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WGA in Platinum-refractory HNSCC Underwent Nivolumab

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ClinicalTrials.gov Identifier: NCT03917537
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment
HNSCC Genetic: HNSCC patients have used Nivolumab

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Group/Cohort Intervention/treatment
HNSCC patients have used Nivolumab
Retrospectively analyze WGS information from cancer tissues from HNSCC patients have used Nivolumab
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




Primary Outcome Measures :
  1. Prediction rate of Nivolumab Response [ Time Frame: 2-4 months ]
    Prediction rate of Nivolumab Response


Secondary Outcome Measures :
  1. Adverse effects (types and grading) of Nivolumab [ Time Frame: 2-4 months ]
    Adverse effects (types and grading) of Nivolumab


Biospecimen Retention:   Samples With DNA
  1. The study will retrieve cancer tissues from HNSCC patients received threshold Nivolumab. WGS by Illumina HighSeq X Ten Platform will be used for exploring biomarkers of Nivolumab.
  2. All Samples will be collected from pathologic departments from participating hospitals, including 10μm x 5-10 slices non-coating, 3μm x 3 slices for PD-L1 staining.
  3. Also, Pathologist will involve PD-L1 IHC staining (Ventana SP 263) and grading.
  4. Cancer Tissues will be sent for WGS analysis (Application for sampling tests will be sent and obtained.)
  5. Data will be sent to biostatistics analysis company or experts for analysis with charges.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Retrospectively analyze WGS information from cancer tissues from HNSCC patients have used Nivolumab
Criteria

Inclusion Criteria:

  • Age above 20 years old

Exclusion Criteria:

  • Age below 20 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917537


Contacts
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Contact: Jason Chia-Hsun Hsieh, M.D. Ph.D. +886-33281200 ext 2517 wisdom3000cgmh@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: CHIA-HSUN HSIEH, MD,PhD    +886975366137    wisdom3000cgmh@gmail.com   
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Tsang-Tang Hsieh, M.D    +886-33281200 ext 8825    sally6869@cgmh.org.tw   
Contact: Chia-Hsun Hsieh, M.D,M.S.    +886-33281200 ext 8825    wisdom5000@gmail.com   
Principal Investigator: Chia-Hsun Hsieh, M.D., M.S         
Sub-Investigator: Min-Hsien Wu, PhD.         
Sub-Investigator: Hung-Ming Wang, M.D.         
Sub-Investigator: Siang-Fu Huang, M.D.,PhD.         
Sub-Investigator: Yonɡ-Chanɡ Lin, M.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Tsang-Tang Hsieh, M.D. Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03917537     History of Changes
Other Study ID Numbers: PRECISION-01
First Posted: April 17, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chang Gung Memorial Hospital:
programmed death 1 (PD-1)
programmed death ligand 1 (PD-1)
Nivolumab
Pembrolizumab
immune-related adverse events (irAEs)
whole-genome sequencing (WGS)
Circulating tumor cells (CTCs)
Platinum-refractory

Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents