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

Clinical Trial Details

This study is being done to evaluate if adding the drug ipatasertib to the usual approach is able to safely lower the chance of head and neck squamous cell cancer growing or spreading. This study aims to determine if this approach is better or worse than the usual approach.

The usual approach consists of treatment with immunotherapy using pembrolizumab. Pembrolizumab is approved by the U.S. Food and Drug Administration (FDA) and is administered through a vein in the arm.

Ipatasertib is considered investigational, which means it has not yet been approved by the FDA. Ipatasertib is taken orally in pill form.

Participants will be randomized into 1 of 2 study groups. Randomization is like flipping a coin and there is a 50/50 chance of being assigned to either group.

Group 1 will receive pembrolizumab plus Ipatasertib in 21-day cycles. The study team will discuss the dosing schedule with each participant in this group.

Group 2 will receive pembrolizumab alone in 21-day cycles at doses determined by the study team.

Participation will last until the disease gets worse or side effects become too severe for a maximum of 24 months.

Key Eligibility:

Patients must have a confirmed recurrent or metastatic head and neck squamous cell cancer (HNSCC) that is considered incurable.
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension with CT scan, MRI, or calipers by clinical exam.
Primary tumor locations of oral cavity, oropharynx, hypopharynx, and larynx are allowed. Participants may not have a primary tumor site of nasopharynx.
Patients should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy which was given as part of multimodal treatment for locally advanced disease is allowed.

Detailed eligibility will be discussed when reaching out to the study team.

Return to List

Study contact by location

Upper East Side - Manhattan

Contact(s)

June Greenberg, RN
(212) 746-2651
jdg2002@med.cornell.edu

Primary Investigator(s)

Doru Paul, MD, PhD

Protocol ID(s)

Weill Cornell Medicine IRB #:

2304025959

ClinicalTrials.gov:

NCT05172258

Status

Open to Enrollment

Age Group

Adult

Disease

Head and Neck Cancer