NCT04169074

Immune Modulation by Abemaciclib in Head and Neck Squamous Cell Carcinoma (HNSCC). (AIM Trial)

Immune Modulation by Abemaciclib in HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC): A Phase II Window Trial.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a Phase II single-arm window trial to assess the clinical and biological effects of neoadjuvant abemaciclib in patients with HPV-negative head and neck squamous cell carcinoma (HNSCC).

Detailed description

This is a Phase II single-arm window trial to assess the clinical and biological effects of 10-21 days of neoadjuvant abemaciclib in patients with HPV-negative HNSCC who are planned for oncologic surgery, with pre-clinically informed genetic and immune biomarker correlatives. In the window-of-opportunity clinical trial, patients planned for oncologic surgery are briefly exposed to a novel cancer agent in the window between diagnostic biopsy and definitive surgery. Paired, pre- and post-surgical tumor specimens permit ex vivo analysis of target modulation in both tumor and the tumor microenvironment - providing insight into mechanism of action and paving the way for rigorous companion biomarker development. Clinical activity is assessed by quantitative change in tumor size (∆T), which is correlated to hypothesis-driven genomic and immune biomarkers of interest. Investigators hypothesize that abemaciclib will significantly reduce tumor burden as measured by ∆T. Further, investigators will test the primary biomarker hypothesis that the clinical activity of abemaciclib is associated with an increased proportion of tumors that are T-cell inflamed. Investigators will evaluate tumor-intrinsic, tumor microenvironment (TME), and microbiome biomarker hypotheses in specific genetic contexts, including tumors with specific classes of tumor protein 53 (TP53) mutations, p16 loss, and/or CCND1 amplification.

Conditions

• HNSCC

Interventions

Type	Name	Description
DRUG	Abemaciclib	Treatment will consist of a single neoadjuvant cycle of 10-21 days (+7 days). Abemaciclib will be administered from days 1-21. Abemaciclib may be continued for an additional 7 days, or up to 28 days, for delays in planned surgery.

Timeline

• Start date: 2021-06-16
• Primary completion: 2024-12-16
• Completion: 2025-01-13
• First posted: 2019-11-19
• Last updated: 2026-01-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study