Table 1.
Current clinical trials of immunotherapy with radiation for primary and metastatic CNS malignancy.
| Study phase | Institution/group | ClinicalTrials.gov ID | Disease site | Cohorts | Planned accrual | IT mechanism | Est. completion date | Primary outcome measure |
|---|---|---|---|---|---|---|---|---|
| II | Multi-institutional (CheckMate548) | NCT02667587 | Newly diagnosed glioblastoma | Nivolumab + temozolomide + RT vs. placebo + temozolomide + RT | n = 320 | anti-PD-1 | May 2017 | OS |
| III | Multi-institutional (CheckMate498) | NCT02617589 | Newly diagnosed glioblastoma | Nivolumab + RT vs. temozolomide + RT | n = 550 | anti-PD-1 | October 2019 | OS |
| II | Ludwig Institute for Cancer Research | NCT02336165 | Newly diagnosed, recurrent glioblastoma | MEDI4736 vs. MEDI4736 + standard RT vs. MEDI4736 + bevacizumab | n = 108 | anti-PD-1 | July 2017 | OS, PFS |
| I/II | Northwestern University | NCT02530502 | Newly diagnosed glioblastoma | RT + temozolomide + pembrolizumab → temozolomide + pembrolizumab | n = 50 | anti-PD-1 | March 2018 | Dosage, PFS, OS |
| I | H. Lee Moffitt Cancer Center | NCT02313272 | Recurrent glioma | HFSRT + pembrolizumab + bevacizumab | n = 32 | anti-PD-1 | June 2017 | Dosage |
| I/II | MD Anderson Cancer Center | NCT02696993 | NSCLC BM | Nivolumab + SRS; nivolumab + WBRT; nivolumab + ipilimumab + SRS; nivolumab + ipilimumab + WBRT | n = 130 | anti-PD-1; anti-CTLA-4 | April 2020 | Dosage; PFS |
| II | Grupo Español Multidisciplinar de Melanoma (GEM) | NCT02115139 | Melanoma BM | Ipilimumab + WBRT | n = 66 | anti-CTLA-4 | October 2016 | 1-year survival rate |
| II | University of Michigan Cancer Center | NCT02097732 | Melanoma BM | Ipilimumab → SRS → ipilimumab vs. SRS → ipilimumab | n = 40 | anti-CTLA-4 | May 2017 | Local control rate |
| I | Thomas Jefferson University | NCT01703507 | Melanoma BM | Ipilimumab + WBRT vs. ipilimumab + SRS | n = 24 | anti-CTLA-4 | November 2017 | Dosage |
| I | Sidney Kimmel Comprehensive Cancer Center | NCT01950195 | Melanoma BM | Ipilimumab + SRS | n = 30 | anti-CTLA-4 | December 2016 | Adverse events and safety |
| II | University Hospital, Lille | NCT02662725 | Melanoma BM | Ipilimumab + SRS | n = 73 | anti-CTLA-4 | December 2015 | OS |
RT, radiation therapy; PD-1, programmed cell death protein 1; OS overall survival, PFS, progression-free survival; HFSRT, hypofractionated stereotactic radiotherapy; IMRT, intensity-modulated radiation therapy; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; irRC, immune-related response criteria; WBRT, whole brain radiation therapy; NSCLC, non-small cell lung cancer; BM, brain metastases; SRS, stereotactic radiosurgery; MM, metastatic melanoma; SBRT, stereotactic body radiation therapy.