Trial · NCT04504552
Immune Checkpoint Inhibitor In High Risk Oral Premalignant Lesions
NCT04504552, Phase 2, Unknown, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Immune Checkpoint Inhibitor In High Risk Oral Premalignant Lesions. Trials, record NCT04504552. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04504552
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Immune Checkpoint Inhibitor In High Risk Oral Premalignant Lesions
- NCT number
- NCT04504552
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 240 participants, estimated
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Conditions
- Oral Premalignant Lesions
- Interventions
- Avelumab
- First posted
- 2020-08-07
- Last updated
- 2020-12-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recurrence-free survival or malignant transformation-free survival | Every 2 weeks for the first 6 months, then every month for 1 year, then every 3 months for 30 months | Recurrence or malignancy-free survival since immunotherapy start, for which the events of interest are the recurrence of OPL with LOH or malignant transformation of OPL |
| Primary | Change in LOH status (positive to negative) of OPL | 6 months | Change in LOH status (positive to negative) of OPL after 6 months since the start of immunotherapy. This is defined as disappearance of any high-risk LOH (and the nonappearance of any other high-risk LOH) in the site of the OPL at the histological sample after immunotherapy treatment |
| Secondary | Safety of immunotherapy in the treatment of OPL | Through study completion, an average of 5 years | Grade 3-5 adverse events or any treatment interruption due to toxicities (safety) |
| Secondary | Grading of OPL | 6 months | Change of histological grading of OPL |
| Secondary | Multi-omic signatures | 6 months and through study completion, an average of 5 years | Identification of multi-omic signatures associated with response to immunotherapy |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34001010 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04504552
GET https://conductscience.org/api/trials/v1/NCT04504552/registered