Study of Niraparib and Dostarlimab with Radiotherapy for Patients with Locally-Advanced Head and Neck Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer called locally advanced head and neck squamous cell carcinoma. The study will explore the effects of two medications, Niraparib and Dostarlimab, in combination with radiotherapy and chemotherapy. Niraparib is taken as a tablet, while Dostarlimab is given as an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to understand how effective these treatments are when used together. Participants will be divided into two groups. One group will receive both Niraparib and Dostarlimab along with radiotherapy and a chemotherapy drug called cisplatin. The other group will receive Niraparib and Dostarlimab with radiotherapy, but without cisplatin, as some patients may not be suitable for cisplatin treatment. The study will monitor the participants over time to see how well the cancer responds to the treatment and to check for any side effects.

The study will last several years, with regular check-ups and assessments to track the progress of the disease and the participants’ health. The main goal is to see if the combination of these treatments can help prevent the cancer from returning within a year. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

1 joining the study

Upon joining the study, the patient will be assigned to one of two groups based on their health condition and treatment suitability. The study involves patients with a specific type of head and neck cancer.

The patient will receive detailed information about the study and will be required to provide informed consent to participate.

2 initial treatment phase

The patient will begin the initial treatment phase, which includes the administration of two medications: dostarlimab and niraparib.

Dostarlimab is given as an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The dosage is 500 mg.

Niraparib is taken orally in the form of film-coated tablets, with a dosage of 100 mg per tablet.

3 radiotherapy

Following the initial treatment phase, the patient will undergo radiotherapy. This is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors.

The radiotherapy is combined with the medications to enhance the treatment’s effectiveness.

4 maintenance phase

After completing radiotherapy, the patient will enter the maintenance phase of the study.

During this phase, the patient will continue to receive niraparib and dostarlimab as part of their ongoing treatment plan.

5 follow-up and monitoring

Throughout the study, the patient’s health and response to treatment will be closely monitored through regular visits and tests.

The study aims to assess the effectiveness of the treatment in terms of disease-free survival over a period of one year.

Who Can Join the Study?

Sign a written and voluntary informed consent form.
Have proper organ function, which includes:
- Enough white blood cells, platelets, and hemoglobin (a protein in red blood cells).
- Normal levels of bilirubin (a substance made by the liver), AST, and ALT (liver enzymes).
- Albumin (a protein in the blood) levels of at least 3.0 g/dL.
For Cohort A:
- Creatinine clearance (a measure of kidney function) of at least 60 mL/min.
- No severe nerve damage (peripheral neuropathy) or significant hearing loss.
- Be between 18 and 70 years old (those over 70 may be eligible for Cohort B).
- No serious heart or blood vessel problems.
For Cohort B:
- Not suitable for cisplatin-based treatment due to:
  - Creatinine clearance between 30 and 60 mL/min.
  - Severe hearing loss or nerve damage.
  - Age over 70 years, but must pass a fitness test.
For women, proof of being post-menopausal or a negative pregnancy test is required.
Women who can have children must use effective birth control during and after treatment.
Men with partners who can have children must use a condom and spermicide during and after treatment.
Be willing and able to attend scheduled visits and follow the treatment plan.
Be 18 years or older, male or female.
Have a confirmed new diagnosis of a specific type of non-spreading squamous cell carcinoma.
If the cancer is related to human papillomavirus (HPV), it must be confirmed by specific tests.
Have positive PD-L1 expression, which is a specific protein found in some cancer cells.
Have a measurable tumor size as seen on a CT or MRI scan.
Provide a new biopsy sample of the tumor for analysis.
Have a good performance status, meaning you can carry out daily activities without much difficulty.

Who Cannot Join the Study?

Patients with a history of Carcinoma, which is a type of cancer, cannot participate.
Patients who are not within the specified age range for the study are excluded.
Patients who are not able to receive the specific treatments being tested in the study are excluded.
Patients who are part of a vulnerable population, meaning they may have additional health or social challenges, are excluded.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Ajuntament De L Hospitalet De Llobregat	L'hospitalet De Llobregat	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
Instituto de Investigacion Sanitaria Fundacion para la Investigacion del Hospital Clinico de Valencia-INCLIVA	Valencia	Spain
Heggftvf Uaesqzqwaklhr Hivqoixc Tdgbx y Ppnahy Idoexrrp Cwjbfb dtrrroyahdibgwbyy (hyua	Badalona	Spain
Hqtxgyjb Vhbx diufrnsm	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	08.11.2023

Trial locations

Investigated drugs:

Niraparib is a medication used in this trial to help treat patients with locally advanced head and neck squamous cell carcinoma. It is being tested for its effectiveness when given before and after radiotherapy. In some patients, it is also used during radiotherapy. Niraparib is being studied to see if it can improve the chances of the cancer not coming back after one year.

Dostarlimab is another medication involved in this trial. It is used in combination with niraparib to treat patients with the same type of cancer. Dostarlimab is given before and after radiotherapy to see if it can help improve treatment outcomes. The goal is to determine if this combination can prevent the cancer from returning within a year.

Cisplatin is a chemotherapy drug used in this trial for patients who can tolerate it. It is given alongside radiotherapy to help destroy cancer cells. The trial is investigating how well cisplatin works with the other medications to improve patient outcomes.

Radiotherapy is a treatment that uses high-energy rays to target and kill cancer cells. In this trial, it is used as a definitive treatment for patients with head and neck cancer. The study is examining how effective radiotherapy is when combined with the other medications in preventing cancer recurrence.

Investigated diseases:

Squamous cell carcinoma of head and neck

Carcinoma – Carcinoma is a type of cancer that begins in the skin or in tissues that line or cover internal organs. It is characterized by the uncontrolled growth of abnormal cells that can invade nearby tissues. Over time, these cancerous cells may spread to other parts of the body through the bloodstream or lymphatic system. Carcinomas are classified based on the type of epithelial cells they originate from, such as squamous cell carcinoma or adenocarcinoma. The progression of carcinoma can vary widely depending on the specific type and location of the cancer. Early stages may be asymptomatic, but as the disease advances, symptoms related to the affected organ or tissue may develop.

Trial ID:

2024-516779-33-00

Protocol code:

TTCC-2022-01-RADIAN

NCT ID:

NCT05784012

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Niraparib and Dostarlimab with Radiotherapy for Patients with Locally-Advanced Head and Neck Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?