Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer

This phase I/Ib trial tests the safety and best dose of ipatasertib in combination with the usual treatment approach using chemotherapy together with radiation therapy ("chemo-radiation") in patients with head and neck cancer. 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. Cisplatin, which is a chemotherapy used in this trial, is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Radiation therapy uses high energy to ki

Trial Details

NCT ID
NCT05172245
Phase
PHASE1
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
HPV Positive Head and Neck Cancer
Interventions
  • Biopsy Procedure
  • Biospecimen Collection
  • Cisplatin
  • Computed Tomography
  • Ipatasertib
  • Magnetic Resonance Imaging
Locations (sample)
  • Tampa, Florida, United States|27.94752,-82.45843
  • Chicago, Illinois, United States|41.85003,-87.65005
  • Fairway, Kansas, United States|39.02223,-94.6319
  • Kansas City, Kansas, United States|39.11417,-94.62746
  • Westwood, Kansas, United States|39.04056,-94.6169

Key Eligibility Criteria

  • Patients must have pathologically confirmed HNSCC (including tumors of the oropharynx, hypopharynx, larynx, oral cavity, nasal cavity, maxillary an…
  • Oropharyngeal and unknown primary squamous cell cancers must test for human papilloma virus (HPV), for example by p16 immunohistochemistry (IHC), i…
  • Patients with p16-positive tumors are eligible if clinical stage III (cT4 or cN3, M0) according to the American Joint Committee on Cancer (AJCC)/TN…
  • Patients with p16-negative (or not tested) tumors are eligible if clinical stage III-IVB (locally advanced but non-metastatic) according to the AJC…

For full eligibility, visit ClinicalTrials.gov.

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