Clinical trial · Interventional
Adjuvant Nivolumab After Salvage Resection in Head and Neck Cancer Patients Previously Treated With Definitive Therapy
A Single Arm Phase 2 Study of Adjuvant Nivolumab After Salvage Resection in Head and Neck Squamous Cell Carcinoma Patients Previously Treated With Definitive Therapy
NCT03355560CI-TRIAL-00110649completedPhase 2Results postedClinicalTrials.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)
The purpose of this research study is to test the safety and efficacy of nivolumab after salvage resection in head and neck cancer in patients that have previously received definitive radiation with or without chemotherapy.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab
- description
- Nivolumab starting 4-11 weeks after surgery for 6 doses.
- interventionNames
- Drug: Nivolumab
Primary outcomes (1)
- measure
- Percentage of Patients With Grade 3 and 4 Adverse Events of Nivolumab
- timeFrame
- AEs were collected during the treatment period and for a minimum of 30 days following the last dose of study treatment, up to 7 months.
- description
- As determined by CTCAE v5.0 and Grade 3 or 4 adverse event rate was determined by counting the number of subjects that had at least one Grade 3 or Grade 4 adverse while on treatment of nivolumab.
Secondary outcomes (3)
- measure
- Percentage of Patients With Any Grade Adverse Events of During Treatment of Nivolumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Prior definitive therapy with radiation (with or without prior surgical resection and/or chemotherapy) who have underwent salvage resection with curative intent and have no other curable options * Pre-operative scans including chest imaging preferably PET/CT and CT neck w/contrast. MRI neck is acceptable if contrast contraindicated. * Able to provide archived biopsy or resected tissue. * Adequate performance status and labs. Exclusion Criteria: * Patients who did not receive at least radiotherapy as prior definitive treatment. * Patients who have gross measurable residual disease after surgery or those who underwent surgery for palliative purposes i.e. for symptom control. * Has nasopharyngeal or sinonasal carcinoma. * Has confirmed metastatic disease.
References
Publications (1)
- DERIVEDLeddon JL, Gulati S, Haque S, Allen C, Palackdharry S, Mathews M, Kurtzweil N, Riaz MK, Takiar V, Nagasaka M, Patil Y, Zender C, Tang A, Cervenka B, McGrath J, Korn WM, Hinrichs BH, Jandarov R, Harun N, Sukari A, Wise-Draper TM. Phase II Trial of Adjuvant Nivolumab Following Salvage Resection in Patients with Recurrent Squamous Cell Carcinoma of the Head and Neck. Clin Cancer Res. 2022 Aug 15;28(16):3464-3472. doi: 10.1158/1078-0432.CCR-21-4554. PMID 35653116