Immunotherapy and Stereotactic Body Radiotherapy (SBRT) for Metastatic Anaplastic Thyroid Cancer

Conditions

• Metastatic Anaplastic Thyroid Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• durvalumab — DRUG
  Patients will receive durvalumab (MEDI4736) and tremelimumab together every 4 weeks.
• tremelimumab — DRUG
  Patients will receive durvalumab (MEDI4736) and tremelimumab together every 4 weeks.
• Stereotactic Body Radiotherapy (SBRT) — RADIATION
  SBRT at 9Gy x 3 per standard of care given within 2 weeks after the completion of Cycle 1 of durvalumab (MEDI4736) and tremelimumab

Study Details

The purpose of this study is to test the safety of durvalumab (MEDI4736) and tremelimumab in combination with radiation therapy and find out what effects, if any, this combination has on people, and whether it improves overall survival.

Key Dates

Start date

Apr 25, 2017

Status verified

Jun 2022

Primary completion

Jun 3, 2022

Completion

Jun 3, 2022

Study Design

Enrollment

13 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: durvalumab (MEDI4736) & tremelimumab with SBRT
  Patients will receive durvalumab (MEDI4736) and tremelimumab together every 4 weeks. SBRT delivered to one metastatic site per standard of care using a standard 9Gy x 3 fractions will be given within 2 weeks after the completion of the first cycle of durvalumab (MEDI4736) and tremelimumab. After 4 cycles of durvalumab (MEDI4736) and tremelimumab, patients will then continue with single agent durvalumab (MEDI4736) every 4 weeks until disease progression or unacceptable toxicity or a total of 12 months from date of initial treatment.

Primary Outcome Measure

overall survival [ Time Frame: 1 year ]

Locations (8)

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