Actively Recruiting
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
46
Participants Needed
18
Research Sites
249 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 kill tumor cells and shrink tumors. Giving ipatasertib in combination with chemo-radiation may be better than chemo-radiation alone in treating patients with advanced head and neck cancer.
CONDITIONS
Official Title
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with pathologically confirmed locally advanced head and neck squamous cell carcinoma with measurable disease
- Oropharyngeal and unknown primary tumors must be tested for HPV; eligibility depends on HPV status and clinical stage
- Candidates for concurrent cisplatin chemotherapy and radiation therapy as determined by their doctor
- Able to swallow tablets at enrollment
- Age 18 years or older
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- Adequate blood counts and organ function including neutrophils, hemoglobin, platelets, albumin, bilirubin, liver enzymes, alkaline phosphatase, coagulation tests, creatinine clearance, and blood glucose
- HIV-infected patients on effective therapy with undetectable viral load
- Patients with past or resolved hepatitis B or C infection meeting specified viral load criteria
- Prior or concurrent malignancies allowed if not interfering with safety or efficacy
- Women of childbearing potential and men must agree to use effective contraception or abstinence during and 28 days after treatment
- Ability to understand and sign informed consent
- For dose expansion cohort, agreement to mandatory on-treatment biopsies when tumors allow
You will not qualify if you...
- Primary tumors of nasopharynx, salivary, thyroid, parathyroid glands, or skin
- Distant metastatic disease from current head and neck cancer
- Prior chemotherapy, radiation, or definitive surgery for current locally advanced cancer (except prior surgery for early stage with recurrence at least 3 months later)
- Recent chemotherapy or radiation within 6 weeks for prior malignancies; prior radiation must not overlap current treatment area
- Use of other investigational agents
- Allergic reactions to ipatasertib or similar compounds
- Treatment with strong CYP3A4 or P-glycoprotein inhibitors or inducers within 2 weeks before study drug
- Uncontrolled illnesses including active infection
- Pregnant or breastfeeding women
- Insulin-dependent diabetes
- History or active inflammatory bowel disease or active bowel inflammation
- Conditions interfering with swallowing or absorption of pills
- Lung diseases including pneumonitis, interstitial lung disease, cystic fibrosis, aspergillosis, active tuberculosis, or history of opportunistic infections
- Significant liver disease or active viral hepatitis
- Grade 2 or higher uncontrolled high cholesterol or triglycerides
AI-Screening
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Trial Site Locations
Total: 18 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
3
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
4
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
5
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
6
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
7
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
8
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
9
Rutgers New Jersey Medical School
Newark, New Jersey, United States, 07101
Actively Recruiting
10
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States, 10461
Actively Recruiting
11
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
12
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina, United States, 28203
Active, Not Recruiting
13
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, United States, 28025
Active, Not Recruiting
14
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
15
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
16
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Suspended
17
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
18
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Suspended
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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