Table 5 Clinical trials of immunotherapy combined with radiotherapy

From: Cold and hot tumors: from molecular mechanisms to targeted therapy

Phase

ICIs Combination Therapy (immune checkpoint)

Doses

[n.treatment]

OS

PFS

Disease

Trial

Status

Ref.

III

Durvalumab (PD-L1) + Chemoradiation therapy

Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy. durvalumab intravenously, at a dose of 10 mg per kilogram of body weight

[n = 473]

47.5 m

16.9 m

NSCLC

NCT02125461

Completed

758,759

 

Chemoradiation Therapy

Randomization occurred 1 to 42 days after the patients had received chemoradiotherapy.placebo every 2 weeks for up to 12 months

[n = 236]

29.1 m

5.6 m

    

III

Ipilimumab (CTLA-4) + RT

bone-directed radiotherapy (8 Gy in one fraction) followed by ipilimumab 10 mg/kg every 3 weeks for up to four doses

[n = 399]

7.9% (5-year OS rate)

/

Prostate cancer

NCT00861614

Completed

760

 

RT

bone-directed radiotherapy (8 Gy in one fraction) followed by either placebo every 3 weeks for up to four doses

[n = 400]

2.7% (5-year OS rate)

/

    

II

Pembrolizumab (PD-1) + SBR

Pembrolizumab (200 mg/kg every 3 weeks) after radiotherapy (3 doses of 8 Gy) (experimental arm)

[n = 36]

15.9 m

6.6 m

NSCLC

NCT02492568

Completed

761

 

Pembrolizumab

Pembrolizumab (200 mg/kg every 3 weeks)

[n = 40]

7.6 m

1.9 m

    

II

Pembrolizumab (PD-1) + SBRT + Trametinib(MEK)

SBRT with doses ranging from 60-65 Gy in five fractions, intravenous pembrolizumab 200 mg once every 3 weeks, and oral trametinib (2 mg) once daily

[n = 29]

13.6 m

7.9 m

Pancreatic cancer

NCT02704156

Active, not recruiting

762

 

SBRT + Gemcitabine

SBRT (same regimen) and intravenous gemcitabine (1000 mg/m2) on day 1 and 8 of a 21-day cycle for eight cycles

[n = 34]

12.4 m

4.3 m

    

II

Sipuleucel-T + RT

sipuleucel-T alone (Arm A) or sipuleucel-T initiated 1 week after completing sensitizing RT to single metastatic site (Arm B). RT was delivered at 300 cGy/day to 3000 cGy total.

[n = 25]

/

3.65 m

Prostate cancer

NCT01807065

Completed

763

 

Sipuleucel-T

sipuleucel-T alone (Arm A) or sipuleucel-T initiated 1 week after completing sensitizing RT to single metastatic site (Arm B). RT was delivered at 300 cGy/day to 3000 cGy total.

[n = 24]

/

2.46 m