Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Intralesional Nivolumab for High-risk Oral Premalignant Lesions
NCT06561087Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2025
- Primary completion
- May 2027
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Monoclonal Antibodies
- Drugs
- nivolumab
- Conditions
- oral premalignant lesion (OPMD)
01
Overview
Phase 2, randomised, double-blind trial in oral premalignant lesion (OPMD) comparing Nivolumab with Placebo (2 arms). Primary endpoints: Safety and Adverse Events at 1 year and Oral cancer free survival. Started Feb 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Nivolumab
Intralesional injections of Nivolumab
Placebo
Intralesional injections of Placebo
03
Who it enrols
Adults with treatment-naive, biopsy-proven, intraoral premalignant lesions visible from the oral cavity, with ECOG PS 0-2 and adequate organ function. Excludes patients with prior anti-neoplastic therapy within 4 weeks, active TB, active non-infectious pneumonitis, or other progressing malignancies.
04
Endpoints
Primary
Safety and Adverse Events
Oral cancer free survival
Secondary
Objective Response Rate
Pathologic Complete Response Rate
Major pathologic response rate
Beyond the preview
Go deeper on NCT06561087.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT06561087.