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. 2021 Mar 30;11:638873. doi: 10.3389/fonc.2021.638873

Table 3.

Trials testing radiotherapy in combination with PD-1/PD-L1 and cytokines (IL-2 or GM-CSF).

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.