Clinical trial NCT04875611: Nivolumab in Nasopharyngeal Cancer With Progression During or After Platinum-based Treatment
Official title: Phase II Study Evaluating the Efficacy of Nivolumab in the Treatment of Patients With Nasopharyngeal Cancer Who Progressed During or After Platinum-based Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Nasopharyngeal Cancer
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: KCRI
First posted: 2021-05-06
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 disqualified from radical therapy . The total number of patients was estimated for 32.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: 12 weeks
Secondary outcomes:
measure: 1.Progression- free survival (PFS) by iRECIST( immune Response Evaluation Criteria in Solid Tumours) criteria- from the beginning of treatment to the progression of disease or death.
timeFrame: 6 month of treatment phase
measure: Overall survival (OS) rate- time of total survival
timeFrame: at 6 months (treatment phase), 12 months and 18 months (6th month and 12th month of long term follow up)
measure: DCR(disease control rate) per RECIST (Response Evaluation Criteria in Solid Tumours)
timeFrame: through study completion, an average of 6 months
measure: DoR(duration of response) per RECIST (Response Evaluation Criteria in Solid Tumours)
timeFrame: through study completion, an average of 1 year
measure: Change in quality of life in EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) (version 3.0) .A high scale score represents a higher response level.
timeFrame: from first infusion to last follow up ( 3 month, 6 month, 9 month,12month follow up)
measure: Safety assessment of treatment with Nivolumab measured by excesive toxity
timeFrame: Each visit during treatment phase -12 cycles of investigation product's infusion (around 6 month of treatment).
Other outcomes:
Locations:
city: Białystok
country: Poland
facility: Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku
city: Gdańsk
country: Poland
facility: Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego
city: Gliwice
country: Poland
facility: Klinika Transplantacji Szpiku i Onkohematologii Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy, Oddział w Gliwicach
city: Kielce
country: Poland
facility: Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii
Study officials:
References: