Study of nivolumab treatment for patients with nasopharyngeal cancer who did not respond to or worsened after platinum chemotherapy

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What is this study about?

This clinical study focuses on patients with nasopharyngeal cancer, a type of cancer that develops in the nasopharynx – the upper part of the throat behind the nose. The study will evaluate the effectiveness of a medication called Nivolumab, which will be given to patients whose cancer has gotten worse during or after treatment with platinum-based chemotherapy.

The study will test how well Nivolumab works in treating this type of cancer. The medication is given as a solution through an intravenous infusion (directly into a vein). Each patient may receive treatment for up to 6 months, with regular doses of the medication.

During the study, patients will have their condition monitored through various medical examinations, including MRI scans (a type of detailed imaging that uses magnetic fields to create pictures of the inside of the body). The study will track how the cancer responds to the treatment, how long patients live without their disease getting worse, and what side effects may occur from the treatment.

1 Initial assessment

Your eligibility for the study will be confirmed based on your medical documentation showing nasopharyngeal cancer that has progressed during or after platinum-based chemotherapy

A medical evaluation will verify that you are over 18 years old and have an ECOG performance scale score of 0-1 (ability to perform daily activities)

2 Treatment initiation

You will receive Nivolumab (OPDIVO) through an intravenous infusion

The medication is given as a solution containing 10 mg/mL of the active substance

3 First evaluation period – 12 weeks

After 12 weeks of treatment, you will undergo an MRI scan to assess how your tumor is responding to the treatment

The medical team will measure if the tumor has decreased in size by at least 30% (partial response) or disappeared completely (complete response)

4 6-month assessment

At 6 months, you will have another MRI scan to check for any disease progression

Your overall health status will be evaluated

You will complete a quality of life questionnaire (EORTC QLQ-C30)

5 Long-term follow-up

Follow-up visits will continue for up to 18 months

Your overall survival and health status will be monitored at 12 months and 18 months

Additional quality of life assessments will be conducted

Regular safety evaluations will be performed throughout the study period

Who Can Join the Study?

You must be at least 18 years old
You must have a confirmed diagnosis of squamous cell carcinoma (a type of cancer that starts in the flat cells that line certain organs) through tissue or cell examination
Your cancer must have started in the nasopharynx (the upper part of the throat behind the nose)
You must have previously received platinum-based chemotherapy that either:
- Did not work effectively
- Your cancer got worse during treatment
Your cancer must have:
- Come back in the original location or lymph nodes, or
- Spread to other parts of the body during or within 6 months after platinum chemotherapy
Your ECOG performance status must be 0-1 (meaning you must be able to care for yourself and be up and about more than 50% of waking hours)
You must be willing and able to:
- Provide written informed consent
- Attend all follow-up visits
- Undergo all planned study procedures

Who Cannot Join the Study?

Age below 18 years old
Pregnant or breastfeeding women
Previous treatment with immunotherapy (medications that help your immune system fight cancer)
Active or untreated brain metastases (cancer that has spread to the brain)
Active autoimmune disease requiring systemic treatment (conditions where your immune system attacks your own body)
Uncontrolled or severe heart disease
Active hepatitis B or C infection (liver infections)
Active tuberculosis infection
HIV infection or AIDS
Other active cancers requiring treatment (except for certain skin cancers)
Major surgery within 4 weeks before starting the study
Treatment with other experimental drugs within 4 weeks before starting the study
Severe allergic reactions to similar medications in the past
Conditions that might interfere with study procedures or safety evaluations
Unable to give informed consent

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Bialostockie Centrum Onkologii Im. Marii Sklodowskiej-Curie W Bialymstoku	Bialystok	Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach	Kielce	Poland
Nszjvjaq Iyruksfn Odrpudyop Iai Mtfkg Ssygccvulnynlxpavikvlqfkhwpa Iluzxypc Bonypgki	Cracow	Poland
Uhlgmdzgdnfmch Cqfubed Kicshjqkm	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	27.08.2021

Trial locations

Investigated drugs:

Nivolumab

Nivolumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking cancer cells. By blocking this protein, Nivolumab allows your immune system to better recognize and destroy cancer cells. This medication is given through an intravenous infusion (through a vein).

Platinum-based chemotherapy refers to traditional cancer treatment medications that contain platinum. These medications work by damaging the DNA of cancer cells, which prevents them from dividing and growing. This is mentioned as a previous treatment that patients would have received before starting Nivolumab.

Investigated diseases:

Nasopharyngeal Cancer – A cancer that develops in the nasopharynx, which is the upper part of the throat behind the nose. The disease begins when healthy cells in the nasopharynx develop changes in their DNA, causing cells to grow uncontrollably and form a tumor. These abnormal cells can invade nearby structures and may spread to lymph nodes in the neck. The cancer can develop gradually, often starting with symptoms like a stuffy nose, sore throat, or problems with hearing. It tends to affect the area where the nasal passages connect with the throat, potentially impacting breathing and swallowing as it progresses.

Trial ID:

2024-517479-19-00

Protocol code:

20-NIO-0003

NCT ID:

NCT04875611

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of nivolumab treatment for patients with nasopharyngeal cancer who did not respond to or worsened after platinum chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?