Table 3.
NCT number | Phase | Tumor type | RT regimen | PD-1/PD-L1 inhibitors | Treatment schedule timing | Primary outcome | Status |
---|---|---|---|---|---|---|---|
NCT03474497 | I/II | Metastatic NSCLC, Melanoma, RCC, or HNSCC who have failed PD-1/ PD-L1 inhibitors | 8 Gy × 3f | Pembrolizumab | Radiotherapy will be delivered to the treatment lesion during the second cycle of therapy using an 8 Gy × 3 fractions palliative regimen.A total of four interleukin-2 treatments will be delivered into the treatment lesion by IT injection biweekly (at least 48 h apart) starting 24–96 h after the completion of radiotherapy and to be completed during the second on-trial cycle of Pembrolizumab. | Abscopal response rate | Recruiting |
NCT03224871 | Early Phase I | Metastatic NSCLC | 8 Gy × 3f | Nivolumab | Nivolumab will be started on week 1 day 1, concurrent with radiotherapy | DLT | Completed |
NCT03958383 | I/II | Melanoma | Palliative radiation therapy | Nivolumab | Phase IA: Participants receive hu14.18-IL2 fusion protein IT. Phase IB: Participants undergo palliative RT and hu14.18-IL2 fusion protein IT as in phase IA. Phase IC: Participants undergo palliative RT, receive nivolumab, and hu14.18-IL2 fusion protein IT as in phase IA. Phase ID: Participants undergo palliative RT, receive nivolumab in combination with ipilimumab, and hu14.18-IL2 fusion protein IT as in phase IA. |
AE MTD MAD |
Recruiting |
NCT04106180 | II | Advanced NSCLC | 8 Gy × 3f | Sintilimab | SBRT combined sintilimab and GM-CSF | ORR | Recruiting |
ChiCTR1900026175 | I/II | Metastatic solid tumor | 8 Gy × 3f | PD-1/PD-L1 inhibitors | SBRT combined PD-1/PD-L1 inhibitors and GM-CSF | Safety PFS Incidence of abscopal effects |
Recruiting |
ChiCTR2000035817 | I/II | Advanced liver cancer | Not mentioned | Carrelizumab | SBRT combined PD-1/PD-L1 inhibitors and GM-CSF | PFS | Recruiting |
We searched “radiation and IL-2” in the clinicaltrials.gov database to identify studies, and 18 trials were found. Data were obtained searching “SBRT and IL-2” in the clinicaltrials.gov database resulting in 4 trials, where 3 trials were on combining radiotherapy with PD-1/PD-L1 inhibitors and IL-2 (date of final query, 25 November 2020). Then we searched “IL-2” in www.chictr.org.cn database to identify studies; 17 trials were identified; no study met our requirements. Then we searched “radiation and GM-CSF” in the clinicaltrials.gov database. Thirty-seven trials were identified. Data were obtained searching “SBRT and IL-2” in the clinicaltrials.gov database to identify studies, and 5 trials were detected. We identified one study on radiotherapy with PD-1/PD-L1 inhibitors in advanced metastatic cancers (date of final query, 25 November 2020). Then we searched “GM-CSF” in www.chictr.org.cn database to identify studies; 10 trials were identified, where 2 studies were on combining radiotherapy with PD-1/PD-L1 inhibitors and GM-CSF. This list should not be considered comprehensive or exhaustive.
HNSCC, head and neck squamous cell carcinoma; NSCLC, non-small-cell lung cancer; RCC, renal cell carcinoma; MTD, maximum tolerated dose; MAD, maximum administered dose; AE, adverse events; DLT, dose limiting toxicities; SBRT, stereotactic body radiotherapy; ORR, objective response rate; PFS, progression free survival; IT, intratumorally.