Phase II Study Evaluating the Efficacy of Nivolumab in the Treatment of Patients With Nasopharyngeal Cancer Who Progressed During or After Platinum-based Chemotherapy

Maria Sklodowska-Curie National Research Institute of Oncology4 sites in 1 country32 target enrollmentAugust 26, 2021

ConditionsNasopharyngeal Cancer

InterventionsOpdivo

DrugsOpdivo

Overview

Phase: Phase 2
Intervention: Opdivo
Conditions: Nasopharyngeal Cancer
Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Enrollment: 32
Locations: 4
Primary Endpoint: Objective response rate (ORR)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 26, 2021

End Date

December 31, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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

Arms & Interventions

Experimental therapy:OPDIVO (Nivolumab)

Intervention: Opdivo

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: 12 weeks

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

Secondary Outcomes

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)
DoR(duration of response) per RECIST (Response Evaluation Criteria in Solid Tumours)(through study completion, an average of 1 year)
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)
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))
Safety assessment of treatment with Nivolumab measured by excesive toxity(Each visit during treatment phase -12 cycles of investigation product's infusion (around 6 month of treatment).)