). Nivolumab (every 2 weeks) will be given in addition to ipilimumab on day 22.
Primary Outcome
To enhance the ORR to the combination of Ipi/Nivo in chemo-refractory NSCLC by preceding it with a combination of Ipi/RT to convert the irradiated tumor into an in situ vaccine and to double the ORR of Ipi/RT, from 18% based on intent to treat to 36%.
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- RADIATION Radiation therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2017-10-09 |
| Est. Completion | 2022-03-11 |
| Phase | Phase 1 |
Why NCT03168464 stopped before completion
NCT03168464 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT03168464 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03168464 about?
NCT03168464 is a clinical study titled "Radiation and Immune Checkpoints Blockade in Metastatic NSCLC (BMS # CA209-632)". NSCLC patients with metastatic disease who have failed at least one prior treatment and have a minimum of two metastatic lesions (at least one measurable), are eligible if they have an ECOG Performance Status of 0-1. Patients will receive on Day 1, ipilimumab (every 6 weeks) concurrently with radiat...
What is the current status of trial NCT03168464?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2017-10-09. Estimated completion is 2022-03-11.
What interventions are being tested in trial NCT03168464?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT03168464?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03168464's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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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