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

NCT ID: NCT04875611

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-26
• Study Completion Date: 2025-12-31

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.

Conditions

Nasopharyngeal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental therapy:OPDIVO (Nivolumab)

Group Type: EXPERIMENTAL

Opdivo

Intervention Type: DRUG

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).

Interventions

Opdivo

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).

Intervention Type: DRUG

Other Intervention Names

Nivolumab

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KCRI

OTHER

Sponsor Role: collaborator

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Klinika Hematologii z Pododziałem Chorób Naczyń Uniwersyteckiego Szpitala Klinicznego w Białymstoku

Bialystok, , Poland

Site Status: RECRUITING

Klinika Hematologii i Transplantologii Gdańskiego Uniwersytetu Medycznego

Gdansk, , Poland

Site Status: RECRUITING

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

Gliwice, , Poland

Site Status: RECRUITING

Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii

Kielce, , Poland

Site Status: RECRUITING

Countries

Poland

Facility Contacts

Ewa Sierko, dr hab.n. med.

Role: primary

esierko@onkologia.bialystok.pl

856646720

Rafał Dziadziuszko, Prof.dr hab.n.med.

Role: primary

rafald@gumed.edu.pl

585844510

Tomasz Rutkowski, Dr hab. n.med.

Role: primary

Tomasz.rutkowski@io.gliwice.pl

604077641

Piotr Kędzierawski, dr n. med.

Role: primary

piotrkedzierawski@wp.pl

413674740

Other Identifiers

20-NIO-0003

Identifier Type: -

Identifier Source: org_study_id