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

NCT04875611 | Recruiting Phase 2

• 1 other identifier: 20-NIO-0003
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Percentage of objective responses (partial and complete responses combined /partial response (PR)+ complete response(CR)/ by immune Response Evaluation Criteria in Solid Tumours (iRECIST) response criteria) in MRI (Magnetic Resonance Imaging) after 12 weeks. 1. Partial response - at least a 30% decrease in the sum of the LD(longest diameter) of target lesions, taking as reference the baseline sum LD(longest diameter) 2. Complete response (CR)- disappearance of all target lesions and short dimension of all lymph nodes \< 10 mm

  12 weeks

Secondary Outcomes (6)

• 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.

  6 month of treatment phase

• Overall survival (OS) rate- time of total survival

  at 6 months (treatment phase), 12 months and 18 months (6th month and 12th month of long term follow up)

• DCR(disease control rate) per RECIST (Response Evaluation Criteria in Solid Tumours)

  through study completion, an average of 6 months

• DoR(duration of response) per RECIST (Response Evaluation Criteria in Solid Tumours)

  through study completion, an average of 1 year

• 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.

  from first infusion to last follow up ( 3 month, 6 month, 9 month,12month follow up)

Study Arms (1)

Experimental therapy:OPDIVO (Nivolumab)

EXPERIMENTAL

Drug: Opdivo

Interventions

Opdivo 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).

Also known as: Nivolumab

Experimental therapy:OPDIVO (Nivolumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• KCRI: collaborator

Study Sites (4)

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, 44-101, Poland

RECRUITING

Klinika Hematologii i Transplantacji Szpiku, Świętokrzyskie Centrum Onkologii

Kielce, Poland

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: May 6, 2021
• Study Start: August 26, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

PL (4)