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NCT03370276 · ClinicalTrials.gov registry record · Phase 1
Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT03370276: Completed Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03370276 is a Phase 1 study that has completed, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03370276, a Phase 1 study, has completed, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, investigators want to determine if the combination of Cetuximab and nivolumab can help people with advanced cases of HNSCC. Both cetuximab and nivolumab have been used separately to treat HNSCC and are Food and Drug Administration (FDA) approved in this type of cancer.
Primary Outcome
Maximum Tolerated Dose (MTD).. The target Dose Limiting Toxicity (DLT) rate is \<25%. The MTD will be defined as the dose of cetuximab and nivolumab in which \<1 of 3 patients experience a DLT or \<2 of 6 patients experience a DLT with the next higher dose having at least 2 patients experiencing a DLT. The MTD is the highest dose at which at most 1 of 6 patients has a DLT. This study will utilize the Cancer Therapy Evaluation Program CTCAE version 4.1 for toxicity and event reporting. Dose-limit
Interventions
- DRUG Nivolumab
- DRUG Cetuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2017-12-20 |
| Est. Completion | 2023-12-23 |
| Phase | Phase 1 |
What the finished NCT03370276 record still lists
NCT03370276 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03370276 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03370276 about?
NCT03370276 is a clinical study titled "Cetuximab & Nivolumab in Patients With Recurrent/Metastatic Head & Neck Squamous Cell Carcinoma". The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in participants with Head and Neck Squamous Cell Carcinoma (HNSCC). Specifically, investigators want to determine if the combination of Cetuximab and nivolumab can help people with adv...
What is the current status of trial NCT03370276?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2017-12-20. Estimated completion is 2023-12-23.
What interventions are being tested in trial NCT03370276?
The interventions under investigation include: Nivolumab (DRUG), Cetuximab (DRUG).
Who is sponsoring clinical trial NCT03370276?
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 NCT03370276's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 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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