Stereotactic Body Radiotherapy (SBRT) Followed by Immunotherapy in Liver Cancer

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT03203304
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    240mg every two weeks by IV infusion
  • Ipilimumab — DRUG
    1mg/kg every six weeks by IV infusion

Study Details

External beam photon stereotactic body radiotherapy (SBRT) using a linear accelerator to a total dose of 40 Gy in 5 fractions delivered once daily with at least 48 hours between each fraction. SBRT treatment will be completed within a 21-day window. Starting within 14 days after completion of SBRT, intravenous nivolumab 240 mg will be given every 2 weeks as monotherapy or in combination with ipilimumab 1 mg/kg IV every 6 weeks.

Key Dates

Start date
Aug 25, 2017
Status verified
Jun 2021
Primary completion
Mar 13, 2019
Completion
Mar 13, 2019

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab
    Patients will be randomly placed in either of the two arms. All patients will undergo CT simulation and stereotactic body radiotherapy (SBRT). SBRT treatment will be completed within a 21-day window. After the final fraction of SBRT, patients will receive treatment with nivolumab 240 mg will be initiated within 14 days. Patients will receive nivolumab infusions once every 2 weeks. Patients will be restaged after every 4 doses of nivolumab (every 8 weeks). Treatment beyond progression is allowed as per irRC evaluation.
  • Experimental: Nivolumab and ipilimumab
    Patients will be randomly placed in either of the two arms. All patients will undergo CT simulation and stereotactic body radiotherapy (SBRT). SBRT treatment will be completed within a 21-day window. After the final fraction of SBRT, treatment with nivolumab and ipilimumab will be initiated within 14 days. Patients will be restaged after every 4 doses of nivolumab (every 8 weeks). Treatment beyond progression will be allowed as per irRC evaluation. Patients will receive nivolumab infusions once every 2 weeks and ipilimumab infusions once every 6 weeks.

Primary Outcome Measure

Number of participants with adverse events [ Time Frame: 3 years ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637-
Roswell Park Cancer InstituteBuffaloNew York14263-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Chicago, IL

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
University of Chicago· Chicago, ILRoswell Park Cancer Institute· Buffalo, NYMedical College of Wisconsin· Milwaukee, WI

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