Phase II Randomized, Placebo- Controlled 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
NCT06561087
Phase
PHASE2
Status
Recruiting
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Conditions

  • Premalignant Lesion

Eligibility Criteria

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

Interventions

Study Details

To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions

Key Dates

Start date
Feb 27, 2025
Status verified
Feb 2026
Primary completion
May 30, 2027
Completion
May 30, 2029

Study Design

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

Arms

  • Experimental: Nivolumab/Placebo
    Participants will be screened for LOH and randomly assigned to trial

Primary Outcome Measure

Safety and AdverseEevents (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77090
Moran Amit, MD,PHD
[email protected]
713-794-5304
Moran Amit, MD,PHD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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