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NCT05172258 · ClinicalTrials.gov registry record · Phase 2

Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck

A Phase 2 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 2
Development phase
52
Enrollment target
20
Study locations

NCT05172258 is a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 52 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (56% lower). The trial reports 20 study locations across 7 states.

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The verdict

NCT05172258, a Phase 2 study of Head and Neck Squamous Cell Carcinoma and Metastatic Head-and-neck Squamous-cell Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
52 participants
Enrollment target
20
Study locations

Study Summary

This phase II trial compares the effect of adding ipatasertib to pembrolizumab (standard immunotherapy) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Ipatasertib is in a class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of tumor cells and may kill them. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ipatasertib in combination with pembrolizumab may be more effective than pembrolizumab alone in improving some outcomes in patients with recurrent/metastatic squamous cell cancer of the head and neck.

Conditions Studied

Head and Neck Squamous Cell Carcinoma Metastatic Head-and-neck Squamous-cell Carcinoma Recurrent Head and Neck Squamous Cell Carcinoma Recurrent Hypopharyngeal Squamous Cell Carcinoma Recurrent Laryngeal Squamous Cell Carcinoma Metastatic Hypopharyngeal Squamous Cell Carcinoma Metastatic Laryngeal Squamous Cell Carcinoma Recurrent Oral Cavity Squamous Cell Carcinoma Metastatic Oropharyngeal Squamous Cell Carcinoma Metastatic Oral Cavity Squamous Cell Carcinoma

Interventions

  • BIOLOGICAL Pembrolizumab
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Ipatasertib
  • PROCEDURE Biopsy Procedure

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • City of Hope at Irvine Lennar - Irvine
  • City of Hope Antelope Valley - Lancaster
  • Keck Medicine of USC Koreatown - Los Angeles
  • Los Angeles General Medical Center - Los Angeles
  • USC / Norris Comprehensive Cancer Center - Los Angeles
  • USC Norris Oncology/Hematology-Newport Beach - Newport Beach
  • Stanford Cancer Institute Palo Alto - Palo Alto
  • University of California Davis Comprehensive Cancer Center - Sacramento

New York

  • NYU Langone Hospital - Long Island - Mineola
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone - New York
  • NYP/Weill Cornell Medical Center - New York
  • Montefiore Medical Center-Einstein Campus - The Bronx
  • Montefiore Medical Center - Moses Campus - The Bronx

Wisconsin

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center - Madison
  • University of Wisconsin Carbone Cancer Center - University Hospital - Madison

District of Columbia

  • MedStar Georgetown University Hospital - Washington D.C.

Illinois

  • Northwestern University - Chicago

Kentucky

  • University of Kentucky/Markey Cancer Center - Lexington

Texas

  • University of Texas Medical Branch - Galveston

Trial Details

FieldValue
Enrollment Target 52 participants
Start Date 2022-07-26
Est. Completion 2027-06-30
Phase Phase 2

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT05172258

The ClinicalTrials.gov registry entry for NCT05172258 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (56% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.

NCT05172258 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, New York, Wisconsin.

Frequently Asked Questions

What is clinical trial NCT05172258 about?

NCT05172258 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck". This phase II trial compares the effect of adding ipatasertib to pembrolizumab (standard immunotherapy) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck that has come back (recurrent) or that has spread from where it first started (primary site) to other pl...

What is the current status of trial NCT05172258?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2022-07-26. Estimated completion is 2027-06-30.

What conditions does trial NCT05172258 study?

This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma.

What interventions are being tested in trial NCT05172258?

The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Ipatasertib (DRUG), Biopsy Procedure (PROCEDURE).

Who is sponsoring clinical trial NCT05172258?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05172258 being conducted?

This trial has 20 study locations across California, District of Columbia, Illinois, Kentucky, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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