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Monoclonal Antibodies

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

Phase 2
Recruiting
Research Sponsored by Ascendis Pharma Oncology Division A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

BelieveIT-201 Trial Summary

This trial will evaluate if two treatments and pembrolizumab can help people with head and neck cancer before surgery to reduce risk of recurrence and improve survival.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, immune-related issues due to activation of the body's defense system by the drugs being tested, fatigue, flu-like symptoms from IL-2 stimulation, and complications related to pembrolizumab.

BelieveIT-201 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major Pathological Response
Secondary outcome measures
Event Free Survival
Overall Survival
Pathological Complete Response
+1 more

BelieveIT-201 Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Ascendis Pharma Oncology Division A/SLead Sponsor
2 Previous Clinical Trials
613 Total Patients Enrolled
Joan MorrisStudy DirectorAscendis Pharma Oncology Division A/S
2 Previous Clinical Trials
280 Total Patients Enrolled
~51 spots leftby Apr 2025
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