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 (Sep 2026). This Phase 1 trial studies multiple treatments including Cisplatin and Ipatasertib for clinical stage ii 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
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage CN3, CT2-3N2, IMAGING-DETECTED EXTRANODAL EXTENSION (IENE), III, IVB (other)
Oropharyngeal and unknown primary squamous cell cancers must test for human papilloma virus (HPV)... Patients with p16-positive tumors are eligible if M0 and any of one the following: cT4 or cN3 or cT2-3N2 or imaging-detected extranodal extension (iENE)... Patients with p16-negative (or not tested) tumors are eligible if clinical stage III-IVB (locally advanced but non-metastatic)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy for current locally advanced HNSCC
Prior treatment (e.g., chemotherapy, radiation, or definitive surgery) for the current locally advanced HNSCC is not permitted
Cannot have received: radiation therapy for current locally advanced HNSCC
Prior treatment (e.g., chemotherapy, radiation, or definitive surgery) for the current locally advanced HNSCC is not permitted
Cannot have received: definitive surgery for current locally advanced HNSCC
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 to head and neck or adjacent anatomical site for another malignancy with overlap to current area
Among patients who received prior radiation to the head and neck or adjacent anatomical site for another malignancy, there may be no overlap with current area to be irradiated
Lab requirements
Blood counts
Absolute neutrophil count >= 3000/mcL; Hemoglobin >= 10 g/dL; Platelets >= 150,000/mcL; Serum albumin >= 3 g/dL
Kidney function
Creatinine clearance > 60 mL/min (Cockroft-Gault formula)
Liver function
Total bilirubin <= 1.5 x ULN; AST/ALT <= 2.5 x ULN / 2 x ULN; ALP <= 2.0 x ULN
Absolute neutrophil count >= 3000/mcL; Hemoglobin >= 10 g/dL; Platelets >= 150,000/mcL; Serum albumin >= 3 g/dL; Total bilirubin <= 1.5 x ULN; AST/ALT <= 2.5 x ULN / 2 x ULN; ALP <= 2.0 x ULN; Creatinine clearance > 60 mL/min (Cockroft-Gault formula)
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 →Frequently asked questions
Is NCT05172245 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy for current locally advanced HNSCC, radiation therapy for current locally advanced HNSCC, definitive surgery for current locally advanced HNSCC disqualifies patients from enrollment.
What disease stage is eligible?
Stage CN3 or CT2-3N2 or IMAGING-DETECTED EXTRANODAL EXTENSION (IENE) or III or IVB is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages