WGA in Platinum-refractory HNSCC Underwent Nivolumab

Sponsor
Chang Gung Memorial Hospital
Study ID
NCT03917537
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • HNSCC patients have used Nivolumab — GENETIC
    Using Whole-Genome Analysis on Cancer Tissue of Patients with Platinum-refractory Head and Neck Squamous cell carcinoma Who Underwent Nivolumab to Precisely Predict Responders: An Observational Biomarker Study

Study Details

To choose a subgroup who could clearly benefit from Nivolumab, we are proposing a prospective observational study. Whole-genome study (WGS) analysis will be performed on archived cancer tissues from patients who were (1) cisplatin-refractory and subsequently (2) received Nivolumab (at least 4 doses) and (3) had completed imaging response evaluation at 3-4 month after Nivolumab. The estimated sample size was designed to be 80, including 20 responders and 60 non-responders (1:3 design) after Nivolumab alone at a dosage of 2-3mg/kg every 2 weeks (+/- 7 days could be allowed), given the minimal requirement of statistical significance. The specific bio-signature(s) found in this prospective observational study could possibly greatly contribute to precision immuno-oncology medicine, especially Nivolumab.

Key Dates

Start date
Apr 1, 2018
Status verified
Jul 2018
Primary completion
Mar 31, 2021
Completion
Mar 31, 2022

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: HNSCC patients have used Nivolumab
    Retrospectively analyze WGS information from cancer tissues from HNSCC patients have used Nivolumab

Primary Outcome Measure

Prediction rate of Nivolumab Response [ Time Frame: 2-4 months ]

Central Contacts

Related Studies