Clinical trial · Observational
WGA in Platinum-refractory HNSCC Underwent 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HNSCC patients have used Nivolumab | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- HNSCC patients have used Nivolumab
- description
- Retrospectively analyze WGS information from cancer tissues from HNSCC patients have used Nivolumab
- interventionNames
- Genetic: HNSCC patients have used Nivolumab
Primary outcomes (1)
- measure
- Prediction rate of Nivolumab Response
- timeFrame
- 2-4 months
- description
- Prediction rate of Nivolumab Response
Secondary outcomes (1)
- measure
- Adverse effects (types and grading) of Nivolumab
- timeFrame
- 2-4 months
- description
- Adverse effects (types and grading) of Nivolumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age above 20 years old Exclusion Criteria: * Age below 20 years old
References
Publications (0)
Data not yet available