Study of TG4001 and Avelumab for Patients with Advanced HPV-16 Positive Cancers

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What is this study about?

This clinical trial is focused on studying certain types of cancers that are linked to a virus called Human Papillomavirus (HPV), specifically the type known as HPV-16. The cancers being studied include those that can occur in areas such as the head and neck, cervix, vulva, vagina, penis, and anus. The study is testing a combination of two treatments: avelumab, which is a type of cancer immunotherapy, and TG4001, which is another form of immunotherapy designed to help the body’s immune system fight cancer cells.

The purpose of the study is to evaluate how safe and effective these treatments are when used together in patients with advanced stages of these HPV-16 related cancers. The study will be conducted in two phases. In the first phase, the focus will be on understanding the safety and how well patients tolerate the combination of avelumab and TG4001. In the second phase, the study will look at how well the combination works in terms of slowing down the progression of the cancer compared to using avelumab alone.

Participants in the study will receive the treatments through injections or infusions, and their health will be monitored over time to see how the cancer responds to the treatment. The study aims to provide valuable information on whether this combination of treatments can offer a new option for patients with these types of cancers.

1 initial treatment phase

The trial begins with the administration of two medications: avelumab and tipapkinogene sovacivec (TG4001).

Avelumab is given as an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The dosage is 20 mg/mL.

Tipapkinogene sovacivec (TG4001) is administered as a subcutaneous injection, which means it is injected under the skin.

2 phase Ib evaluation

The primary goal during this phase is to assess the safety and tolerability of the combination of TG4001 and avelumab.

Patients with recurrent or metastatic HPV-16 positive advanced malignancies are monitored for any adverse effects.

3 phase II part 1 evaluation

The focus shifts to evaluating the efficacy of the combination treatment in terms of the overall response rate.

This is measured using a standard called RECIST 1.1, which helps in assessing how well the cancer responds to the treatment.

4 phase II part 2 evaluation

The objective is to compare the progression-free survival of patients receiving the combination of TG4001 and avelumab versus those receiving avelumab alone.

Progression-free survival refers to the length of time during and after treatment that a patient lives with the disease without it getting worse.

5 ongoing monitoring

Throughout the trial, patients undergo regular assessments to monitor their overall health and the effectiveness of the treatment.

This includes measuring the size of tumors using imaging techniques like CT scans, according to RECIST 1.1 criteria.

6 trial completion

The trial is expected to conclude by December 31, 2026.

Final results will be analyzed to determine the overall success and safety of the treatment combination.

Who Can Join the Study?

Patients must be female or male and at least 18 years old, with no upper age limit.
Women who can have children must have a negative blood pregnancy test at the start of the study.
Both male and female patients must use highly effective birth control if there is a chance of pregnancy during the study and for 3 months after the last treatment.
Patients must have an ECOG PS of 0 or 1, which means they should be fully active or have some symptoms but can still do light work.
Patients should have a life expectancy of at least 3 months.
For Phase Ib and Phase II part 1, patients must have certain types of cancer that are positive for HPV-16 and have spread or returned after treatment. For Phase II part 2, patients must have HPV-16 positive cancers like cervical, vulvar, vaginal, penile, and anal cancer.
The disease must not be treatable with surgery or radiotherapy that can cure it, and there must be proof that the disease is getting worse.
For Phase Ib and Phase II part 1, patients may have had up to 2 previous treatments with chemotherapy for cancer that has spread or returned. For certain head and neck cancers, patients must have had platinum-based therapy before. For Phase II part 2, patients can have had no more than one previous treatment for cancer that has spread or returned. Some patients may not need prior treatment if they meet specific conditions.
For patients with cancer that has spread to the liver, there should be no more than 3 liver lesions, and the largest one should be 30 mm or smaller.
Patients must have at least one lesion that can be measured by a CT scan.
Patients must have adequate blood, liver, and kidney function.

Who Cannot Join the Study?

