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

Table 1.

Trials testing radiotherapy in combination with PD-1/PD-L1 in advanced metastatic cancers that allowed only one irradiated lesion or did not mention the irradiated numbers.

NCT number Phase Tumor type RT regimen PD-1/PD-L1 inhibitors Treatment schedule timing Trial design (arms) Primary outcome Status
NCT03988647 II Metastatic Merkel cell carcinoma 9 Gy × 3f or 4–6 Gy × 5f Pembrolizumab RT will be given between the first and second cycles of immunotherapy Single group ORR Recruiting
NCT03220854 II Advanced solid tumors 6–12 Gy × 3–5f Humanized anti-PD-1 monoclonal antibody PD-1 inhibitor will be started after last SRT fraction (on same day) Single group Proportion of patients with improved disease control Active, not recruiting
NCT03548428 II Oligometastase in Sarcoma SBRT:3 to 5 fractions depending on tumor size Atezolizumab Not mentioned Arm A: SBRT+Atezolizumab
Arm B:SBRT
PFS Recruiting (62)
NCT02843165 II Advanced metastatic disease 9.5 Gy × 3 allowed reduction (6 Gy × 3 Minimum Dose) Anti-CTLA-4 and anti-PD-1/PD-L1 antibodies SBRT will be delivered within 1–21 days of the start of Cycle 1 of the CBI Arm A: CBI plus SBRT
Arm B: CBI
ORR Recruiting
NCT04166734 I/II Advanced malignant pleural mesothelioma 10 Gy × 3f Pembrolizumab Pembrolizumab will be given prior to SBRT Sequential assignment
Non-randomized
AE Not yet recruiting
NCT03436056 I/II Metastatic NSCLC 10 Gy × 3f
18 Gy × 3f
dosed at the maximum tolerated dose
Pembrolizumab Pembrolizumab will be given prior to SBRT Sequential assignment
Non-randomized
AE.To establish the recommended dose Active, not recruiting
NCT02992912 II Metastatic tumors (colorectal cancer, NSCLC, RCC, sarcoma) 15 Gy × 3f Atezolizumab Not mentioned Single Group PFS Recruiting
NCT03115801 II Metastatic genitourinary cancers 10 Gy × 3f Nivolumab
Atezolizumab
Pembrolizumab
PD-1/PD-L1 inhibitor is administered on the day of radiation (Day 1) Arm A:immunotherapy alone Arm B:Radiation and immunotherapy ORR Active, not recruiting
NCT02400814 I Stage IV NSCLC Total of five fractions MPDL3280A Arm A:concurrent
Arm B:induction cohort
Arm C:sequential cohort
Arm A:SBRT Beginning on day 1 of course 1
Arm B:SBRT Beginning on day 1 of course 3
Arm C:SBRT prior to anti-PD-L1
To determine best administration schedule of MPDL3280A and SBRT Active, not recruiting
NCT04098432 I/II Locally advanced unresectable pancreatic adenocarcinoma 8 Gy × 4f Nivolumab Nivolumab is given after SBRT Single Group AE Recruiting
NCT03509584 I Pretreated advanced stage non-small cell lung cancer 8 Gy × 3f Nivolumab Not mentioned Arm I:HFRT+ Nivolumab
Arm II: HFRT+ Nivolumab + ipilimumab
AE Recruiting
NCT04306926 II Advanced oligometastatic NSCLC Give according to the location of the lesion and clinical condition. TQB2450 SBRT 3 days before TQB2450 Single group PFS Not yet recruiting
NCT02599779 II TKI refractory metastatic kidney cancer (mRCC) patients Dose and duration dependent on body site Pembrolizumab Arm-A: SBRT will be given at the time of progression on pembrolizumab and pembrolizumab will be continued.
Arm B: SBRT will be given before the 2nd course of pembrolizumab and pembrolizumab will be continued.
Arm A: SBRT will be given at the time of progression on pembrolizumab and pembrolizumab will be continued.
Arm B: SBRT will be given before the 2nd course of pembrolizumab and pembrolizumab will be continued.
PFS Recruiting
NCT04547452 II Advanced metastatic HCC 7–10 Gy × 5–8f Sintilimab The first course of sintilimab will be given within 4–6 weeks after completion of SBRT. Arm A: Sintilimab and SBRT
Arm B:Sintilimab
PFS Recruiting
NCT03035890 I/II Metastatic NSCLC 8–15 Gy × 3f
6–10 Gy × 5f
Nivolumab
Pembrolizumab
Atezolizumab
Concurrent Single group ORR Active, not recruiting
NCT03122496 I Metastatic anaplastic thyroid cancer 9 Gy × 3 f Durvalumab RT is given within 2 weeks after the completion of cycle 1 of durvalumab and tremelimumab Single group OS Active, not recruiting
NCT03867175 III Metastatic lung cancer 3–10 treatments of SBRT Pembrolizumab Not mentioned Arm A:SBRT and Pembrolizumab
Arm B:Pembrolizumab
PFS Recruiting
NCT02826564 I Metastatic urothelial cancer SBRT Pembrolizumab Arm A:Sequential
Arm B:Concurrent
Arm A:SBRT prior to pembrolizumab
Arm B:SBRT concurrent with pembrolizumab
AE
DLT
Completed (63)
NCT03101475 II Colorectal cancer liver metastases 10 Gy × 3 f Durvalumab SBRT is started 8–14 days after first dose of immunotherapy Single group ORR Recruiting
NCT04167657 II Advanced NSCLC 6 Gy × 5f Sintilimab Sintilimab is started no later than 3 weeks after radiation. Single group ORR Recruiting
NCT04361162 II MSS pancreatic cancer Not mentioned Nivolumab Concurrent Single group ORR Recruiting

We searched “radiation and PD-1/PD-L1 inhibitors” in the clinicaltrials.gov database to identify studies with the following statuses: not yet recruiting, enrolling by invitation, recruiting, active, not recruiting, completed, and unknown status (Clinical Trial). A total of >60 trials were found. We identified the trials using radiotherapy with PD-1/PD-L1 inhibitors in advanced metastatic cancers (date of final query, 25 November 2020). Then we searched “radiation and immunotherapy” in the clinicaltrials.gov database as above. A total of >150 trials were found. We identified the studies of radiotherapy with PD-1/PD-L1 inhibitors in advanced metastatic cancers (date of final query, 25 November 2020). This list shows the trials that allowed only one irradiated lesion or did not mention the irradiated numbers. This list should not be considered comprehensive or exhaustive.

SABR, stereotactic ablative radiotherapy; PFS, progression free survival; CBI, checkpoint blockade immunotherapy; ORR, objective response rate; SBRT, stereotactic body radiotherapy; RCC, renal cell carcinoma; AE, adverse events; DLT, dose limiting toxicities; RT, raidotherapy; TKI, tyrosine kinase inhibitor; NSCLC, non-small-cell lung cancer; SCC, squamous cell carcinoma; HNSCC, head and neck squamous cell carcinoma; ICI, immune checkpoint inhibitor; HCC, hepatocellular carcinoma; OS, overall survival; ACC, adenoid cystic carcinoma; MSS, microsatellite stability.