Neoadjuvant Pembrolizumab and IO102-103 for Squamous Cell Carcinoma of the Head and Neck (
This research is being done to see if it is safe to give investigational combination of study drugs (Pembrolizumab and IO102-103) before surgery to people with surgically resectable (removable) newly diagnosed or recurrent metastatic SCCHN. This will be done by watching participants closely for possible side effects fr
| Condition(s) | Head and Neck Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This research is being done to see if it is safe to give investigational combination of study drugs (Pembrolizumab and IO102-103) before surgery to people with surgically resectable (removable) newly diagnosed or recurrent metastatic SCCHN. This will be done by watching participants closely for possible side effects from Pembrolizumab and IO102-103. In addition, participants will be monitored for any delays to their surgery due to the study drugs. |
| Who can participate | Inclusion Criteria: * Be willing and able to provide written informed consent/assent for the trial. * Be 18 years of age on day of signing informed consent. * Patients with non-bulky/non-bulky squamous cell carcinomas of the head and neck, with an indication for surgical therapy. 1. Surgically resectable disease - generally that is T1N1-N2B, T2-4N0-N2b stage are generally eligible (AJCC 7th), however exceptions can be made after approval by the PI for surgically appropriate cases. 2. If determined per tumor board that a low-volume/non-bulky tumor of another stage is appropriate for resection (e.g. small volume T4 with a small amount of bone invasion) such tumors may also be considered for this study if recommendation in tumor board is such. * Be appropriate candidates for resection and cur |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Locations | Washington D.C., District of Columbia, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Portland, Oregon, United States; Philadelphia, Pennsylvania, United States |
| Start date | 2023-12-14 |
| NCT ID | NCT05977907 |
| Official listing | https://clinicaltrials.gov/study/NCT05977907 |