Table 5.
Clinical trials of immunotherapy combined with radiotherapy
| Phase | ICIs Combination Therapy (immune checkpoint) | Doses | [n.treatment] | OS | PFS | Disease | Trial | Status | Ref. |
|---|---|---|---|---|---|---|---|---|---|
| III | Durvalumab (PD-L1) + Chemoradiation therapy | Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy. durvalumab intravenously, at a dose of 10 mg per kilogram of body weight | [n = 473] | 47.5 m | 16.9 m | NSCLC | NCT02125461 | Completed | 758,759 |
| Chemoradiation Therapy | Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy.placebo every 2 weeks for up to 12 months | [n = 236] | 29.1 m | 5.6 m | |||||
| III | Ipilimumab (CTLA-4) + RT | bone-directed radiotherapy (8 Gy in one fraction) followed by ipilimumab 10 mg/kg every 3 weeks for up to four doses | [n = 399] | 7.9% (5-year OS rate) | / | Prostate cancer | NCT00861614 | Completed | 760 |
| RT | bone-directed radiotherapy (8 Gy in one fraction) followed by either placebo every 3 weeks for up to four doses | [n = 400] | 2.7% (5-year OS rate) | / | |||||
| II | Pembrolizumab (PD-1) + SBR | Pembrolizumab (200 mg/kg every 3 weeks) after radiotherapy (3 doses of 8 Gy) (experimental arm) | [n = 36] | 15.9 m | 6.6 m | NSCLC | NCT02492568 | Completed | 761 |
| Pembrolizumab | Pembrolizumab (200 mg/kg every 3 weeks) | [n = 40] | 7.6 m | 1.9 m | |||||
| II | Pembrolizumab (PD-1) + SBRT + Trametinib(MEK) | SBRT with doses ranging from 60-65 Gy in five fractions, intravenous pembrolizumab 200 mg once every 3 weeks, and oral trametinib (2 mg) once daily | [n = 29] | 13.6 m | 7.9 m | Pancreatic cancer | NCT02704156 | Active, not recruiting | 762 |
| SBRT + Gemcitabine | SBRT (same regimen) and intravenous gemcitabine (1000 mg/m2) on day 1 and 8 of a 21-day cycle for eight cycles | [n = 34] | 12.4 m | 4.3 m | |||||
| II | Sipuleucel-T + RT | sipuleucel-T alone (Arm A) or sipuleucel-T initiated 1 week after completing sensitizing RT to single metastatic site (Arm B). RT was delivered at 300 cGy/day to 3000 cGy total. | [n = 25] | / | 3.65 m | Prostate cancer | NCT01807065 | Completed | 763 |
| Sipuleucel-T | sipuleucel-T alone (Arm A) or sipuleucel-T initiated 1 week after completing sensitizing RT to single metastatic site (Arm B). RT was delivered at 300 cGy/day to 3000 cGy total. | [n = 24] | / | 2.46 m |