Table 1.
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.