Trial · NCT07539454
Nirogacestat in Patients With Kaposi Sarcoma
NCT07539454, Phase 2, Recruiting, AIDS Malignancy Consortium
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nirogacestat in Patients With Kaposi Sarcoma. Trials, record NCT07539454. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07539454
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nirogacestat in Patients With Kaposi Sarcoma
- NCT number
- NCT07539454
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 28 participants, estimated
- Lead sponsor
- AIDS Malignancy Consortium
- Conditions
- AIDS-Related Kaposi Sarcoma, Skin Kaposi Sarcoma
- Interventions
- Biospecimen Collection, Chest Radiography, Computed Tomography, Nirogacestat, Skin Biopsy
- First posted
- 2026-04-20
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) | Up to 5 years after completion of study treatment | The ORR will be estimated for each dose group and for all groups combined. The 95% confidence intervals will be constructed for the ORR. |
| Secondary | Incidence of adverse events (AEs) | Up to 5 years after completion of study treatment | The AEs will be tabulated by type, grade, and attribution. |
| Secondary | Duration of the response (DOR) | From the first date on which a partial response or complete response is documented until progression or death due to any cause, assessed up to 5 years after completion of study treatment | Non-responders will be excluded in DOR analysis. Participants who begin treatment but drop out prior to the first post-baseline response assessment will be considered non-responders. The Kaplan-Meier method will be used to describe the DOR for all treated participants. The proportional hazards model will be used to evaluate the association of HIV status and pretreatment status on the DOR. |
| Secondary | Cumulative proportion of study participants still in response | At 1 year | Will be estimated using the point estimate and the 95% confidence interval using Greenwood's formula for the standard error of the Kaplan-Meier estimate. |
| Secondary | Blood biomarkers | Up to 5 years after completion of study treatment | Will assess the effect of nirogacestat on blood biomarkers such as CD4+ and CD8+ T, CD19+, cell number, HIV and Kaposi sarcoma-associated herpesvirus virus load. The analysis of variance will be used to evaluate the changes from entry to 4 or 12 weeks in CD4 and CD8 cell counts and percentages and levels of plasma-associated HIV-1 ribonucleic acid (RNA). Descriptive statistics for biomarkers will be reported using mean, standard deviation, median, and range. Linear regression analysis and correlation coefficient analysis will be performed to examine the association between change from baseline in a specific biomarker and study covariates. |
| Secondary | Levels of Notch target and regulatory gene products | Baseline up to 5 years after completion of study treatment | Will assess baseline levels of Notch target and regulatory gene products as a target of Nirogacestat activity. Notch target and regulatory gene expression at baseline will be summarized using descriptive statistics, and data visualization will be performed using principal component analysis and T-distributed stochastic neighbor embedding (t-SNE) plots. Linear and generalized linear models will be used to examine the association between expression level and study covariates. When multiplicity adjustment is needed, Bonferroni correction and false discovery rate approaches will be considered. |
| Other | Tumor-associated Kaposi sarcoma-associated herpesvirus (KSHV) latent and lytic gene expression | Up to 5 years after completion of study treatment | Will assess the effect of Nirogacestat on tumor-associated KSHV latent and lytic gene expression. To evaluate the relationship between clinical response and quantitative measures of KSHV/human herpesvirus (HHV)-8 and HIV viral load, these measures will be tested to determine if they are normally distributed. If the data does not meet the assumptions of normality, the data will be transformed for analysis purposes. Analysis of variance will be used to assess the relationship between qualification of baseline levels of KSHV/HHV-8, HIV viral load, and response. Spearman rank correlation analysis will be used to evaluate the relationship between the qualification of baseline KSHV/HHV-8, HIV viral load and time to progression, and response duration. |
| Other | Activation of Notch target genes and Notch regulatory genes | Up to 5 years after completion of study treatment | Will assess effects of Nirogacestat on activation of Notch target genes and Notch regulatory genes. |
| Other | Tumor-associated endothelial-mesenchymal transition | At the end of Cycle 1 (each cycle is 28 days) | Will assess effects of Nirogacestat on tumor-associated endothelial-mesenchymal transition. Endothelial-mesenchymal transition will be assessed from scRNAseq. The following markers will be measured. Endothelial markers decreasing over time: CDH5 (VE-cadherin), PECAM1 (CD31), VWF (von Willebrand Factor), TEK (TIE2); Mesenchymal markers increasing over time: ACTA2 (a-SMA), VIM (vimentin), S100A4 (FSP-1), FN1 (Fibronectin); Master regulators of EMT increasing over time: SNAI1 (Snail), SNAI2 (Slug), TWIST1, ZEB1, ZEB2, LEF1. |
| Other | Peak plasma of Nirogacestat in KS patients | Cycle 1 pre-dose, 0.5, 1.5, and 3 hours post-first dose and Cycle 2 day 1, pre-dose (one cycle=28 days) | For pharmacokinetic analysis, 20 samples will be used (10 from responders and 10 from non-responders) to estimate peak plasma level. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UM1CA121947 | Consortium for Advancing Management and Prevention of Cancer in People with HIV | SPARANO, JOSEPH A. | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL CANCER INSTITUTE | 2015 to 2025 |
Source NIH RePORTER
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/NCT07539454
GET https://conductscience.org/api/trials/v1/NCT07539454/registered