CHEckpoint Inhibition in Combination With an Immunoboost of External Beam Radiotherapy in Solid Tumors

Sponsor
University Hospital, Ghent
Study ID
NCT03511391
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Nivolumab or Pembrolizumab or Atezolizumab — DRUG
    per national standard of care
  • SBRT — RADIATION
    Stereotactic body radiotherapy is administered to maximally 3 lesions in 3 fractions of 8Gy prior to the second/third cycle of checkpoint inhibitors.

Study Details

This randomized controlled phase II trial will investigate whether the addition of stereotactic body radiotherapy to checkpoint inhibitor treatment in patients with non-small-cell lung carcinoma, urothelial carcinoma, renal cell carcinoma, melanoma or head-and-neck carcinoma can improve progression-free survival as compared to checkpoint inhibitor monotherapy. The primary outcome is progression-free survival; secondary outcomes include overall survival, response according to iRecist and Recist v1.1 and toxicity.

Key Dates

Start date
Mar 9, 2018
Status verified
Jan 2024
Primary completion
Feb 1, 2022
Completion
Jan 23, 2024

Study Design

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

Arms

  • Experimental: Experimental arm
    Stereotactic body radiotherapy concurrent with checkpoint inhibitor treatment: Nivolumab or Pembrolizumab or Atezolizumab + SBRT
  • Active Comparator: Control arm
    Checkpoint inhibitor treatment only: Nivolumab or Pembrolizumab or Atezolizumab monotherapy

Primary Outcome Measure

Progression-free survival [ Time Frame: 15 months ]

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