Immunotherapy + Pembrolizumab for Head and Neck Cancer
(BelieveIT-201 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this trial is to evaluate the safety and efficacy of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and pembrolizumab given prior to curative intent surgery in treatment of participants with newly diagnosed Stage III/IVA resectable locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC). After surgery, participants will receive local standard-of-care treatment and will be followed for safety, efficacy, and survival for up to 2 years.This trial contains a safety run-in to evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ). The safety run-in will be followed by the randomized Phase 2, open-label part of the trial comparing the safety, efficacy and survival of treatment Arm A or Arm B compared to treatment Arm C (pembrolizumab monotherapy).
Who Is on the Research Team?
Joan Morris
Principal Investigator
Ascendis Pharma Oncology Division A/S
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed, resectable Stage III/IVA head and neck squamous cell carcinoma. Participants must have a tumor suitable for surgery, adequate organ function, an ECOG performance status of 0 or 1, and no immunodeficiency or significant cardiac disease. They should not be on high-dose steroids or other immune-suppressing drugs.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Safety Run-in
Evaluate the safety and tolerability of the two treatment arms: Arm A (TransCon TLR7/8 Agonist plus pembrolizumab) and Arm B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ)
Treatment
Participants receive study drug(s) every 21 days for 2 cycles followed by curative-intent surgery
Follow-up
Participants are monitored for safety, efficacy, and survival after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
- TransCon IL-2 β/γ
- TransCon TLR7/8 Agonist
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascendis Pharma A/S
Lead Sponsor
Ascendis Pharma Oncology Division A/S
Lead Sponsor