Clinical trial · Interventional
HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer
HFHS-1801-A Pilot Study of Immunotherapy As Consolidation Therapy for Patients with Recurrent Head and Neck Cancer High Risk Pathologic Features Following Surgical Salvage and Are Not Eligible for Post-operative Radiation Therapy
NCT04188951CI-TRIAL-00083313completedEarly Phase 1ClinicalTrials.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 study is a pilot study to explore the feasibility and efficacy of immunotherapy following salvage surgery for recurrent head and neck cancer.
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 Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA] | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
- interventionNames
- Drug: Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]
Primary outcomes (1)
- measure
- Rate of recurrence at 1 year, will be measured by RECIST 1.1 as the primary measure for assessment of tumor, date of disease progression, and as a basis for all protocol guidelines related to disease status (e.g., discontinuation of study treatment).
- timeFrame
- 1 year
- description
- Primary objective
Secondary outcomes (3)
- measure
- Determine the feasibility of immunotherapy for head and neck cancer following salvage surgery to produce preliminary data for 15 patients regarding efficacy. All side effects and symptoms will be assessed by CTCAE v5.0.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be 18 years or older, of either gender, with the ability to consent to participation in the study. * Patients must have a history of squamous cell carcinoma of the head and neck involving any sub-site in the head and neck area except nasopharynx, paranasal sinuses, and salivary gland tumors. * All patients must have recurred following definitive therapy with any combination of surgery, radiation, and/or chemotherapy. * All patients must have undergone salvage surgery in an attempt to excise all recurrent disease. * Salvage radiation therapy must not be an option available to the patient. * Patients must have high risk features such extra nodal invasion, positive margins, perineural invasion or vascular embolism. Exclusion Criteria: * Patients with macroscopic residual disease * Patient is eligible for radiation therapy. * Performance status more than 2. * Contraindications for immunotherapy, autoimmune disease, allergy to medication, steroid use at baseline. * Patients with other previous cancers excluding CIN, DCIS, non-melanoma skin cancers * Patients previously treated with immunotherapy \<12months prior * Patients with synchronous cancers "not included in the inclusion criteria"
References
Publications (0)
Data not yet available
No reference posted for this study.