“Immunotherapy and SBRT for Metastatic Head and Neck Carcinomas”
Immunotherapy targeting the PD-1/PD-L1 pathway had previously been shown to be efficacious in the treatment of patients with metastatic head and neck squamous cell carcinomas. Stereotactic Body Radiotherapy (SBRT) to metastatic lesions causes localized cancer cell killing and the release of cancer cell debris, which could stimulate the immune system in the presence of immunotherapy. The purpose of this study is to assess the tolerability and efficacy of combining Durvalumab (MEDI4736), Tremelimumab and SBRT in controlling cancer progression. SBRT will be administered to patients while they are receiving Durvalumab and Tremelimumab.
Radiation - SBRT
SBRT to 2-5 oligometastases will be administered between Cycle 2 and 3 of durvalumab and tremelimumab. All SBRT will be completed within a 3-week period.
Drug - Durvalumab
Durvalumab (1500 mg IV q4weeks) for 4 cycles in combination with tremelimumab. Then, durvalumab alone until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria met.
Drug - Tremelimumab
Tremelimumab (75mg IV q4weeks) for 4 cycles in combination with Durvalumab.
Phase I/II of Durvalumab (MEDI4736) + Tremelimumab + Stereotactic Body Radiotherapy for Metastatic Head and Neck Carcinoma