Study on TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and Pembrolizumab Before Surgery for Advanced Head and Neck Cancer

Sponsor: Ascendis Pharma A/S

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05980598

Provider View

This clinical trial is testing the safety and effectiveness of a combination of new drugs, TransCon TLR7/8 Agonist and TransCon IL-2 β/γ, with pembrolizumab, given before surgery to treat advanced head and neck cancer. After surgery, participants will receive standard care and be monitored for up to two years.

Patient Parameters

Program Overview

The aim of this study is to see if using TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab before surgery can help treat advanced head and neck squamous cell carcinoma (HNSCC). The trial will first test the safety of two treatment combinations: one with TransCon TLR7/8 Agonist and pembrolizumab, and another with TransCon TLR7/8 Agonist and TransCon IL-2 β/γ. After this, the study will compare these combinations to pembrolizumab alone to see which is more effective and safe.

Description

This study involves three different treatment groups for patients with advanced head and neck cancer that can be surgically removed. The trial begins with a safety phase involving 12 participants, split into two groups to test the safety of the drug combinations. After this phase, 80 more participants will be randomly assigned to one of three groups: one receiving TransCon TLR7/8 Agonist with pembrolizumab, another receiving TransCon TLR7/8 Agonist with TransCon IL-2 β/γ, and the last group receiving only pembrolizumab. Participants will start treatment within five days of being assigned to a group and will receive the study drugs every 21 days for two cycles before undergoing surgery. After surgery, they may receive additional standard treatments as decided by their doctor.

Eligibility Criteria

Inclusion Criteria

  • Have a new diagnosis of resectable, non-metastatic squamous cell carcinoma (SCC) in the head and neck area, at specific stages and types.
  • Have a tumor sample available for testing.
  • Be eligible and planning for surgery to remove the cancer.
  • Have results showing the HPV status of the tumor if it is in the oropharynx.
  • Have good organ function and be in good general health (ECOG status 0 or 1).
  • Have at least one tumor that can be safely accessed for injection.

Exclusion Criteria

  • Have active autoimmune diseases.
  • Have significant heart disease.
  • Have a bleeding disorder that increases the risk of complications from injections or biopsies.
  • Have an immune deficiency or are taking high doses of steroids or other immune-suppressing treatments.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.