DENOSUMAB IN EBV RELATED NASOPHARYNGEAL CARCINOMA (NPC) AS A MODEL FOR RANK-MEDIATED IMMUNOLOGIC MODULATION OF VIRUS-RELATED TUMOURS – DERN STUDY

Phase 1

• Conditions: advanced or metastatic Nose Pharynx Cancer; MedDRA version: 21.0Level: LLTClassification code 10028793Term: Nasopharyngeal carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-005017-31-IT
• Lead Sponsor: G.O.N.O. - GRUPPO ONCOLOGICO DEL NORD OVEST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 7 September 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

1.EBV related nasopharyngeal cancer
2.Detectable and quantifiable plasmatic EBV DNA
3.Recurrent and/or metastatic disease not suitable for curative treatment
4.PS < 2
5.Suitable for polychemotherapy
6.Age = 18 years
7.Informed consent signed
8.Subject has adequate organ functions, evidenced by the following:
a.AST (SGOT), ALT (SGPT) = 2.5 x upper limit of normal range (ULN), or = 5 x ULN range if liver metastasis present
b.Total bilirubin = 1.5 x ULN
c.creatinine clearance 24/h > 50 mL/min
d.Total serum calcium > 8.8 mg/dL
e.Absolute neutrophil count = 1.5 x 10*9 cells/L
f.Platelets = 100 x 10*9 cells/L
g.Haemoglobin = 9 g/dL
9.If of childbearing potential, willingness to use effective contraceptive method (Pearl Index < 1; e.g. oral contraceptive (pill), hormone spiral, hormone implant, transdermal patch, a combination of two barrier methods (condom and diaphragm), sterilisation, sexual abstinence) for the study duration and 5 months post-dosing.
10.Subject understands and voluntarily signs an ICF prior to any study-related assessments/procedures are conducted.
11.Subject is able to adhere to the study visit schedule and other protocol requirements.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1. Having received 1 or more chemotherapy line for recurrent/metastatic disease
2.Any residual CTCAE grade = 2 toxicity
3.Subject has any other malignancy within 3 years prior to randomization, with the exception of adequately treated in situ carcinoma of the cervix, uteri, or non-melanoma skin cancer (all treatment of which should have been completed 6 months prior to enrolment), in situ squamous cell carcinoma of the breast, or incidental prostate cancer T1a, Gleason < 7, PSA <10 ng/ml.
4.Subject has had radiotherapy = 4 weeks or limited field radiation for palliation = 2 weeks prior to starting IP, and/or from whom = 30% of the bone marrow was irradiated.
5.Having participated in another clinical trial or having received any investigational agent in the preceding 30 days before study entry.
6.Chronic systemic immunosuppressive therapy that cannot be interrupted during treatment study.
7.Subject has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure.
8.Subject has a known or suspected hypersensitivity to study drugs.
9.Subject is pregnant or breast feeding.
10.Subject is receiving prohibited medication as per section 7.4.2 and suspension of such treatment is considered unsafe.
11.Subject has history of prior or current osteonecrosis of the jaw (ONJ).
12.Subject has history of prior irradiation to the mandible, specified as:
Dose constraints to the mandible: Dmax = 70 Gy, V50 = 62 Gy and V60 = 20 Gy
Mandible should be contoured as whole organ, with alveolar bone, excluding teeth.
13.Subject has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator’s judgment, contraindicate subject participation in the clinical study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified