OncoMatch/Clinical Trials/NCT05172245
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
Is NCT05172245 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cisplatin and Ipatasertib for clinical stage iii hpv-mediated (p16-positive) oropharyngeal carcinoma ajcc v8.
Treatment: Cisplatin · Ipatasertib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: CDKN2A p16 overexpression (positive)
Oropharyngeal and unknown primary squamous cell cancers must test for human papilloma virus (HPV), for example by p16 immunohistochemistry (IHC), in situ hybridization (ISH), or polymerase chain reaction (PCR). Patients with p16-positive tumors are eligible if clinical stage III (cT4 or cN3, M0)...
Required: CDKN2A p16-negative (negative)
Patients with p16-negative (or not tested) tumors are eligible if clinical stage III-IVB (locally advanced but non-metastatic)...
Disease stage
Required: Stage III, IVA, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: Patients who underwent prior definitive surgery alone for an early stage (T1-2N0) HNSCC which has now recurred with stage III-IVB disease at least 3 months after the initial surgery are eligible
Prior treatment (e.g., chemotherapy, radiation, or definitive surgery) for the current locally advanced HNSCC is not permitted
Cannot have received: radiation therapy
Exception: Patients who underwent prior definitive surgery alone for an early stage (T1-2N0) HNSCC which has now recurred with stage III-IVB disease at least 3 months after the initial surgery are eligible
Prior treatment (e.g., chemotherapy, radiation, or definitive surgery) for the current locally advanced HNSCC is not permitted
Cannot have received: definitive surgery
Exception: Biopsies, including those performed under anesthesia, are not considered surgery. Patients who underwent prior definitive surgery alone for an early stage (T1-2N0) HNSCC which has now recurred with stage III-IVB disease at least 3 months after the initial surgery are eligible
Prior treatment (e.g., chemotherapy, radiation, or definitive surgery) for the current locally advanced HNSCC is not permitted
Lab requirements
Blood counts
Absolute neutrophil count >= 3000/mcL; Hemoglobin >= 10 g/dL; Platelets >= 150,000/mcL; Serum albumin >= 3 g/dL; PTT (or aPTT) and INR <= 1.5 institutional ULN (except for patients receiving anticoagulation therapy)
Kidney function
Creatinine clearance (CLcr) > 60 mL/min (Cockroft-Gault formula)
Liver function
Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 2.5 x institutional ULN / 2 x institutional ULN; ALP <= 2.0 x institutional ULN
Absolute neutrophil count >= 3000/mcL; Hemoglobin >= 10 g/dL; Platelets >= 150,000/mcL; Serum albumin >= 3 g/dL; Total bilirubin <= 1.5 x institutional ULN; AST/ALT <= 2.5 x institutional ULN / 2 x institutional ULN; ALP <= 2.0 x institutional ULN; PTT (or aPTT) and INR <= 1.5 institutional ULN (except for patients receiving anticoagulation therapy); Creatinine clearance (CLcr) > 60 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Moffitt Cancer Center · Tampa, Florida
- Northwestern University · Chicago, Illinois
- University of Kansas Clinical Research Center · Fairway, Kansas
- University of Kansas Cancer Center · Kansas City, Kansas
- University of Kansas Hospital-Westwood Cancer Center · Westwood, Kansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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