Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06561087 · ClinicalTrials.gov registry record · Phase 2
Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions
A Phase 2 study of Premalignant Lesion, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 1
- Study location
NCT06561087: Recruiting Phase 2 study of Premalignant Lesion, sponsored by M.D. Anderson Cancer Center.
NCT06561087 is a Phase 2 study of Premalignant Lesion that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 45 participants, below the 232-participant average among 4 other Premalignant Lesion trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06561087, a Phase 2 study of Premalignant Lesion, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 1
- Study location
Study Summary
To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
Primary Outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Conditions Studied
Interventions
- DRUG Nivolumab
Study Locations (1)
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2025-02-27 |
| Est. Completion | 2029-05-30 |
| Phase | Phase 2 |
What NCT06561087 shows while recruiting
NCT06561087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 232-participant average among 4 other Premalignant Lesion trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Premalignant Lesion appearing as the primary indexed condition, and to 1 intervention - of which Nivolumab is the first listed.
NCT06561087 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06561087 about?
NCT06561087 is a clinical study titled "Phase II Randomized, Placebo- Controlled Study of Intralesional Nivolumab for High-risk Oral Premalignant Lesions". To evaluate the antitumor efficacy of intralesional injections of nivolumab in patients with high-risk oral premalignant lesions
What is the current status of trial NCT06561087?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2025-02-27. Estimated completion is 2029-05-30.
What conditions does trial NCT06561087 study?
This clinical trial studies the following conditions: Premalignant Lesion.
What interventions are being tested in trial NCT06561087?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT06561087?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06561087 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Premalignant Lesion
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Detection of Oral and Throat Cancers Using OralViome Cancer Testing System
RECRUITING
-
Multimodal Imaging for Surveillance in Patients With Oral Potentially Malignant Disorders
ACTIVE NOT RECRUITING · Early Phase 1
-
Diabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants
ACTIVE NOT RECRUITING · NA
-
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00804154 · 45 participants · Phase 1
Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer
- NCT01851694 · 45 participants · NA
Beta-cell Response to Incretin Hormones in Cystic Fibrosis
- NCT02896335 · 45 participants · Phase 2
Palbociclib and Pembrolizumab In Central Nervous System Metastases
- NCT03454035 · 45 participants · Phase 1
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI