NCT03843515

Neoadjuvant Nivolumab for Oral Cancer Combined With FDG and Anti-PD-L1 PET/CT Imaging for Response Prediction

"Safety and Tolerability of Neoadjuvant Nivolumab for Locally Advanced Resectable Oral Cancer Combined With [18F] BMS-986192 / [18F] -FDG PET Imaging and Immunomonitoring for Response Prediction"

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Safety and tolerability of neoadjuvant nivolumab for locally advanced resectable oral cancer, combined with \[18F\]BMS-986192 / \[18F\]-FDG PET imaging and immunomonitoring for response prediction

Detailed description

Intensive treatment regimens with surgical resection and adjuvant (chemo)radiotherapy of patients with locally advanced oral cancer still result in only 50-60% cure rate, leaving a substantial group of patients who will develop a local recurrence or distant metastases with minimal curative salvage treatment options. Treatment with anti-PD-1 monoclonal antibodies (mAbs) has shown promise in patients with recurrent/metastatic head and neck squamous cell carcinoma (r/m HNSCC). This supports the hypothesis that including treatment with anti PD-1 mAb nivolumab could improve the outcome for patients with locally advanced oral cancer resulting in a higher cure rate. Response rate with nivolumab was below 20% in unselected patients with r/m HNSCC. Therefore, biomarkers for response are urgently needed. Tumor PD-L1 immunohistochemistry (IHC) was shown to be related to nivolumab response but cannot be reliably used for patient selection. Temporal and spatial heterogeneity of tumor PD-L1 expression (within and between tumor lesions) might be responsible for its suboptimal predictive value as biomarker of response. Therefore there is a need to further evaluate tumor PD-L1 expression as predictive biomarker, as well as exploring alternatives. Serial PET imaging with \[18F\]BMS-986192 (anti-PD-L1 tracer) and \[18F\]-FDG has the potential to provide whole body information of the patient over time, at baseline as well as on treatment and represents a biomarker for toxicity and efficacy. In addition, we will investigate the immunophenotype of the patient and tumor, as well as the presence of neoantigens and other potential other biomarkers such as plasma vesicle miRNAs.

Conditions

• Oral Cavity Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Nivolumab	Neoadjuvant nivolumab flat dose 400mg

Timeline

• Start date: 2019-04-11
• Primary completion: 2021-11-30
• Completion: 2022-08-31
• First posted: 2019-02-18
• Last updated: 2021-10-08

Locations

1 site across 1 country: Netherlands