Status:
RECRUITING
Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborating Sponsors:
KCRI
Conditions:
Nasopharyngeal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 dis...
Eligibility Criteria
Inclusion
- Age \> 18 years old
- Histological or cytological documentation of squamous cell carcinoma.
- Primary tumor location in nasopharynx
- Previous, documented failure on platinum-based chemotherapy or progression of the disease during platinum-based chemotherapy
- Tumor recurrence (local or nodal) or generalization (metastasis) occurence during or within 6 months after previous platinum-based chemotherapy
- ECOG(Eastern Cooperative Oncology Group) performance scale 0-1
- 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
- Known active central nervous system metastases.
- Presence of renal insufficiency defined as eGFR(estimated glomerular filtration rate) \< 30 ml/min/m2
- 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
- Abnormalities in blood count such as: hemoglobin \< 9 g/dl, platelets \< 100 x 109 /L, Absolute Neutrophil Count (ANC) \<1,0 x 109 /L
- Ejection fraction in echocardiography \< 50%
- History of active autoimmune diseases except for type I diabetes, hypothyroidism (treated only with hormone supplementation), psoriasis, albinism.
- Patient with diagnosed mental disorder preventing, in Investigator's opinion, from participating in a clinical trial.
- Pregnancy or breastfeeding.
- 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)
- Prior therapy with an anti-PD-1/L1/L2 and/or anti-ICOS directed agent
- Patient is currently participating in another clinical trial.
- Active infection, which significantly affects the patient's clinical condition and requires treatment.
- Patient with prior bone marrow or solid organ transplantation.
- Patient requires immunosuppressive agents, including steroids (daily dose of prednisone or equivalent \> 10 mg)
- Known immunodeficiency including HIV/AIDS(human immunodeficiency virus/acquired immunodeficiency syndrome) infection.
- Patient received any live vaccine within 28 days before enrollment.
- Heart Failure - NYHA(New York Heart Association functional classification system) III or IV
- 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.
- Other comorbidities symptoms or conditions that in Investigator's judgement prevent patient from participation in clinical trial.
Key Trial Info
Start Date :
August 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04875611
Start Date
August 26 2021
End Date
December 31 2025
Last Update
April 24 2025
Active Locations (4)
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1
Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku
Bialystok, Poland
2
Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego
Gdansk, Poland
3
Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
Gliwice, Poland, 44-101
4
Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii
Kielce, Poland