Actively Recruiting
Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2025-04-24
32
Participants Needed
4
Research Sites
226 weeks
Total Duration
On this page
Sponsors
M
Maria Sklodowska-Curie National Research Institute of Oncology
Lead Sponsor
K
KCRI
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old
- Histological or cytological confirmation of squamous cell carcinoma
- Primary tumor located in the nasopharynx
- Disease progression during or after platinum-based chemotherapy
- Tumor recurrence or metastasis occurring during or within 6 months after platinum-based chemotherapy
- ECOG performance status of 0 or 1
- Willingness and ability to provide informed consent and comply with study visits and procedures
You will not qualify if you...
- Active central nervous system metastases
- Renal insufficiency with eGFR less than 30 ml/min/m2
- Liver dysfunction with AST or ALT over 2.5 times upper limit of normal (5 times if liver metastases), or total bilirubin over 1.5 times upper limit of normal unless fractionated with direct bilirubin under 35%, or albumin under 2.5 g/dL
- Blood abnormalities: hemoglobin under 9 g/dL, platelets under 100 x 10^9/L, or absolute neutrophil count under 1.0 x 10^9/L
- Ejection fraction under 50% on echocardiography
- History of active autoimmune diseases except type I diabetes, treated hypothyroidism, psoriasis, or albinism
- Diagnosed mental disorders preventing trial participation
- Pregnancy or breastfeeding
- Unwillingness or inability to use contraception during and for 5 months after trial
- Prior treatment with anti-PD-1/L1/L2 or anti-ICOS agents
- Current participation in another clinical trial
- Active infections affecting clinical condition
- Prior bone marrow or solid organ transplantation
- Need for immunosuppressive agents including daily prednisone over 10 mg
- Known immunodeficiency including HIV/AIDS
- Receipt of live vaccine within 28 days before enrollment
- Heart failure classified as NYHA III or IV
- Active or recent malignant tumors with less than 2 years disease-free period, except certain treated cancers
- Other medical conditions judged by investigator to prevent participation
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku
Bialystok, Poland
Actively Recruiting
2
Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego
Gdansk, Poland
Actively Recruiting
3
Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
Gliwice, Poland, 44-101
Actively Recruiting
4
Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii
Kielce, Poland
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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