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WGA in Platinum-refractory HNSCC Underwent Nivolumab

NCT03917537 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2019-04-25

No results posted yet for this study

Summary

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.

Conditions

  • HNSCC

Interventions

GENETIC

HNSCC patients have used Nivolumab

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

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Tsang-Tang Hsieh, M.D. · Chang Gung Memorial Hospital

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2021-03-31
Completion
2022-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03917537 on ClinicalTrials.gov