Consolidation Nivolumab After Concurrent Chemoradiotherapy in Locally 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
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
Treatments tested in this trial
- Nivolumab
Treatment groups
57 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov