Study of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and Pembrolizumab for Patients with Advanced Head and Neck Cancer

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What is this study about?

This clinical trial is focused on studying treatments for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC). The study will explore the effects of different treatment combinations, including TransCon TLR7/8 Agonist used with Pembrolizumab, TransCon TLR7/8 Agonist combined with TransCon IL-2 β/γ, and Pembrolizumab alone. Pembrolizumab is a medication that helps the immune system fight cancer cells, while TransCon TLR7/8 Agonist and TransCon IL-2 β/γ are investigational drugs being tested for their potential to enhance the immune response against cancer.

The purpose of this study is to evaluate how well these treatments work in reducing the size of the cancer before surgery. Participants will receive one of the treatment options, which may involve receiving the medication through an infusion into a vein or an injection directly into the tumor. The study will last for a period of up to 42 days, during which participants will be closely monitored by healthcare professionals. The goal is to determine which treatment is most effective in preparing the cancer for surgical removal.

Throughout the study, participants will undergo regular assessments to monitor their health and the response of the cancer to the treatment. These assessments will help researchers understand the potential benefits and any side effects of the treatments being tested. The information gathered from this trial will contribute to the development of more effective therapies for patients with LA-HNSCC.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and tumor characteristics.

Informed consent is required, ensuring understanding of the study’s requirements and restrictions.

2 treatment assignment

Participants are randomly assigned to one of three treatment groups: TransCon TLR7/8 Agonist with pembrolizumab, TransCon TLR7/8 Agonist with TransCon IL-2 β/γ, or pembrolizumab alone.

The purpose is to evaluate the effectiveness of these treatments as neoadjuvant therapy for head and neck cancer.

3 treatment administration

TransCon TLR7/8 Agonist is administered via intratumoral injection.

Pembrolizumab is given as an intravenous infusion, with a concentration of 25 mg/mL.

TransCon IL-2 β/γ is also administered through intravenous infusion.

The frequency and duration of these treatments are determined by the study protocol.

4 monitoring and assessments

Regular monitoring is conducted to assess the response to treatment and any side effects.

Assessments include imaging and biopsies to evaluate tumor response and progression.

5 surgery

Participants undergo surgery to remove the tumor, as planned based on the study protocol and local practice.

The effectiveness of the treatment is evaluated through pathological examination of the resected tumor.

6 follow-up

Post-surgery, participants are monitored for any recurrence of the disease and overall survival.

The study continues to track the incidence and severity of any adverse events.

Who Can Join the Study?

Participants must be at least 18 years old at the time of signing the consent form.
Must have at least one area that can be easily and safely accessed for an injection directly into the tumor.
For women who can have children: Must agree to avoid pregnancy by not having heterosexual intercourse or using very effective birth control methods, and must not donate eggs from the time of a negative pregnancy test before the study, during the study, and for 160 days after the last dose of the study drug.
For men with a female partner who can have children or is pregnant: Must agree to avoid pregnancy by not having heterosexual intercourse or using a double method of birth control (like a condom and spermicide), and must not donate sperm during the study and for 160 days after the last dose of the study drug.
Must be able to give signed consent, agreeing to follow the study’s requirements and restrictions.
Must have a new diagnosis of a type of head and neck cancer that can be surgically removed and has not spread to other parts of the body. This includes specific stages and types of tumors as defined by medical guidelines.
Must have a sample of the tumor available from a previous or new biopsy. A fine needle biopsy may be allowed after discussion with the study’s medical team.
Must be eligible and planning to have surgery for the head and neck cancer based on the doctor’s decision and local medical practices.
Must have results from testing the tumor for HPV (a virus) status using specific medical tests.
Must have adequate organ function, which includes specific levels of substances in the blood like bilirubin, liver enzymes, creatinine, blood cells, and thyroid hormones.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures the ability to perform daily activities.
In the opinion of the doctor, must be able to follow the treatment schedule and required assessments without delaying the planned surgery.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Hochschule Hannover	Hanover	Germany
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario Hm Sanchinarro	Madrid	Spain
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
University Hospital Jena KöR	Jena	Germany
University Medicine Greifswald	Greifswald	Germany
Hospital Clinico San Carlos	Madrid	Spain
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany
Universitaet Leipzig	Leipzig	Germany
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Orszagos Onkologiai Intezet	Budapest	Hungary
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Hospital Del Mar	Barcelona	Spain
Fundacion Instituto Valenciano De Oncologia	Valencia	Spain
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.	Siedlce	Poland
University Of Debrecen	Debrecen	Hungary
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital General Universitario De Valencia	Valencia	Spain
Zala Megyei Szent Rafael Korhaz	Zalaegerszeg	Hungary
Hospital Universitario Lucus Augusti	Lugo	Spain
Fundacio Assistencial De Mutua De Terrassa Fpc	Terrassa	Spain
Azienda Ospedaliero-Universitaria Maggiore Della Carita	Novara	Italy
University Of Pecs	Pecs	Hungary
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Ujsgaowpki Mhxjigw Coiuoo Hfjvcthoudnpsnayo	Hamburg	Germany
Izecfqxm Chaqtl Dcnabdveovqzohvth	L'hospitalet De Llobregat	Spain
Isxivzbo Rwiicgpgd Pmv Lg Sbkmjb Dun Tufvkb Drtd Awtormu Impi Szkwrn	Meldola	Italy
Anjqfas Orijtprcjuz Umkgrqxmcvlrh Sixmxh	Siena	Italy
Gpockhvsiuklgzkql Vsasdzhzl Ptty Aitsto Evimvuen Oaxhza Krxguq	Gyor	Hungary
Nqjakrkf Inmgzbdw Oaorrdsbs Iwt Mfzgo Sxxapapdolxpmuahkevwqmukrklb Igcirmps Bmjdyycu	Cracow	Poland
Hbkhhjfm Vjkd dljmnktq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	20.02.2024
Hungary	Not recruiting	20.02.2024
Italy	Not recruiting	20.02.2024
Poland	Not recruiting	20.02.2024
Spain	Not recruiting	20.02.2024

Trial locations

Investigated drugs:

TransCon TLR7/8 Agonist is a medication being studied for its potential to help the immune system fight cancer. It works by activating certain receptors in the body that can enhance the immune response against cancer cells. In this trial, it is being tested in combination with other treatments to see if it can improve outcomes for patients with head and neck cancer.

Pembrolizumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is already used in the treatment of various types of cancer, including head and neck cancer. In this trial, it is being used both alone and in combination with other medications to evaluate its effectiveness in treating advanced head and neck cancer.

TransCon IL-2 β/γ is an investigational therapy designed to stimulate the immune system by increasing the activity of certain immune cells. It is being tested in combination with the TransCon TLR7/8 Agonist to determine if this combination can enhance the body’s ability to fight cancer more effectively than other treatments.

Investigated diseases:

Squamous cell carcinoma of head and neck

Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC) – This is a type of cancer that occurs in the squamous cells lining the head and neck region. It is considered advanced when it has spread to nearby tissues or lymph nodes but is still potentially removable through surgery. The disease often begins with symptoms like a persistent sore throat, difficulty swallowing, or a lump in the neck. As it progresses, it may cause more severe symptoms, including changes in voice, unexplained weight loss, or persistent ear pain. The progression of this cancer can vary, with some cases remaining localized while others may spread to distant parts of the body.

Trial ID:

2023-506092-10-00

Protocol code:

ASND0038

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of TransCon TLR7/8 Agonist, TransCon IL-2 β/γ, and Pembrolizumab for Patients with Advanced Head and Neck Cancer

What is this study about?

Who Can Join the Study?

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