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TransCon (TC) TLR7/8 Agonist, TC IL-2 β/γ, Pembrolizumab Prior to Surgery for Advanced Head and Neck Squamous Cell Carcinoma

NCT ID: NCT05980598

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2025-03-28

Brief Summary

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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).

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Detailed Description

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This is a randomized, Phase 2, open-label, multicenter trial of TransCon TLR7/8 Agonist in combination with pembrolizumab, TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ, or pembrolizumab monotherapy as neoadjuvant therapy in participants with Stage III-IVA resectable LA-HNSCC.

This trial starts with a safety run-in of 12 participants, 6 participants each in Arms A (TransCon TLR7/8 Agonist plus pembrolizumab) and B (TransCon TLR7/8 Agonist plus TransCon IL-2 β/γ) randomized 1:1.

After completing the safety run-in, 80 participants will be randomized in a 2:2:1 ratio in 3 treatment Arms A, B or C (pembrolizumab monotherapy).

Once randomized, participants should begin treatment within 5 calendar days. Participants enrolled after the safety run-in, into the 2:2:1 randomization part of the trial, will be stratified as follows: oropharyngeal HPV p16 positive versus oropharyngeal HPV p16 negative or larynx/hypopharyngeal/oral cavity regardless of HPV p16 status. All participants should receive study drug(s) every 21 days (Q21D) for 2 cycles followed by curative-intent surgery. After surgery, participants may receive standard-of-care treatment in the adjuvant setting, as per investigator's decision and local guidelines.

Conditions

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Head and Neck Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TransCon TLR7/8 Agonist in combination with pembrolizumab

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 Type EXPERIMENTAL

TransCon TLR7/8 Agonist

Intervention Type DRUG

TLR7/8 agonist prodrug

Pembrolizumab

Intervention Type DRUG

A type of immunotherapy that works by blocking the PD-1 pathway to help prevent cancer cells from hiding

TransCon TLR7/8 Agonist in combination with TransCon IL-2 β/γ

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 Type EXPERIMENTAL

TransCon TLR7/8 Agonist

Intervention Type DRUG

TLR7/8 agonist prodrug

TransCon IL-2 β/γ

Intervention Type DRUG

Sustained systemic release of IL-2 β/γ with selective receptor binding that may stimulate the immune system to kill cancer cells

Pembrolizumab

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

Group Type ACTIVE_COMPARATOR

Pembrolizumab

Intervention Type DRUG

A type of immunotherapy that works by blocking the PD-1 pathway to help prevent cancer cells from hiding

Interventions

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TransCon TLR7/8 Agonist

TLR7/8 agonist prodrug

Intervention Type DRUG

Pembrolizumab

A type of immunotherapy that works by blocking the PD-1 pathway to help prevent cancer cells from hiding

Intervention Type DRUG

TransCon IL-2 β/γ

Sustained systemic release of IL-2 β/γ with selective receptor binding that may stimulate the immune system to kill cancer cells

Intervention Type DRUG

Other Intervention Names

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Keytruda™

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascendis Pharma A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan Morris

Role: STUDY_DIRECTOR

Ascendis Pharma Oncology Division A/S

Locations

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Ascendis Investigational Site

Los Angeles, California, United States

Site Status

Ascendis Investigational Site

San Francisco, California, United States

Site Status

Ascendis Investigational Site

Chicago, Illinois, United States

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Ascendis Investigational Site

Springfield, Illinois, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Ascendis Investigational Site

Boston, Massachusetts, United States

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Ascendis Investigational Site

Detroit, Michigan, United States

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Ascendis Investigational Site

Rochester, Minnesota, United States

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New York, New York, United States

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Ascendis Pharma Investigational Site

Canton, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Ascendis Investigational Site

Houston, Texas, United States

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Kutaisi, Imereti, Georgia

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Ascendis Investigational Site

Tbilisi, , Georgia

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Ascendis Investigational Site

Tbilisi, , Georgia

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Ascendis Investigational Site II

Tbilisi, , Georgia

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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Erlangen, Bavaria, Germany

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Greifswald, , Germany

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Jena, , Germany

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Leipzig, , Germany

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Mannheim, , Germany

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Ulm, , Germany

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Pécs, Baranya, Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Győr, , Hungary

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Zalaegerszeg, , Hungary

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Meldola, , Italy

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Milan, , Italy

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Milan, , Italy

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Modena, , Italy

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Naples, , Italy

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Novara, , Italy

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Pavia, , Italy

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Rozzano, , Italy

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Gliwice, , Poland

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Siedlce, , Poland

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Warsaw, , Poland

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Barcelona, , Spain

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Barcelona, , Spain

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El Palmar, , Spain

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Ascendis Investigational Site

L'Hospitalet de Llobregat, , Spain

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Ascendis Investigational Site

Lugo, , Spain

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Ascendis Investigational Site

Madrid, , Spain

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Ascendis Investigational Site II

Madrid, , Spain

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Ascendis Investigational Site

Madrid, , Spain

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Ascendis Investigational Site

Madrid, , Spain

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Ascendis Investigational Site

Málaga, , Spain

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Ascendis Investigational Site

Pamplona, , Spain

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Ascendis Investigational Site

Terrassa, , Spain

Site Status

Ascendis Investigational Site

Valencia, , Spain

Site Status

Ascendis Investigational Site

Valencia, , Spain

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Ascendis Investigational Site

Valencia, , Spain

Site Status

Ascendis Investigational Site

Zaragoza, , Spain

Site Status

Ascendis Investigational Site

Kaohsiung City, , Taiwan

Site Status

Ascendis Investigational Site

Kaohsiung City, , Taiwan

Site Status

Ascendis Investigational Site

Taichung, , Taiwan

Site Status

Ascendis Investigational Site

Tainan City, , Taiwan

Site Status

Ascendis Investigational Site

Taoyuan District, , Taiwan

Site Status

Countries

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United States Georgia Germany Hungary Italy Poland Spain Taiwan

Other Identifiers

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ASND0038

Identifier Type: -

Identifier Source: org_study_id

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