Table 2.
Illustrative listing of clinical trials examining impact of combining immunotherapy in salvage surgery setting in recurrent head and neck cancers.
| Sl No | NCT number | Title | Phase | Outcome measure | Status |
|---|---|---|---|---|---|
| 1 | NCT04754321 | Pembrolizumab and Radiation therapy before and during surgery for treatment of persistent or recurrent head and neck cancer | I | Incidence of adverse events Progression free survival Overall survival Local control rate Health related quality of life |
Not yet recruiting |
| 2 | NCT04671667 | Testing what happens when an immunotherapy drug is added to radiation or given by itself compared to usual treatment of chemotherapy with radiation after surgery for recurrent head and neck squamous cell carcinoma | II | Incidence of adverse events Overall survival Disease free survival |
Recruiting |
| 3 | NCT04188951 | A pilot study of immunotherapy as consolidation therapy for patients with recurrent head and neck cancer | I | Toxicity rates Determine feasibility of immunotherapy after salvage surgery in recurrent head and neck tumors |
Recruiting |
| 4 | NCT03565783 | Cemiplimab in treating participants with recurrent stage III-IV Head and neck squamous cell cancer before surgery | II | Overall response rate Time to recurrence Patterns of failure Disease-specific survival ∙Disease-free survival Overall survival |
Recruiting |
| 5 | NCT03003637 | ImmunoModulation by the Combination of Ipilimumab and Nivolumab Neoadjuvant to Surgery In Advanced or Recurrent Head and Neck Carcinoma | I / II | Phase I: number of patients that will endure a delay in surgery due to immunotherapy related toxicity Phase II: Tumor response to neoadjuvant immunotherapy in terms of tumor tissue pathological response at time of surgery compared to RECIST 1.1 (FDG-PET and perfusion and diffusion weighted MRI). |
Completed |
| 6 | EudraCT 2017-0012711-17 [Gustave Roussy- France] | Adjuvant immunotherapy after salvage surgery in head and neck squamous cell carcinoma : phase 2 trial evaluating the efficacy and the toxicity of nivolumab alone, and of the combination nivolumab and ipilimumab | II | Toxicity profile Overall and Disease free survival Quality of life |
On going |
RECISTs, response evaluation criteria in solid tumors; FDG-PET, fluorodeoxyglucose-PET.