Non-randomized, Open-label Study of Intralesional Nivolumab for High Risk Oral Premalignant Lesions
NCT05327270 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-12-26
Summary
To characterize the safety and tolerability of nivolumab injected intralesionally in patients with high-risk oral premalignant lesions.
Conditions
Interventions
- DRUG
-
Given by IT
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Moran Amit, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-13
- Primary Completion
- 2027-02-02
- Completion
- 2027-02-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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