Testing the Addition of an Anti-cancer Drug, Ipatasertib, to the Usual Immunotherapy Treatment (Pembrolizumab) in Patients With Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (NCT05172258)
A Phase 2 Study of Ipatasertib in Combination With Pembrolizumab for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck
🩺 Plain-English Summary (8th-Grade Level)
This phase II trial compares the effect of adding ipatasertib to pembrolizumab (standard immunotherapy) vs. pembrolizumab alone in treating patients with squamous cell cancer of the head and neck that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving ipatasertib in combination with pembrolizumab may be more effective than pembrolizumab alone in improving some outcomes in patients with recurrent/metastatic squamous cell cancer of the head and neck.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (26 items) and avoid the listed exclusions (22 items).
Location: City of Hope Comprehensive Cancer Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Prior treatment with a checkpoint inhibitor given for relapsed or metastatic disease. Prior treatment with a checkpoint inhibitor for locally advanced disease as part multidisciplinary treatment is allowed.
- History of malabsorption syndrome or other condition that would interfere with enteral absorption or result in the inability or unwillingness to swallow pills.
- Patient has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the study principal investigator (PI).
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine or physiologic corticosteroid replacement for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Type 1 or Type 2 diabetes mellitus requiring insulin at study entry are ineligible.
- Patients who are on a stable dose of oral diabetes medication \>= 4 weeks prior to initiation of study treatment may be eligible for enrollment. Patients must meet the laboratory eligibility criteria for fasting blood glucose and hemoglobin A1c.
- Fasting glucose =\< 150 mg/dL (8.3 mmol/L) and hemoglobin A1c =\< 7.5% (58 mmol/mol).
- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1). Note: Patients with grade =\< 2 neuropathy or grade =\< 2 alopecia are an exception to this criterion and may qualify for the study. Note: If patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Patients who are receiving any other investigational agents.
- Patients with known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (20 Sites)
- City of Hope Comprehensive Cancer Center — Duarte, California
- City of Hope at Irvine Lennar — Irvine, California
- City of Hope Antelope Valley — Lancaster, California
- Keck Medicine of USC Koreatown — Los Angeles, California
- Los Angeles General Medical Center — Los Angeles, California
- USC / Norris Comprehensive Cancer Center — Los Angeles, California
- USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California
- Stanford Cancer Institute Palo Alto — Palo Alto, California
- University of California Davis Comprehensive Cancer Center — Sacramento, California
- MedStar Georgetown University Hospital — Washington D.C., District of Columbia
- Northwestern University — Chicago, Illinois
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- NYU Langone Hospital - Long Island — Mineola, New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York
- NYP/Weill Cornell Medical Center — New York, New York
- Montefiore Medical Center-Einstein Campus — The Bronx, New York
- Montefiore Medical Center - Moses Campus — The Bronx, New York
- University of Texas Medical Branch — Galveston, Texas
- University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin
- University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Head and Neck Squamous Cell Carcinoma
- 3-5 FrAction Stereotactic Body Radiation Therapy for Palliation of Head and Neck Squamous Cell Carcinoma: the FAST Phase II Randomized Trial — Houston, Texas
- Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III-IVA Squamous Cell Carcinoma of the Head and Neck Who Have Undergone Surgery — Birmingham, Alabama
- Study of Zanzalintinib (XL092) + Pembrolizumab vs Pembrolizumab in Subjects With PD-L1 Positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma — Fullerton, California
- A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2) — Mobile, Alabama
- Preoperative Pembrolizumab and Chemotherapy in Resectable, Recurrent HNSCC — Boston, Massachusetts
- Ficerafusp Alfa, Pembrolizumab, and Stereotactic Body Radiotherapy (SBRT) for Head and Neck Squamous Cell Carcinoma (HNSCC) — St Louis, Missouri
Explore by condition: All Head and Neck Squamous Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.