Table 7 Clinical trials of immunotherapy combined with target therapy

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.

I/II

Pembrolizumab (PD-1) + Enfortumab vedotin (Nectin-4)

vedotin (1.25 mg/kg) once daily on days 1 and 8 and pembrolizumab (200 mg) (day 1) intravenously once daily in 3-week cycles.

[n = 45]

/

12.3 m

Urothelial cancer

NCT03288545

Active, not recruiting

848

I/II

Pembrolizumab (PD-1) + Niraparib (PARP1/2)

niraparib (200) mg of oral once daily and pembrolizumab (200 mg) of intravenous on day 1 of each 21-day cycle.

[n = 62]

/

/

Ovarian carcinoma

NCT02657889

Completed

843

III

Atezolizumab (PD-L1) + Vemurafenib (B-RAF) + Cobimetinib(MEK1)

atezolizumab (840 mg) intravenous day 1 and 15, twicedaily vemurafenib (720 mg), and once-daily cobimetinib (60 mg) 21 days on–7 days off.

[n = 256]

/

39 m

Melanoma

NCT02908672

Active, not recruiting

835,836

 

Vemurafenib (B-RAF) + Cobimetinib (MEK1)

placebo intravenous day 1 and 15, twicedaily vemurafenib (720 mg), and once-daily cobimetinib (60 mg) 21 days on–7 days off.

[n = 258]

/

25.8 m

    

II

Atezolizumab (PD-L1) + Cobimetinib (MEK1) + Chemotherapy

Cobimetinib (60 mg QD) on days 1–21 of each 28-day cycle; paclitaxel (80 mg/m2 QW); nab-paclitaxel (100 mg/m2 QW); atezolizumab (840 mg Q2W).

[n = 32]

11.0 m

3.8 m

TNBC

NCT02322814

Terminated

837

 

Cobimetinib (MEK1) + Chemotherapy

Cobimetinib (60 mg QD) on days 1–21 of each 28-day cycle; paclitaxel (80 mg/m2 QW); nab-paclitaxel (100 mg/m2 QW).

[n = 47]

16. m

5.4 m

    

I/II

Durvalumab (PD-L1) + Olaparib (PARP1/2)

olaparib (300 mg) in tablet form orally twice daily for 4 weeks and thereafter a combination of olaparib (300 mg) twice daily and durvalumab (1.5 g) via intravenous infusion every 4 weeks until disease progression

[n = 34]

21.5 m

8.2 m

Breast cancer

NCT02734004

Active, not recruiting

841

II

Durvalumab (PD-L1) + Olaparib (PARP1/2)

Cediranib was taken intermittently 5 days on/2 days off at (15 or 20 mg) (dose levels 1 and 2, respectively) with durvalumab (1500 mg) IV every 4 weeks, and olaparib tablets (300 mg) twice daily.

[n = 35]

/

3.4 m

Ovarian cancer

NCT02484404

Recruiting

842

III

IL-2 + Dinutuximab beta (GD2)

dinutuximab beta (20 mg/m2 per day as an 8 h infusion for 5 consecutive days)

[n = 206]

62% (5-year OS rate)

57% (5-year EFS rate)

NB

NCT01704716

Recruiting

838

 

Dinutuximab beta (GD2)

dinutuximab beta plus subcutaneous IL-2 (6×106 IU/m2 per day on days 1-5 and days 8-12 of each cycle)

[n = 200]

63% (5-year OS rate)

53% (5-year EFS rate)

    
  1. NSCLC non-small cell lung cancer, SCLC small cell lung cancer, NB neuroblastoma, TNBC triple-negative breast cancer, AML acute myeloid leukemia, OCSC oral cavity squamous cell carcinoma, CRC colorectal cancer, ESCC esophageal squamous cell carcinoma, MPM malignant pleural mesothelioma, HNSCC head and neck squamous cell carcinoma, RCC renal cell carcinoma, HCC hepatocellular carcinoma, PDAC pancreatic ductal adenocarcinoma, mUC metastatic urothelial carcinoma, G/GEJ cancer gastroesophageal junction cancer