AMG 319 in HPV Positive and Negative HNSCC

Phase 2

Terminated

• Conditions: Human Papillomavirus (HPV); Positive or Negative Head and Neck Squamous Cell Carcinoma (HNSCC) of the Hypopharynx, Oropharynx, Oral Cavity, Supraglottis or Larynx
• Interventions: Drug: AMG 319 hydrate; Drug: Placebo

• Registration Number: NCT02540928
• Lead Sponsor: Cancer Research UK

Brief Summary

The purpose of this study is to determine whether a drug called AMG 319 has an effect on a patient's own immune response to head and neck cancer squamous cell carcinoma (HNSCC). This study is specifically for patients who are having surgery to treat their HNSCC

Detailed Description

Cancers use 'defence mechanisms' to hide from the immune system and teach the immune system not to destroy cancer cells. AMG 319 works by blocking these defence mechanisms in the tumour. It targets and blocks an important protein called PI3K delta.

In the laboratory this leads to removal of a group of inhibitory immune cells. Releasing the immune brakes leads to immune attack and destruction of cancer cells.

AMG 319 looks promising in laboratory studies and in a very early study in a small number of patients with leukaemia and we now wish to find out if it will be useful in treating patients with head and neck cancer.

This study is a randomised, doubleblind, placebo controlled Phase II trial looking at the effects of giving AMG 319 to patients with either human papilloma virus (HPV) positive or negative head and neck cancer squamous cell carcinoma (HNSCC). We propose to treat patients prior to resection surgery so that we can study the effect of AMG 319 on the cancer in fine detail.

Approximately 54 patients with HPV positive or negative HNSCC of the hypopharynx, oropharynx, oral cavity, supraglottis or larynx will be entered into the study. Patients will be randomly assigned to one of two treatment groups and will receive between 20 and 29 days of oral dosing with AMG 319 or placebo immediately before resection surgery.

Study Timeline

• Study First Submitted: 2015-08-25
• Study First Submitted QC: 2015-09-03
• Study First Posted: 2015-09-04
• Study Start: 2015-10
• Primary Completion: 2018-05-03
• Study Completion: 2018-05-03
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-16
• Last Update Posted: 2018-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 319 Hydrate	AMG 319 hydrate	Up to 36 patients will be randomised into the Active Treatment arm to receive AMG 319 400 mg once daily administered orally for a minimum of 20 days and a maximum of 29 days prior to resection surgery
Placebo	Placebo	Up to 18 patients will be randomised into the Placebo arm to receive Placebo once daily administered orally for a minimum of 20 days and a maximum of 29 days prior to resection surgery

Primary Outcome Measures

Name	Time	Method
Changes in CD8+ effector T cell numbers in tumour tissue	Screening and Surgery
Treatment emergent adverse events	Assessed until 60 days after a patients last dose

Secondary Outcome Measures

Name	Time	Method
Changes in tumour size	Screening and Pre-surgery
Steady State AMG 319 concentration in blood	Days 8, 15 pre dose & Day 22

Trial Locations

Locations (5)

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Queen Alexandra Hospital, Department of Oral and Maxillofacial Surgery; 🇬🇧 Portsmouth, United Kingdom

Churchill Hospital, Blenheim H&N Unit; 🇬🇧 Oxford, United Kingdom

Aintree University Hospital - Clatterbridge Cancer Centre; 🇬🇧 Liverpool, United Kingdom

Poole Hospital; 🇬🇧 Poole, United Kingdom