TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma
Key facts
- Who runs it
- Ascendis Pharma A/S
- Where
- Boston, Canton, Charleston, Chicago, Cincinnati, Columbus, Detroit, Houston, Iowa City, Knoxville, Los Angeles, Louisville, New York, Rochester, San Francisco, and Springfield, United StatesSee the 16 sitesAlso in 7 other countries, 39 sites
- Trial code
- Status
- Terminated
- Phase
- Phase 2
- People taking part
- 27 people enrolled
- Started
- 29 Sept 2023
- Ended
- 28 Mar 2025
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- TransCon TLR7/8 Agonist
- Pembrolizumab
- TransCon IL-2 β/γ
- Record updated
- 1 August 2025
- Why it stopped
- The Sponsor made the decision to close enrollment as part of a strategic portfolio review.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Has local histologically confirmed new diagnosis of resectable, non-metastatic, SCC that is either: Stage III tumor HPV-positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M) 0; Stage III or IVA oropharyngeal tumor HPV-negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries regardless of HPV status (per American Joint Committee on Cancer [AJCC] Staging, 8th edition)
- Has available archived or fresh core or excisional biopsy of a tumor lesion. Note: Fine needle aspirations may be allowed after discussion with Medical Monitor
- Is eligible and plans for primary LA-HNSCC surgery based on investigator decision and per local practice
- Has results from tumor HPV status by p16 immunohistochemistry (IHC) for oropharyngeal tumors. (HPV DNA analysis for HPV tumor status is acceptable if that is the local standard of care analysis.)
- Has adequate organ function at screening
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Has at least one lesion that is deemed by the investigator to be easily and safely accessible for IT injection
Who cannot take part
- Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
- Active autoimmune conditions
- Has significant cardiac disease
- Has a known bleeding disorder that is deemed to place the participant at unacceptable risk for bleeding complications from IT injections or biopsies
Where in United States
Also in 7 other countries, 39 sites
- Boston, MassachusettsHospital not named in the registryNo longer taking part
- Canton, OhioHospital not named in the registryNo longer taking part
- Charleston, South CarolinaHospital not named in the registryNo longer taking part
- Chicago, IllinoisHospital not named in the registryNo longer taking part
- Cincinnati, OhioHospital not named in the registryNo longer taking part
- Columbus, OhioHospital not named in the registryNo longer taking part
- Detroit, MichiganHospital not named in the registryNo longer taking part
- Houston, TexasHospital not named in the registryNo longer taking part
- Iowa City, IowaHospital not named in the registryNo longer taking part
- Knoxville, TennesseeHospital not named in the registryNo longer taking part
- Los Angeles, CaliforniaHospital not named in the registryNo longer taking part
- Louisville, KentuckyHospital not named in the registryNo longer taking part
- New YorkHospital not named in the registryNo longer taking part
- Rochester, MinnesotaHospital not named in the registryNo longer taking part
- San Francisco, CaliforniaHospital not named in the registryNo longer taking part
- Springfield, IllinoisHospital not named in the registryNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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).
The 3 groups in the trial
- TransCon TLR7/8 Agonist in combination with pembrolizumabTreatment being tested
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
Treatment: TransCon TLR7/8 Agonist and Pembrolizumab
- TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γTreatment being tested
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
Treatment: TransCon TLR7/8 Agonist and TransCon IL-2 β/γ
- PembrolizumabExisting treatment, for comparison
Participants receive 2 cycles, once every 3 weeks of pembrolizumab alone as a 30-minute IV infusion
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- BelieveIT-201: Phase 2, Randomized Open-labeled Trial of TransCon (TC) TLR7/8 Agonist in Combination With Pembrolizumab or With TC IL-2 β/γ, or Pembrolizumab Alone as Neoadjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma
- Record updated
- 1 August 2025