RecruitingPhase 2NCT04875611

Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment

Phase II Study Evaluating the Efficacy of Nivolumab in the Treatment of Patients With Nasopharyngeal Cancer Who Progressed During or After Platinum-based Chemotherapy


Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Enrollment

32 participants

Start Date

Aug 26, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Multicentre , non-randomized, prospective clinical trial to assess efficacy of Nivolumab in treatment of nasopharyngeal cancer who progressed during or after platinum-based chemotherapy . Patients disqualified from radical therapy . The total number of patients was estimated for 32.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests nivolumab, an immunotherapy drug, in patients with nasopharyngeal cancer (a cancer of the upper part of the throat, behind the nose) that has progressed during or after platinum-based chemotherapy. Nivolumab works by removing the "brakes" on the immune system, allowing it to attack cancer cells. **You may be eligible if...** - You are over 18 with confirmed squamous cell carcinoma of the nasopharynx - Your cancer has come back or spread during or within 6 months after platinum-based chemotherapy - Your overall health score is acceptable (ECOG 0–1) - Your kidney, liver, and blood function meet minimum requirements **You may NOT be eligible if...** - You have active cancer spread to the brain - You have significant kidney problems (low filtration rate) - You have significant liver dysfunction or low blood counts (anemia, low platelets, or low neutrophils) - Your heart's pumping function is less than 50% on an echocardiogram - You have an active autoimmune disease (exceptions: treated thyroid disease or type 1 diabetes) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOpdivo

Dose of Nivolumab is constant and is 240 mg .All patients will undergo maximum of 12 cycles of investigation product's infusion ( around 6 month of treatment).Each cycle will be done in intervals of 14 day (no less than 12 days after previous infusion and no longer than 42 day/6 weeks after previous infusion).


Locations(4)

Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku

Bialystok, Poland

Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego

Gdansk, Poland

Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach

Gliwice, Poland

Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii

Kielce, Poland

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NCT04875611


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