NCT04555837

Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer

A Phase I-II, Open Label Study Evaluating the Safety and Efficacy of Alisertib and Pembrolizumab in Patients With Rb-Deficient Head and Neck Squamous Cell Carcinomas

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial investigates the best dose and effect of alisertib in combination with pembrolizumab in treating patients with Rb-deficient head and neck squamous cell cancer. Alisertib may help block the growth of cancer.. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving alisertib in combination with pembrolizumab may help control Rb-deficient head and neck squamous cell cancer. HPV positive head and neck cancers are Rb-deficient.

Detailed description

PRIMARY OBJECTIVES: I. To determine the recommend phase II dose of the combination of alisertib and pembrolizumab. (Phase I) II. To determine the overall response rate (ORR) and progression free survival (PFS) of patients with recurrent or metastatic Rb-deficient head and neck squamous cell carcinoma (HNSCC) treated with the combination of pembrolizumab and alisertib. (Phase II) SECONDARY OBJECTIVES: I. To evaluate the safety of the combination of pembrolizumab and alisertib in patients with solid tumors. II. To determine the overall survival in HNSCC patients treated with the combination of pembrolizumab and alisertib. III. To determine the relationship between pharmacokinetics, pharmacodynamics, baseline immune and tumor biomarkers and clinical responses in patients treated with alisertib and pembrolizumab. IV. To determine correlations between clinical responses and the effect of the treatment on human papilloma virus (HPV)-reactive T cells in HPV+ cancers. V. To determine correlations between clinical responses and tumor infiltrating lymphocyte function and T cell repertoire. OUTLINE: This is a phase I, dose-escalation study of alisertib in combination with fixed dose pembrolizumab followed by a phase II study. Patients receive alisertib orally (PO) twice daily (BID) on days 1-7 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-3 months.

Conditions

• Head and Neck Squamous Cell Carcinoma
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
DRUG	Alisertib	Given PO
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2020-09-15
• Primary completion: 2025-04-08
• Completion: 2025-04-08
• First posted: 2020-09-21
• Last updated: 2025-05-20
• Results posted: 2024-12-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study