Clinical trial · Observational
Predictive Biomarkers for Response to Nivolumab in Head and Neck Squamous Cell Carcinoma
Predictive Biomarkers For Response To Nivolumab In Head and Neck Squamous Cell Carcinoma
NCT03652142CI-TRIAL-00034632unknownClinicalTrials.gov clinicaltrialsProvenance
- 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)
Nivolumab is FDA-approved for the treatment of patients with recurrent/metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). HNSCC whose disease has progressed within 6 months after platinum-based chemotherapy. The development of predictive biomarkers is needed to optimize patient benefit, minimize risk of toxicities and guide combination strategies.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DNA Damage | — | UNRESOLVED | — |
| DNA Double Strand Break | — | UNRESOLVED | — |
| HNSCC | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biomarker Research | Other | — | UNRESOLVED |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Recurrent/metastatic HNSCC
- description
- The investigators will include recurrent/metastatic HNSCC patients who progressed after cisplatin-based chemotherapy and are to be treated with nivolumab. Tumor biopsies will be performed at baseline, after the second cycle and at progression with appropriate written informed consent and the samples will be analyzed. Biomarker research will be performed. The patients will receive intravenously nivolumab at dose of 240 mg every 2 weeks (240mg q2w). The patients will undergo tumor biopsy at baseline and within 24-72h after the second administration of treatment, and at progression of their disease.
- interventionNames
- Other: Biomarker Research
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Change in the percentage of immune cells in post treatment compared to baseline biopsies
- timeFrame
- 2 weeks
- description
- Primary endpoint will be the change in mean percentage of immune cells that is caused by the nivolumab treatment
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent before any trial-related procedure is undertaken * Male or female subjects aged ≥18 years * Availability of a formalin-fixed, paraffin-embedded tissue sample (FFPE) containing tumor Exclusion Criteria: * no inform consent provided
References
Publications (1)
- BACKGROUNDHamid O, Schmidt H, Nissan A, Ridolfi L, Aamdal S, Hansson J, Guida M, Hyams DM, Gomez H, Bastholt L, Chasalow SD, Berman D. A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med. 2011 Nov 28;9:204. doi: 10.1186/1479-5876-9-204. PMID 22123319