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Abemaciclib and Pembrolizumab in Metastatic or Recurrent Head and Neck Cancer

NCT03938337 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-07-09

Study results available
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Summary

To assess the objective response rate of tumor lesions to abemaciclib in combination with pembrolizumab in patients with metastatic or recurrent squamous cell carcinoma of head and neck.

Conditions

Interventions

DRUG

Cohort 1 Not Previously Treated

Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks

DRUG

Cohort 2 Treated Previously

Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Eddy Yang, MD · University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-08
Primary Completion
2020-04-03
Completion
2020-04-03
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT03938337 on ClinicalTrials.gov