Table 2.
Selected combination SBRT-immunotherapy clinical trials in head and neck cancer.
| NCT ID | Title | Phase | Patients enrolled | HNSCC population | Number of SBRT fractions | Total SBRT dose | Sequence of treatments |
|---|---|---|---|---|---|---|---|
| NCT04576091 | Testing the Addition of an Anti-cancer Drug, BAY 1895344, With RT to the Usual Pembrolizumab Treatment for Recurrent HN Cancer | 1 | 37 | Recurrent unresectable | 3 | IT on day 1 of 1st cycle, BAY1895344 starting day 7 of 1st cycle, SBRT starting day 2–8 of 2nd cycle | |
| NCT03283605 | IT and SBRT for Metastatic HN Carcinomas | 1/2 | 45 | Metastatic | SBRT after 2 cycles of IT | ||
| NCT03212469 | A Trial of Durvalumab and Tremelimumab in Combination With SBRT in Patients With Metastatic Cancer | 1/2 | 54 | Metastatic | IT starting day 1, SBRT staring day 15 | ||
| NCT04830267 | The Efficacy of Camrelizumab Plus SBRT in R/M HNSCC | 2 | 70 | R/M | 3 | 27 Gy | IT starting day 1, SBRT starting day 14 |
| NCT02684253 | Screening Trial of Nivolumab With Image Guided SBRT Versus Nivolumab Alone in Patients With Metastatic HNSCC | 2 | 65 | Metastatic | 3 | 27 Gy | IT starting day 1, SBRT starting day 14 |
| NCT03546582 | SBRT ± Pembrolizumab in Patients With Local-Regionally Recurrent or Second Primary HN carcinoma | 2 | 102 | Recurrent or new second primary | SBRT for 2 weeks, followed by IT | ||
| NCT04862455 | NBTXR3, Radiation Therapy, and Pembrolizumab for the Treatment of Recurrent or Metastatic HNSCC | 2 | 60 | R/M | Injection of NBTXR3 on day 1, SBRT with concurrent IT starting day 3–8 | ||
| NCT05136768 | Sintilimab Combined With Chemotherapy and SBRT in Limited Metastatic HNSCC | 2 | 50 | Limited metastatic | IT and chemotherapy starting day 1, SBRT starting after at least 2 cycles of IT and chemotherapy | ||
| NCT03313804 | Priming Immunotherapy in Advanced Disease With Radiation | 2 | 57 | Metastatic | 30 Gy | IT starting day 1, SBRT starting day 1–14 | |
| NCT03635164 | RT With Durvalumab Prior to Surgical Resection for HPV Negative Squamous Cell Carcinoma | 1 | 21 | HPV negative resectable | 2 (escalate to 3) | 12 Gy (escalate to 18 Gy) | Neoadjuvant IT + SBRT, followed by surgery at 3–6 weeks after SBRT |
| NCT05053737 | RT in Combination With Atezolizumab Prior to Surgical Resection for HPV Unrelated HNSCC | 1/2 | 46 | HPV negative | 3 | 24 Gy | Neoadjuvant IT + SBRT, followed by surgery |
| NCT04938609 | Neoadjuvant Immunoradiotherapy in HN Cancer (NIRT 2-HNC) | 2 | 28 | Stage III-IVa HPV negative | 3 | 24 Gy | Neoadjuvant IT + SBRT, followed by surgery at week 7 |
| NCT03618134 | SBRT and Durvalumab With or Without Tremelimumab Before Surgery in Treating Participants With Human Papillomavirus Positive Oropharyngeal Squamous Cell Caner | 1/2 | 82 | HPV positive resectable oropharyngeal | Neoadjuvant IT + SBRT, followed by TORS and neck dissection between weeks 6–8 |
HN, head and neck; HNSCC, head and neck squamous cell carcinoma; IT, immunotherapy; R/M, recurrent or metastatic; RT, radiation therapy; SBRT, stereotactic body radiation therapy; TORS, transoral robotic surgery.