Health TrialsbyHealthPanel

Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally Advanced Nasopharyngeal Carcinoma

ConditionLocally Advanced Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age19+
SponsorYonsei University

About this trial

The clinical efficacy of nivolumab for locally advanced nasopharyngeal carcinoma patients with residual disease after standard chemoradiotherapy is not known. In this study, we aim to investigate the role of nivolumab in locally advanced NPC after chemoradiotherapy the safety profile and antitumor activity of the anti-programmed death 1 (PD-1) receptor monoclonal antibody, nivolumab after in patients with advanced nasopharyngeal carcinoma

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female

Age (at the time of informed consent): 19 years and older

Subjects with histologically- or cytologically-confirmed advanced Nasopharyngeal cancer (Stage II -IVa) according to 8th edition clinical staging system of the American Joint Committee on Cancer before the start of concurrent chemoradiotherapy

Patients who have recovered from previous toxicities of standard chemoradiotherapy (Grade ≤1).

Disqualifiers

Patients with multiple primary cancers (with the exception of completely resected basal cell carcinoma, stage I squamous cell carcinoma, carcinoma in situ, intramucosal carcinoma, or superficial bladder cancer, or any other cancer that has not recurred for at least 5 years)

Patients with residual adverse effects of prior therapy or effects of surgery that would affect the safety evaluation of the investigational product in the opinion of the investigator or sub-investigator.

Patients with current or past history of severe hypersensitivity to any other antibody products

Patients with concurrent autoimmune disease or history of chronic or recurrent autoimmune disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Nivolumab

    Drug

    Dosage within 12 weeks after the end of concurrent chemoradiation therapy. Nivolumab 360mg Intravenously administered every 3 weeks. As a consolidation regimen, administration of Nivolumab is administered for up to a total of 1 year until disease progression or unacceptable to toxicity occurs.

Treatment groups

57 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) rate at 2years

Progression-free survival rate at 2 years, which is the primary endpoint, will be measured by the proportion of patients who remain progression-free after 2 years of study registration.

Time frame
2 years

Secondary outcomes

1

Object response rate (ORR)

according to RECIST 1.1 criteria

Time frame
Screening, Every 3months during the administration period(up to 1year), every 6 months after the end of the administration(up to 5years)
2

Overall survival (OS)

Overall survival will be followed continuously while subjects are on the study drug and every 6 months after discontinuation or progression for up to 5 years following the start of therapy either by direct contact (office visits) or via telephone contact, until death, withdrawal of study consent, or lost to follow-up.

Time frame
Intervals of 6 months up to 5 years after the end of dosing
3

Subject with Treatment Related Adverse Events as Assessed by CTCAE v5.0

The procedures and assessments may be performed as part of standard of care; however, data for these assessments should remain in the subject's medical record and should not be provided to Ono unless specifically requested. NCI CTCAE Version 5.0 will be the criteria used to assess adverse events.

Time frame
Every cycle (every 3weeks), until 28 days after the end of treatment.
4

Multiplexed biomarker analysis of tumor and immune cells in the TME

To understand correlated expressions of protein markers related to therapy response, multiplexed-image analysis (Vectra Polaris® and inForm®, PerkinElmer) is applied in tumor tissues

Time frame
At screening, At cycle2 day1(each cycle is 28 days), End of treatment (up to a total of 1 year)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yonsei University

Lead sponsor

Source ClinicalTrials.gov
Apply now