Clinical Trial

Testing Experiemental Skin Cancer Treatment

Study Description

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

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.

Additional Information

Official Study Title

Phase I/II of Durvalumab (MEDI4736) + Tremelimumab + Stereotactic Body Radiotherapy for Metastatic Head and Neck Carcinoma

Clinical Trial ID

NCT03283605

ParticipAid ID

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