NCT03113942

Study of Pomalidomide in Anal Cancer Precursors

Study of Pomalidomide in Anal Cancer Precursors (SPACE): a Phase 2 Study of Immunomodulation in People With Persistent HPV-associated High Grade Squamous Intraepithelial Lesions

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single centre open label phase II trial to determine the antitumor efficacy of the oral immunomodulatory agent pomalidomide in persistent human papillomavirus (HPV) -associated high grade squamous intra-epithelial lesions (HSIL) in patients with and without human immunodeficiency virus (HIV) infection.

Conditions

• High Grade Squamous Intra-epithelial Lesion (HSIL)

Interventions

Type	Name	Description
DRUG	Pomalidomide 2 MG Oral Capsule [Pomalyst]	Pomalidomide is an oral immunomodulatory derivative of thalidomide. Thalidomide and its derivatives are small molecules with broad effects on immune activation, including T-cell activation and responsiveness. Pomalidomide augments T cell responsiveness and proliferation by several mechanisms, many mediated by transcriptional regulation downstream of its primary target, cereblon. Effects include increased production of IL-2 and interferon-γ (IFN-γ), enhanced CD4+ and CD8+ T cell co-stimulation.

Timeline

• Start date: 2017-06-14
• Primary completion: 2019-03-31
• Completion: 2022-12-31
• First posted: 2017-04-14
• Last updated: 2022-03-31

Locations

1 site across 1 country: Australia