Patients who have liver metastases at the start of the study. Liver metastases means that cancer has spread to the liver from another part of the body.
Patients who are not positive for HPV-16. HPV-16 is a type of virus that can cause certain cancers.
Patients who do not have recurrent or metastatic cancer. Recurrent means the cancer has come back after treatment, and metastatic means the cancer has spread to other parts of the body.
Patients who are not diagnosed with the specific types of cancer being studied, such as oropharyngeal squamous cell carcinoma, cervical cancer, vulvar cancer, vaginal cancer, penile cancer, or anal cancer.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Colmar	Colmar	France
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Virgen De Las Nieves	Granada	Spain
Institut De Cancerologie Strasbourg Europe	STRASBOURG, Alsace	France
Hospital General Universitario De Valencia	Valencia	Spain
Institut de Cancérologie de l’Ouest	Saint-Herblain	France
Hospital Universitario Virgen De La Victoria	Malaga	Spain
Crxkhl Lusb Brngdf	Lyon	France
Anwemiarpl Pkganeil Hktgrbpy Dg Mivqifeph	Marseille	France
Bmipcetx Ufbxdxyqzk Hjiqmjpv Cieikh	Besançon	France
Hpjkaair Uwamiacbovesd Hgzdlcla Tckoe y Pixkhw Iyykrbep Ciwflh dszsxstyvhpjbdtmh (gylk	Badalona	Spain
Ikefzqoh Cdtdv	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.09.2017
Spain	Not recruiting	01.09.2017

Trial locations

Investigated drugs:

Avelumab

TG4001 is a therapeutic vaccine designed to help the immune system recognize and fight against HPV-16 positive cancer cells. It works by stimulating the body’s immune response to target and destroy these cancer cells, potentially slowing down or stopping the progression of the disease.

Avelumab is an immunotherapy medication that helps the immune system attack cancer cells. It is a type of drug known as a checkpoint inhibitor, which works by blocking a protein that prevents the immune system from effectively attacking cancer cells. This can help the body to better recognize and destroy cancer cells.

Investigated diseases:

Oropharyngeal Squamous Cell Carcinoma of Head and Neck – This is a type of cancer that occurs in the oropharynx, which is the middle part of the throat. It often begins in the squamous cells lining the oropharynx. The disease can progress by spreading to nearby tissues and lymph nodes. It is associated with HPV-16, a type of human papillomavirus. As it advances, it may cause symptoms like a sore throat, difficulty swallowing, and changes in voice.

Cervical Cancer – This cancer starts in the cervix, the lower part of the uterus that connects to the vagina. It is often linked to HPV-16 infection. The disease progresses from pre-cancerous changes in the cervix to invasive cancer. Symptoms may include abnormal vaginal bleeding, pelvic pain, or pain during intercourse. It can spread to nearby tissues and organs if not detected early.

Vulvar Cancer – Vulvar cancer begins in the vulva, the external part of the female genitalia. It is often associated with HPV-16 infection. The disease may start as a precancerous condition called vulvar intraepithelial neoplasia. As it progresses, it can invade deeper tissues and spread to nearby lymph nodes. Symptoms might include itching, pain, or a lump in the vulvar area.

Vaginal Cancer – This rare cancer starts in the vagina, the muscular tube connecting the external genitals to the uterus. It is sometimes linked to HPV-16 infection. The disease can progress from pre-cancerous changes to invasive cancer. Symptoms may include abnormal vaginal bleeding, discharge, or a mass in the vagina. It can spread to nearby tissues and lymph nodes.

Penile Cancer – Penile cancer begins in the tissues of the penis, often in the skin cells. It is associated with HPV-16 infection. The disease may start as a small lesion or sore on the penis. As it progresses, it can invade deeper tissues and spread to lymph nodes. Symptoms might include changes in skin color, a growth or sore on the penis, or swelling.

Anal Cancer – Anal cancer starts in the anus, the opening at the end of the digestive tract. It is often linked to HPV-16 infection. The disease progresses from pre-cancerous changes to invasive cancer. Symptoms may include anal bleeding, pain, or a lump near the anus. It can spread to nearby tissues and lymph nodes if not treated.

Trial ID:

2024-515119-23-00

Protocol code:

TG4001.12

NCT ID:

NCT03260023

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of TG4001 and Avelumab for Patients with Advanced HPV-16 Positive Cancers

What is this study about?

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