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NCT03181308 · ClinicalTrials.gov registry record · Phase 1
Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC
A Phase 1 study, sponsored by Tracon Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
NCT03181308: Completed Phase 1 study, sponsored by Tracon Pharmaceuticals.
NCT03181308 is a Phase 1 study that has completed, run by Tracon Pharmaceuticals. The registered enrollment target is 11 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03181308, a Phase 1 study, has completed, sponsored by Tracon Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, nonrandomized, dose-escalation, Phase 1b study of carotuximab in combination with standard dose nivolumab in patients with NSCLC that has progressed on or after platinum-based chemotherapy or PD-1/PD-L1 checkpoint inhibition, as a single agent or with chemotherapy.
Primary Outcome
For DLT evaluation, severity (grade) was classified according to common terminology criteria for adverse events version 4.03 (CTCAE v4.03). DLTs were defined as grade 4 neutropenia persisting for ≥ 5 days, Febrile neutropenia: Grade 4 neutropenia with fever \>38.5ºC both sustained over a ≥24-hour period, neutropenic infection (grade ≥ 3 neutropenia with grade ≥ 3 infection), anemia ≥ grade 4, Grade ≥4 thrombocytopenia or Grade ≥3 thrombocytopenia with Grade ≥3 hemorrhage, or grade 3 or 4 nonhema
Interventions
- DRUG OPDIVO
- DRUG Carotuximab (TRC105)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-11-09 |
| Est. Completion | 2019-07-22 |
| Phase | Phase 1 |
What the finished NCT03181308 record still lists
NCT03181308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which OPDIVO is the first listed.
NCT03181308 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03181308 about?
NCT03181308 is a clinical study titled "Study of Carotuximab (TRC105) Plus Nivolumab in Patients With Metastatic NSCLC". This is a multi-center, open-label, nonrandomized, dose-escalation, Phase 1b study of carotuximab in combination with standard dose nivolumab in patients with NSCLC that has progressed on or after platinum-based chemotherapy or PD-1/PD-L1 checkpoint inhibition, as a single agent or with chemotherapy...
What is the current status of trial NCT03181308?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2017-11-09. Estimated completion is 2019-07-22.
What interventions are being tested in trial NCT03181308?
The interventions under investigation include: OPDIVO (DRUG), Carotuximab (TRC105) (DRUG).
Who is sponsoring clinical trial NCT03181308?
This trial is sponsored by Tracon Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03181308's enrollment target sits among peer trials
11 1911th of 2000 higher than 88 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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