Trial · NCT06528769
Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
NCT06528769, Phase 2, Recruiting, Gabriel Tinoco
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma. Trials, record NCT06528769. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06528769
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
- NCT number
- NCT06528769
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 16 participants, estimated
- Lead sponsor
- Gabriel Tinoco
- Conditions
- Leiomyosarcoma, Sarcoma
- Interventions
- all-trans retinoic acid, Cemiplimab, Computed Tomography, Magnetic resonance imaging, Biospecimen Collection
- First posted
- 2024-07-30
- Last updated
- 2026-10-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 24 months | Overall response rate (ORR) will be calculated based on modified RECIST version 1.1 and iRECIST with a 95% confidence interval (CI). |
| Secondary | Progression-free survival (PFS) | Up to 24 months | Progression free survival (PFS) will be defined as the time from initiation of therapy to the time of RECIST progression or death and will be calculated based on modified RECIST version 1.1 and iRECIST. Kaplan-Meier methods will be used to estimate PFS with 95% CI. |
| Secondary | Disease control rate (DCR) | Up to 24 months | Percentage of patients whose disease shrinks or remains stable. DCR will be calculated based on modified RECIST version 1.1 and iRECIST with a 95% confidence interval (CI). |
| Secondary | Overall survival (OS) | Up to 24 months | Overall survival (OS) will be defined as time from initiation of therapy to death, or censored at last follow-up date if the Patient is alive and will be calculated based on modified RECIST version 1.1 and iRECIST. Kaplan-Meier methods will be used to estimate OS with 95% CI. |
| Secondary | Dose limiting toxicity | From the first dose of study medication, up to 2 years | The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. |
| Secondary | Incidence of adverse events (AE) | From first dose of study medication, up to 2 years | As defined in Common Terminology Criteria for Adverse Events version 5. Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. |
| Other | Effect of ATRA on myeloid-derived suppressor cells (MDSCs) | Up to 24 months | MDSCs in peripheral blood from study patients will be summarized using mean +/- SEM, range, and median. Changes in these measurements from baseline to after treatment, or baseline to progression will be assessed using paired t-test or Wilcoxon signed rank test. |
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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06528769
GET https://conductscience.org/api/trials/v1/NCT06528769/registered