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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

4 criteria

  • 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**.
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Investigated drugs

  • 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.

What is already known about the treatment

  • TG4001

    TG4001 is administered as an injection and is currently being studied in clinical trials for its potential use in treating HPV-16 positive recurrent or metastatic cancers, such as cervical and head and neck cancers. It is in the investigational stage, with ongoing research to determine its effectiveness and safety. The main therapeutic indication is for HPV-16 positive malignancies. TG4001 works by stimulating the immune system to recognize and attack cancer cells associated with the HPV-16 virus. It is classified as a therapeutic cancer vaccine.

  • Avelumab

    Avelumab is administered through intravenous infusion and is an approved medication used in the treatment of various cancers, including Merkel cell carcinoma and urothelial carcinoma. In the context of the clinical trial, it is being evaluated in combination with TG4001 for HPV-16 positive cancers. Avelumab is a monoclonal antibody that works by blocking the PD-L1 protein, helping the immune system to detect and destroy cancer cells. It belongs to the class of immune checkpoint inhibitors.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-515119-23-00Protocol codeTG4001.12Estimated enrolment142 patientsSponsorTransgene

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