Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
NCT05172245 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46
Last updated 2026-05-18
Summary
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
- Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
- Head and Neck Carcinoma of Unknown Primary
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- Locally Advanced Hypopharyngeal Squamous Cell Carcinoma
- Locally Advanced Laryngeal Squamous Cell Carcinoma
- Locally Advanced Nasal Cavity Squamous Cell Carcinoma
- Locally Advanced Oral Cavity Squamous Cell Carcinoma
- Locally Advanced Oropharyngeal Squamous Cell Carcinoma
- Locally Advanced Paranasal Sinus Squamous Cell Carcinoma
- Locally Advanced Sinonasal Squamous Cell Carcinoma
- Maxillary Sinus Squamous Cell Carcinoma
- Stage III Hypopharyngeal Carcinoma AJCC v8
- Stage III Laryngeal Cancer AJCC v8
- Stage III Lip and Oral Cavity Cancer AJCC v8
- Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage III Sinonasal Cancer AJCC v8
- Stage IVA Hypopharyngeal Carcinoma AJCC v8
- Stage IVA Laryngeal Cancer AJCC v8
- Stage IVA Lip and Oral Cavity Cancer AJCC v8
- Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVA Sinonasal Cancer AJCC v8
- Stage IVB Hypopharyngeal Carcinoma AJCC v8
- Stage IVB Laryngeal Cancer AJCC v8
- Stage IVB Lip and Oral Cavity Cancer AJCC v8
- Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8
- Stage IVB Sinonasal Cancer AJCC v8
Interventions
- PROCEDURE
-
Biopsy Procedure
Undergo tumor biopsy
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- DRUG
-
Given IV
- PROCEDURE
-
Computed Tomography
Undergo CT or PET/CT
- DRUG
-
Ipatasertib
Given PO
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Positron Emission Tomography
Undergo PET/CT
- RADIATION
-
Radiation Therapy
Undergo radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
Malcolm D Mattes · University Health Network Princess Margaret Cancer Center LAO
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-19
- Primary Completion
- 2027-07-01
- Completion
- 2027-07-01
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
More Related Trials
-
Testing the Addition of M3814 (Peposertib) to Radiation Therapy for Patients With Advanced Head and Neck Cancer Who Cannot Take Cisplatin
NCT04533750 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer
NCT01810913 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
De-intensified Radiation Therapy With Chemotherapy (Cisplatin) or Immunotherapy (Nivolumab) in Treating Patients With Early-Stage, HPV-Positive, Non-Smoking Associated Oropharyngeal Cancer
NCT03952585 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Testing the Addition of an Anti-Cancer Drug, Camonsertib, to Radiation Therapy for Recurrent Head and Neck Squamous Cell Carcinoma
NCT07156227 ·Status: NOT_YET_RECRUITING ·Phase: PHASE1
-
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
NCT05063552 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
Cisplatin and Radiation Therapy Followed by Paclitaxel and Carboplatin in Treating Patients With Stage IB-IVA Cervical Cancer
NCT01295502 ·Status: UNKNOWN ·Phase: PHASE1
-
Cisplatin, Intensity-Modulated Radiation Therapy, and Pembrolizumab in Treating Patients With Stage III-IV Head and Neck Squamous Cell Carcinoma
NCT02775812 ·Status: COMPLETED ·Phase: PHASE1
-
Dose-escalating AZD1775 + Concurrent Radiation + Cisplatin for Intermediate/High Risk HNSCC
NCT02585973 ·Status: COMPLETED ·Phase: PHASE1
-
Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With Stage III or Stage IV Head and Neck Cancer
NCT00265941 ·Status: COMPLETED ·Phase: PHASE3
-
Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer
NCT00820248 ·Status: COMPLETED ·Phase: PHASE3
-
Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer
NCT00410826 ·Status: COMPLETED ·Phase: PHASE2
-
Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
NCT07195734 ·Status: RECRUITING ·Phase: PHASE2
-
Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer
NCT00544414 ·Status: COMPLETED ·Phase: PHASE2
-
S0216, Combination Chemotherapy and RT in Treating Patients With Stage III or Stage IV Head and Neck Cancer
NCT00054054 ·Status: COMPLETED ·Phase: PHASE2
-
Chemotherapy and Radiation Therapy With or Without Panitumumab in Treating Patients Who Have Undergone Surgery for Advanced Hypopharyngeal Cancer, Oropharyngeal Cancer, Laryngeal Cancer, or Oral Cavity Cancer at High Risk of Recurrence
NCT01142414 ·Status: WITHDRAWN ·Phase: PHASE3
-
Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Recurrent Head and Neck Cancer That Cannot Be Removed By Surgery
NCT00113399 ·Status: TERMINATED ·Phase: PHASE3
-
A Study of Xevinapant With Cisplatin and Radiation Therapy After Surgery in People With Head and Neck Cancer
NCT06145412 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
NCT01101451 ·Status: COMPLETED ·Phase: PHASE3
-
Combining Radiation Therapy With Immunotherapy for the Treatment of Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT05721755 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Ficlatuzumab, Cisplatin and IMRT in Locally Advanced Head and Neck Squamous Cell Carcinoma
NCT02277184 ·Status: TERMINATED ·Phase: PHASE1
-
Cetuximab, Carboplatin, and Paclitaxel Followed by Radiation Therapy, With or Without Cisplatin, in Treating Patients With Metastatic Head and Neck Cancer
NCT00301028 ·Status: COMPLETED ·Phase: PHASE2
-
Testing the Addition of an Investigational Drug, Xevinapant, to Usual Radiation Therapy Plus Cisplatin/Carboplatin for Patients With Head and Neck Cancer
NCT06084845 ·Status: WITHDRAWN ·Phase: PHASE2
-
Chemotherapy and Radiation Therapy Following Surgery in Treating Patients With Head and Neck Cancer
NCT00011999 ·Status: COMPLETED ·Phase: PHASE2
-
Cisplatin With or Without WEE1 Inhibitor MK-1775 in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
NCT02196168 ·Status: TERMINATED ·Phase: PHASE2
-
Onalespib in Treating Patients With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck Receiving Radiation Therapy and Cisplatin
NCT02381535 ·Status: COMPLETED ·Phase: PHASE1