Table 5.
Selected ongoing clinical trials investigating the combination of Immunotherapy and RT.
| NCT identifier | Study phase | Number of patients estimated | Study population | Standard arm | Experimental arm | Primary endpoint |
|---|---|---|---|---|---|---|
| NCT04047602 (Indiana University Health Hospital Recruiting Indianapolis) | NA | 42 | BMs (1-10) from NSCLC | – | Reduced Dose SRS based on the brain tumor size concurrently with standard of care IT | Symptomatic RN rate |
| NCT03458455 (Oslo University Hospital Oslo, Norway) | NA (Cohort, Prospective) | 200 | BMs from NSCLC, BMs from malignant melanoma | – | A. : BMs from NSCLC receiving SRS to selected lesionsB. : BMs from malignant melanoma receiving SRS to selected lesionsC. : BMs from NSCLC receiving SRS to selected lesions + nivolumab or pembrolizumabD. : BMs from malignant melanoma receiving SRS to selected lesions + ipilimumab, nivolumab or pembrolizumabE. : BMs from NSCLC receiving SRS to selected lesions + EGFR inhibitors | Treatment Response |
| NCT04787185 | NA (Multicenter, Prospective Observational Study) | 50 | BMs from NSCLC | – | SRT + IT | Evaluation of toxicity |
| NCT02858869 (Emory University/Winship Cancer Institute Atlanta) | I | 30 | Stage IV NSCLC and melanoma | – | A. : Pembrolizumab, SRS 6 Gy x 5 fx, ClosedB. : Pembrolizumab, SRS 9 Gy x 3 fxC. : Pembrolizumab, SRS 18-21 Gy | Safety of 3 different SRS radiation arms in combination with pembrolizumab |
| NCT02696993 (M D Anderson Cancer Center Houston) | II | 88 | Stage IV NSCLC | – | A. : Nivolumab, SRSB. : Nivolumab, WBRTC. : Nivolumab, Ipilimumab, SRSD. : Nivolumab, Ipilimumab, WBRT | RP2D of Nivoluma, RP2D of Nivolumab + Ipilimumab, RP2D of Nivolumab + SRS/WBRT, RP2D of Nivolumab + Ipilimumab and SRS/WBRT |
| NCT02978404 (Centre Hospitalier de l’Université de Montréal (CHUM) Montreal) | II | 60 (26 actual enrollment) | Stage IV NSCLC, SCLC, Melanoma OR ccRCC | – | SRS and Nivolumab | iPFS |
| NCT04427228 (University Of Chicago Chicago) | II | 74 | BMs from different histology in patients treated with immunotherapy (PD-1/PD-L1 and/or CTLA-4 inhibitor(s)) within the past 6 months or plan on receiving immunotherapy within the next 1 month. | SRS (20 or 18 Gy) | Radiosurgery Three Treatments (27 Gy/3fx) | Multi-Fraction SRS superiority compared to single fraction SRS |
| NCT04650490 (Duke Cancer Center Durham) | II | 80 | BMs (1-15) from NSCLC | – | A. : Immediate SRS followed by ITB. : Immediate IT followed by SRS | iPFS |
| NCT04889066 (University of Texas Southwestern Medical Center) | II | 40 | BMs from NSCLC | Durvalumab + standard SRT | Durvalumab + PULSAR (Personalised Ultra fractionated Stereotactic Adaptive Radiotherapy) | Intercranial clinical benefit |
| NCT04291092 | II | 20 | BMs from NSCLC | – | SHR-1210 + WBRT/SRS | PFS, ORR |
| NCT04180501 (Union hospital Wuhan, Hubei, China) | II | 25 | BMs from advanced NSCLC | – | SRS sequential sindilimab | iPFS |
| NCT04768075 (Guangdong Association of Clinical Trials) | III | 200 | BMs (≥ 3) from driven gene-negative NSCLC | Placebo combined with chemotherapy (pemetrexed or paclitaxel or Nab-paclitaxel + cisplatin or carboplatin) +/- SRS/WBRT | Camrelizumab combined with chemotherapy (pemetrexed or paclitaxel or Nab-paclitaxel + cisplatin or carboplatin) +/- SRS/WBRT |
iPFS |
NA, not applicable; fr, fractions; WBRT, Whole Brain Radiation Therapy; SRS, Radiosurgery; SRT, fractionated stereotactic radiotherapy; EGFR, Epidermal Growth Factor Receptor; iPFS, Progression Free Survival; ORR, Overall Response Rate; RP2D, Recommended Phase 2 Dose; IT, Immunotherapy; RN, Radionecrosis.