findmyKOL
Clinical trialNCT05172258Active, not recruitingPhase 2Interventional

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

SponsorNational Cancer Institute (NCI)Enrollment52Head and Neck Squamous Cell CarcinomaMetastatic Head and Neck Squamous Cell CarcinomaMetastatic Hypopharyngeal Squamous Cell CarcinomaMetastatic Laryngeal Squamous Cell CarcinomaMetastatic Oral Cavity Squamous Cell CarcinomaMetastatic Oropharyngeal Squamous Cell Carcinoma+9 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

20 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • City of Hope Comprehensive Cancer Center

    Duarte, California, United States

  • City of Hope at Irvine Lennar

    Irvine, California, United States

  • City of Hope Antelope Valley

    Lancaster, California, United States

  • Keck Medicine of Usc Koreatown

    Los Angeles, California, United States

  • Los Angeles General Medical Center

    Los Angeles, California, United States

  • Usc / Norris Comprehensive Cancer Center

    Los Angeles, California, United States

  • Usc Norris Oncology/hematology-Newport Beach

    Newport Beach, California, United States

  • Stanford Cancer Institute Palo Alto

    Palo Alto, California, United States

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, United States

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, United States

  • Northwestern University

    Chicago, Illinois, United States

  • University of Kentucky/markey Cancer Center

    Lexington, Kentucky, United States

  • Nyu Langone Hospital - Long Island

    Mineola, New York, United States

  • Laura and Isaac Perlmutter Cancer Center at Nyu Langone

    New York, New York, United States

  • Nyp/weill Cornell Medical Center

    New York, New York, United States

  • Montefiore Medical Center - Moses Campus

    The Bronx, New York, United States

  • Montefiore Medical Center-Einstein Campus

    The Bronx, New York, United States

  • University of Texas Medical Branch

    Galveston, Texas, United States

  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

    Madison, Wisconsin, United States

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
26 Jul 2022
Primary completion
30 Jun 2027
Completion
30 Jun 2027
Last update posted
13 May 2026
Registered enrollment
52
Registry id
NCT05172258

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.