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NCT03878979 · ClinicalTrials.gov registry record · Phase 2
Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN
A Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03878979: Completed Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03878979 is a Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 26 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03878979, a Phase 2 study of Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
Nivolumab, also known as (Bristol Myers Squibb (BMS)) BMS-936558, before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).
Primary Outcome
Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug related adverse events as defined by CTCAE v5.0, occurring up to 100 days after the last dose of nivolumab or 30 days after surgery (whichever is longer)
Conditions Studied
Interventions
- DRUG Nivolumab 480mg and surgical resection
Study Locations (1)
Maryland
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-07-08 |
| Est. Completion | 2023-10-17 |
| Phase | Phase 2 |
What the finished NCT03878979 record still lists
NCT03878979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Nivolumab 480mg and surgical resection is the first listed.
NCT03878979 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03878979 about?
NCT03878979 is a clinical study titled "Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN". Nivolumab, also known as (Bristol Myers Squibb (BMS)) BMS-936558, before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).
What is the current status of trial NCT03878979?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2019-07-08. Estimated completion is 2023-10-17.
What conditions does trial NCT03878979 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Head and Neck Cancer Metastatic.
What interventions are being tested in trial NCT03878979?
The interventions under investigation include: Nivolumab 480mg and surgical resection (DRUG).
Who is sponsoring clinical trial NCT03878979?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03878979 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03878979's enrollment target sits among peer trials
26 193rd of 250 higher than 56 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Cancer 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.
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