Nivolumab treatment for nasopharyngeal cancer after platinum therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy of Nivolumab, an immunotherapy drug, in patients with nasopharyngeal cancer who have experienced disease progression during or after platinum-based chemotherapy. It is a multicenter, non-randomized, prospective trial aiming to enroll 32 patients who are not candidates for radical therapy. Participants must have documented squamous cell carcinoma of the nasopharynx and meet specific inclusion criteria related to their treatment history and overall health status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \> 18 years old
2. Histological or cytological documentation of squamous cell carcinoma.
3. Primary tumor location in nasopharynx
4. Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy
5. Tumor recurrence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy
6. ECOG(Eastern Cooperative Oncology Group) performance scale 0-1
7. Participant is willing and able to give informed consent for participation in the study and agrees to undergo all follow up visit and planned procedures.

Exclusion Criteria:

1. Known active central nervous system metastases.
2. Presence of renal insufficiency defined as eGFR(estimated glomerular filtration rate) \< 30 ml/min/m2
3. Presence of liver disfunction, defined as level of AST(aspartate aminotransferase) and /or ALT(alanine aminotransferase) \> 2,5 x ULN(upper limits of normal) (\> 5 x ULN in patients with documented liver metastases); total bilirubin \> 1,5 xULN ( bilirubin \> 1,5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \< 35%) or albumin \< 2,5 g/dL
4. Abnormalities in blood count such as: hemoglobin \< 9 g/dl, platelets \< 100 x 109 /L, Absolute Neutrophil Count (ANC) \<1,0 x 109 /L
5. Ejection fraction in echocardiography \< 50%
6. History of active autoimmune diseases except for type I diabetes, hypothyroidism (treated only with hormone supplementation), psoriasis, albinism.
7. Patient with diagnosed mental disorder preventing, in Investigator's opinion, from participating in a clinical trial.
8. Pregnancy or breastfeeding.
9. Female with childbearing potential or male participant with female partner of childbearing potential, who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period and for 5 months after the end of treatment (last infusion)
10. Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
11. Patient is currently participating in another clinical trial.
12. Active infection, which significantly affects the patient's clinical condition and requires treatment.
13. Patient with prior bone marrow or solid organ transplantation.
14. Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent \> 10 mg)
15. Known immunodeficiency including HIV/AIDS(human immunodeficiency virus/acquired immunodeficiency syndrome) infection.
16. Patient received any live vaccine within 28 days before enrollment.
17. Heart Failure - NYHA(New York Heart Association functional classification system) III or IV
18. Coexistence of active malignant tumor or history of malignant tumor after radical treatment with disease-free period \> 2 years, except: cervical cancer in situ/ basocellular skin cancer/prostate cancer, after radical treatment.
19. Other comorbidities symptoms or conditions that in Investigator's judgement prevent patient from participation in clinical trial.

Where it's running

• Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku
  Bialystok, Poland Recruiting
• Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego
  Gdansk, Poland Recruiting
• Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
  Gliwice, Poland Recruiting
• Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii
  Kielce, Poland Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.