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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
NCT05172258 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2022-07-26 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05172258
The ClinicalTrials.gov registry entry for NCT05172258 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05172258 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, New York, Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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, Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Squamous Cell Carcinoma, Recurrent Hypopharyngeal Squamous Cell Carcinoma, Recurrent Laryngeal Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05172258?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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