CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Alisertib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04555837
NCT04555837Phase 2Completed

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

M.D. Anderson Cancer Center·interventional·Posted Sep 21, 2020·Updated May 20, 2025

In Brief

A Phase 2 clinical trial evaluating Alisertib and Pembrolizumab for Head and Neck Squamous Cell Carcinoma and Malignant Solid Neoplasm. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedSep 21, 2020
Enrollment StartSep 15, 2020
Primary CompletionApr 8, 2025
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 5.8 years ago

Interventions

Alisertibdrug

Given PO

Pembrolizumabbiological

Given IV