Immunotherapy and SBRT for Metastatic Head and Neck Carcinomas

Official Title

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

Summary:

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 Radiation Therapy (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.

Trial Description

Primary Outcome:

  • Acute toxicities of the treatment
  • Progression Free Survival (PFS)
Secondary Outcome:
  • Local control (LC)
  • Progression-free survival (PFS)
  • Overall survival (OS)
  • Abscopal events

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society