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

NCT04169074 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-05-22

Study results available
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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).

Conditions

  • HNSCC

Interventions

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.

Sponsors & Collaborators

  • George Washington University

    collaborator OTHER

  • University of Arizona

    lead OTHER

Principal Investigators

  • Ricklie Julian, MD · University of Arizona

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-07
Primary Completion
2024-12-16
Completion
2025-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169074 on ClinicalTrials.gov