Immunotherapy + Pembrolizumab for Head and Neck Cancer
(BelieveIT-201 Trial)

Recruiting in Palo Alto (17 mi)

+54 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ascendis Pharma A/S

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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).

Eligibility Criteria

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

My cancer is a new, operable, non-spreading squamous cell carcinoma.

My organs are working well.

I am scheduled for surgery on my head or neck cancer.

+4 more

Exclusion Criteria

Active autoimmune conditions

I have a serious heart condition.

Known bleeding disorder that poses unacceptable risk for bleeding complications from IT injections or biopsies

+1 more

Participant Groups

The trial tests the safety and effectiveness of two experimental treatments (TransCon TLR7/8 Agonist with pembrolizumab in Arm A; TransCon TLR7/8 Agonist with TransCon IL-2 β/γ in Arm B) against pembrolizumab alone (Arm C). It includes a safety run-in phase followed by randomized comparison over up to two years post-surgery.

3Treatment groups

Experimental Treatment

Active Control

Group I: TransCon TLR7/8 Agonist in combination with pembrolizumabExperimental Treatment2 Interventions

Participants receive 2 cycles, once every 3 weeks of TransCon TLR7/8 Agonist intratumoral (IT) injection in combination with pembrolizumab as a 30-minute intravenous (IV) infusion

Group II: TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γExperimental Treatment2 Interventions

Participants receive 2 cycles, once every 3 weeks of TransCon TLR7/8 Agonist (IT injection) in combination with TransCon IL-2 β/γ as a 30-minute IV infusion

Group III: PembrolizumabActive Control1 Intervention

Participants receive 2 cycles, once every 3 weeks of pembrolizumab alone as a 30-minute IV infusion

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: