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

Official Summary

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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 52 participants

Interventions

• PROCEDURE: Biopsy Procedure — Undergo biopsy
• PROCEDURE: Biospecimen Collection — Undergo collection of blood samples
• PROCEDURE: Computed Tomography — Undergo CT
• DRUG: Ipatasertib — Given PO
• BIOLOGICAL: Pembrolizumab — Given IV

Primary Outcomes

• Progression free survival (PFS) (From date of randomization until disease progression, death, or date of last contact, whichever occurs first, assessed up to 1 year after the last patient is enrolled)

Secondary Outcomes

• Incidence of adverse events (Up to 1 year after the last patient is enrolled)
• Overall response rate (Up to 1 year after the last patient is enrolled)
• Duration of response (From the date of the scan that first documented a PR or CR until the patient demonstrates a PFS event, assessed up to 1 year after the last patient is enrolled)
• Changes in the tumor microenvironment by immunophenotyping (Baseline up to 1 year after the last patient is enrolled)
• Changes in Akt, ERK, and MEK signaling (Baseline up to 1 year after the last patient is enrolled)

Trial Locations

• City of Hope Comprehensive Cancer Center, Duarte, California, United States
• City of Hope at Irvine Lennar, Irvine, California, United States
• City of Hope Antelope Valley, Lancaster, California, United States
• Keck Medicine of USC Koreatown, Los Angeles, California, United States
• Los Angeles General Medical Center, Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
• USC Norris Oncology/Hematology-Newport Beach, Newport Beach, California, United States
• Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
• University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
• MedStar Georgetown University Hospital, Washington D.C., District of Columbia, United States
• ...and 10 more locations

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