AIDS Malignancy Consortium
This phase II trial studies how well nirogacestat works in treating patients with skin Kaposi sarcoma (KS). Several anti-cancer drugs work well in treating KS, but there is no treatment that cures KS. Nirogacestat binds to a protein called gamma secretase, which blocks the activation of other proteins called Notch receptors. Blocking these proteins may help keep tumor cells from growing and may kill them. Nirogacestat is a type of gamma secretase inhibitor. Nirogacestat may be effective in shrinking the size of KS lesions and reducing the spread of lesions.
PRIMARY OBJECTIVE: I. Evaluate the efficacy of nirogacestat in terms of overall response (partial response \[PR\]) or complete response \[CR\]) of Kaposi sarcoma (KS) tumors. SECONDARY OBJECTIVES: I. Evaluate the safety and tolerability of nirogacestat. II. Evaluate the duration of response of KS tumors to nirogacestat. III. Assess the effect of nirogacestat on blood biomarkers such as CD4+ and CD8+ T, CD19+, cell number, human immunodeficiency virus (HIV) and Kaposi sarcoma-associated herpesvirus (KSHV) virus load. IV. Assess baseline levels of Notch target and regulatory gene products as…
Inclusion Criteria: * Biopsy-proven KS involving skin with or without visceral involvement either newly diagnosed or refractory to or intolerant of one or more prior therapies. * Patients must have cutaneous lesion(s) amenable to six total biopsies (minimum size of biopsy to be 4 mm), either six lesions \> 4 mm or one large lesion measuring 20 mm that can undergo serial biopsy, and at least five additional lesions measurable for assessment with no improvement over the past month. * Hemoglobin ≥ 8 g/dL (within three months prior to study entry) * Absolute neutrophil count (ANC) ≥ 1,000 cells/m…
Undergo collection of blood
Undergo chest X-ray
Undergo CT
Given PO
Undergo skin biopsy
Arctuva estimate
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