Non-randomized, Open-label Study of Intralesional Nivolumab for High Risk Oral Premalignant Lesions

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05327270
Phase
PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To characterize the safety and tolerability of nivolumab injected intralesionally in patients with high-risk oral premalignant lesions.

Key Dates

Start date
Sep 13, 2022
Status verified
Jun 2026
Primary completion
Feb 2, 2027
Completion
Feb 2, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Nivolumab will be given as an injection directly into an oral lesion.

Primary Outcome Measure

To evaluate the objective response rate (ORR) in index lesions following intralesional injections of nivolumab in patients with high-risk oral premalignant lesions, according to modified World Health Organization (WHO) criteria. [ Time Frame: through study completion, an average of 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
M D Anderson Cancer Center· Houston, TX

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