Study of Domvanalimab and Zimberelimab Combined with Chemotherapy for Previously Untreated Recurrent or Metastatic Head and Neck Cancer

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What is this study about?

This study focuses on Head and Neck Squamous Cell Carcinoma that has returned after previous treatment or spread to other parts of the body. The study will test new combination treatments using four medications: domvanalimab, zimberelimab, paclitaxel, and carboplatin. These medications are given through an intravenous infusion, which means they are delivered directly into a vein.

The purpose of this research is to evaluate how well the combination of domvanalimab and zimberelimab with chemotherapy works compared to zimberelimab with chemotherapy alone in treating this type of cancer. Both domvanalimab and zimberelimab are types of immunotherapy medications that help the body’s immune system fight cancer cells, while paclitaxel and carboplatin are traditional chemotherapy drugs that directly attack cancer cells.

During the study, participants will receive their assigned treatment combination through regular infusion sessions. The treatments will continue for up to two years, depending on how well they work and how well they are tolerated. Throughout the study, doctors will monitor participants’ health and regularly check how their cancer responds to the treatment using various medical tests and examinations.

1 Initial assessment

Your eligibility for the study will be confirmed based on your medical condition – recurrent or metastatic head and neck squamous cell carcinoma

A tissue sample from your tumor will be required for testing. This can be from previous samples taken within the last 24 months, or a new sample may need to be collected

If you have cancer of the oropharynx, your HPV status will need to be confirmed through testing

2 Treatment assignment

You will be randomly assigned to receive one of two treatment combinations:

Option 1: Domvanalimab and zimberelimab with chemotherapy

Option 2: Zimberelimab with chemotherapy

The chemotherapy includes paclitaxel and carboplatin

3 Treatment administration

All medications will be given through intravenous infusion (directly into your vein)

Treatment will continue for up to 24 months

Regular assessments will be performed to monitor your response to treatment

4 Monitoring period

Your tumor response will be measured using imaging scans

Blood tests will be performed to check your laboratory values

Any side effects will be monitored and recorded

The total monitoring period will last up to 36 months

5 Follow-up period

After completing treatment, you will be monitored for an additional 100 days

During this time, any ongoing side effects will continue to be tracked

Final assessments will be performed to evaluate your overall response to the treatment

Who Can Join the Study?

Must be 18 years or older and able to understand and provide written informed consent
Must have confirmed squamous cell carcinoma (a type of cancer) of the:
– oral cavity (mouth)
– oropharynx (throat)
– hypopharynx (lower part of throat)
– larynx (voice box)
that cannot be cured by local treatments
Must not have received any previous systemic therapy (treatment that affects the whole body) for recurrent or metastatic head and neck cancer. Patients who had disease progression more than 6 months after completing platinum-based therapy for locally advanced disease may participate
Must have at least one measurable tumor that can be seen on CT scan or MRI according to specific measurement criteria (RECIST v1.1)
Must have adequate tumor tissue samples available for testing. These can be:
– Previously collected tissue samples from within the past 24 months
– New tissue samples if older samples are not available
For patients with oropharyngeal cancer (throat cancer), must have known HPV status (a test that shows if human papillomavirus is present in the tumor). If test results are not available, a tumor sample must be provided for testing before starting the study

Who Cannot Join the Study?

Prior therapy with an anti-PD-1 or anti-PD-L1 antibody (medications that affect immune system response)
Active or untreated brain metastases (cancer that has spread to the brain)
History of autoimmune disease requiring systemic treatment (conditions where immune system attacks healthy cells)
Active or chronic viral hepatitis or HIV infection
Uncontrolled high blood pressure or heart disease
Major surgery within 28 days before starting the study treatment
Previous or current pneumonitis (inflammation of lung tissue) requiring steroid treatment
Active infection requiring systemic therapy
Other malignancies (cancers) within 2 years prior to study entry, except for successfully treated non-melanoma skin cancer
Pregnant or breastfeeding women
Known allergies to study medications or their components
Participation in another clinical trial within 28 days before starting this study
Psychiatric conditions that could interfere with study compliance
Life expectancy less than 3 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
IRCCS Humanitas Research Hospital	Rozzano	Italy
Hospital Clinico San Carlos	Madrid	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Istituto Oncologico Veneto	Padua	Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Hospital Universitario 12 De Octubre	Madrid	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Crcfke Lgnb Bwhhdh	Lyon	France
Hxuiqasw Vojj djcwpbxe	Barcelona	Spain
Iofskhwa Curmi	Paris	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	03.03.2025
Italy	Not recruiting	03.03.2025
Spain	Not recruiting	03.03.2025

Trial locations

Investigated drugs:

Domvanalimab is a type of immunotherapy medication that works by helping your immune system fight cancer cells. It belongs to a class of drugs that target specific proteins to enhance the body’s natural defense against cancer, particularly in head and neck cancer.

Zimberelimab is also an immunotherapy medication that helps activate your immune system to fight cancer cells. It works by blocking certain proteins that can prevent your immune system from attacking cancer cells effectively.

Chemotherapy is a traditional cancer treatment that uses powerful medications to kill cancer cells or stop them from growing. In this trial, it is used in combination with the immunotherapy medications to potentially improve treatment outcomes for head and neck cancer.

Head and Neck Squamous Cell Carcinoma (HNSCC) – A cancer that begins in the squamous cells that line the moist surfaces inside the head and neck regions. These cancers commonly start in the mouth, nose, throat, or voice box. When described as recurrent, it means the cancer has returned after initial treatment. Metastatic HNSCC indicates that the cancer has spread from its original location to other parts of the body. The disease typically develops gradually, starting as pre-cancerous changes in the squamous cells. As it progresses, it can affect nearby tissues and structures, potentially impacting basic functions like breathing, swallowing, and speaking.

Trial ID:

2024-513121-22-00

Protocol code:

GS-US-699-7184-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Domvanalimab and Zimberelimab Combined with Chemotherapy for Previously Untreated Recurrent or Metastatic Head and Neck Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?