Trial of Nivolumab as a Novel Neoadjuvant Pre-Surgical Therapy for Locally Advanced Oral Cavity Cancer
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- Medical University of South Carolina
- Study ID
- NCT03021993
- Phase
- PHASE2
- Status
- Completed
Conditions
- Oral Cavity SCC
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nivolumab — DRUGNivolumab will be administered on days 1, 15 and 29. If disease has progressed at day 29, the subject will proceed to surgery. If a response or stable disease is present after the third dose, a fourth dose will be given on day 43, then the subject will proceed to surgery.
Study Details
The purpose of this study is to look at the effectiveness of nivolumab in patients with oral cavity cancer (OCC) who are about to undergo surgery.
Key Dates
- Start date
- May 30, 2017
- Status verified
- Oct 2025
- Primary completion
- Nov 15, 2021
- Completion
- Nov 15, 2021
Study Design
- Enrollment
- 17 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: NivolumabNivolumab (OPDIVO) will be administered every two weeks for up to four doses prior to surgery at 3mg/kg
Primary Outcome Measure
Objective Response Rate Using Pathological Response [ Time Frame: Time of surgery (day 36 or day 50) ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | - |
Related coverage on Hipa.ai
- Nivolumab Trial for Oral Cavity Cancer Shows 4 Pathological ResponsesNivolumab · Nov 12, 2025 · ClinicalTrials.gov
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