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NCT02764593 · ClinicalTrials.gov registry record · Phase 1
Safety Testing of Adding Nivolumab to Chemotherapy in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Cancer
A Phase 1 study, sponsored by RTOG Foundation.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT02764593: Completed Phase 1 study, sponsored by RTOG Foundation.
NCT02764593 is a Phase 1 study that has completed, run by RTOG Foundation. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02764593, a Phase 1 study, has completed, sponsored by RTOG Foundation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This study will evaluate the safety of adding nivolumab to several chemotherapy platforms with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone.
Primary Outcome
A nivolumab attributable, dose-limiting toxicity (DLT) will be defined as follows: 1\) Any ≥ grade 3 adverse event (CTCAE, v. 4) that is related to nivolumab that does not resolve to grade 1 or less within 28 days; 2) A delay in radiotherapy of \> 2 weeks due to toxicity related to nivolumab; 3) Inability to complete radiotherapy due to toxicity related to nivolumab; 4) Inability to receive an adequate dose (≥ 70%) of cisplatin (Arm 1 and 2) or cetuximab (Arm 3) due to toxicity definitely relat
Interventions
- DRUG Cisplatin
- DRUG Nivolumab
- DRUG Cetuximab
- RADIATION IMRT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-06 |
| Est. Completion | 2022-02-21 |
| Phase | Phase 1 |
What the finished NCT02764593 record still lists
NCT02764593 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Cisplatin is the first listed.
NCT02764593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02764593 about?
NCT02764593 is a clinical study titled "Safety Testing of Adding Nivolumab to Chemotherapy in Patients With Intermediate and High-Risk Local-Regionally Advanced Head and Neck Cancer". This study will evaluate the safety of adding nivolumab to several chemotherapy platforms with weekly cisplatin, high-dose cisplatin, cetuximab or radiation therapy alone.
What is the current status of trial NCT02764593?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2016-06. Estimated completion is 2022-02-21.
What interventions are being tested in trial NCT02764593?
The interventions under investigation include: Cisplatin (DRUG), Nivolumab (DRUG), Cetuximab (DRUG), IMRT (RADIATION).
Who is sponsoring clinical trial NCT02764593?
This trial is sponsored by RTOG Foundation, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02764593's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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