Table 6 Clinical trials of immunotherapy combined with chemotherapy

III

Pembrolizumab (PD-1) + Chemotherapy

pembrolizumab (200 mg) plus chemotherapy (cisplatin 80 mg/m²/d on day 1 plus fluorouracil 800 mg/m²/d on days 1 to 5 or capecitabine 1000 mg/m² twice daily) every 3 weeks

[n = 257]

PD-L1 score ≥1 population:16.5 m;PD-L1 score ≥10 population:17.5 m

PD-L1 score ≥1 population:6.9 m

G/GEJ cancer

NCT02494583

Completed

^771,772

Chemotherapy

chemotherapy (cisplatin 80 mg/m²/d on day 1 plus fluorouracil 800 mg/m²/d on days 1 to 5 or capecitabine 1000 mg/m² twice daily) every 3 weeks

[n = 250]

PD-L1 score ≥1 population:13.8 m;PD-L1 score ≥10 population:14.8 m

PD-L1 score ≥1 population:6.4 m

III

Pembrolizumab (PD-1) + Chemotherapy

pembrolizumab (200 mg) every 3 weeks plus chemotherapy (nab-paclitaxel; paclitaxel; or gemcitabine plus carboplatin)

[n = 566]

PD-L1 score ≥1 population:17.6 m;PD-L1 score ≥10 population:23.0 m

/

TNBC

NCT02819518

Completed

^785,786

Chemotherapy

placebo plus chemotherapy

[n = 281]

PD-L1 score ≥1 population:16.0 m;PD-L1 score ≥10 population:16.1 m

/

III

Pembrolizumab (PD-1) + Chemotherapy

pembrolizumab (200 mg) every 3 weeks for a maximum of 35 cycles plus intravenous chemotherapy (gemcitabine [1000 mg/m²] on days 1 and 8 and investigator’s choice of cisplatin [70 mg/m²] or carboplatin [area under the curve 5] on day 1 of every 3-week cycle) for a maximum of six cycles

[n = 351]

17.0 m

8.3 m

Urothelial cancer

NCT02853305

Completed

⁷⁷⁶

Chemotherapy

chemotherapy (gemcitabine [1000 mg/m²] on days 1 and 8 and investigator’s choice of cisplatin [70 mg/m²] or carboplatin [area under the curve 5] on day 1 of every 3-week cycle) for a maximum of six cycles

[n = 352]

14.3 m

7.1 m

III

Pembrolizumab (PD-1) + Chemotherapy

pemetrexed and a platinum-based drug plus 200 mg of pembrolizumab every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy

[n = 410]

5-year OS rates:19.4%

/

NsqNSCLC

NCT02578680

Completed

^777,778

Chemotherapy

pemetrexed and a platinum-based drug plus placebo every 3 weeks for 4 cycles, followed by pembrolizumab or placebo for up to a total of 35 cycles plus pemetrexed maintenance therapy

[n = 206]

5-year OS rates:11.3%

/

III

Pembrolizumab (PD-1) + Chemotherapy

200 mg of pembrolizumab for up to 35 cycles; all the patients also received carboplatin and either paclitaxel for the first 4 cycles.

[n = 278]

5-year OS rates:18.4%

/

SqNSCLC

NCT02775435

Completed

^779,780

Chemotherapy

saline placebo for up to 35 cycles; all the patients also received carboplatin and either paclitaxel for the first 4 cycles.

[n = 281]

5-year OS rates:9.7%

/

III

Pembrolizumab (PD-1) + Chemotherapy

pembrolizumab 200 mg intravenously every 3 weeks for up to 35 cycles. All participants received investigator’s choice of fluorouracil (intravenous, 800 mg/m² per day) administered continuously on days 1-5 of each 3-week cycle plus cisplatin (intravenous, 80 mg/m²) administered on day 1 of each 3-week cycle or capecitabine (oral, 1000 mg/m²) administered twice daily on days 1-14 of each 3-week cycle plus oxaliplatin (intravenous, 130 mg/m²) administered on day 1 of each 3-week cycle.

[n = 790]

PD-L1 score ≥1 population:13.0 m;PD-L1 score ≥10 population:15.7 m

/

HER2-negative advanced gastric cancer

NCT03675737

Active, not recruiting

⁷⁹⁰

Chemotherapy

placebo 200 mg, administered intravenously every 3 weeks for up to 35 cycles. All participants received investigator’s choice of fluorouracil (intravenous, 800 mg/m² per day) administered continuously on days 1-5 of each 3-week cycle plus cisplatin (intravenous, 80 mg/m²) administered on day 1 of each 3-week cycle or capecitabine (oral, 1000 mg/m²) administered twice daily on days 1-14 of each 3-week cycle plus oxaliplatin (intravenous, 130 mg/m²) administered on day 1 of each 3-week cycle.

[n = 789]

PD-L1 score ≥1 population:11.4 m;PD-L1 score ≥10 population:11.8 m

/

II

Pembrolizumab (PD-1) + Chemotherapy

4 cycles of pembrolizumab 200 mg plus carboplatin area under curve 5 mg/mL per min and pemetrexed 500 mg/m² every 3 weeks followed by pembrolizumab for 24 months and indefinite pemetrexed maintenance therapy or to 4 cycles of carboplatin and pemetrexed alone followed by indefinite pemetrexed maintenance therapy

[n = 60]

/

24.5 m

NSCLC

NCT02039674

Completed

⁷⁸¹

Chemotherapy

carboplatin area under curve 5 mg/mL per min and pemetrexed 500 mg/m² every 3 weeks followed by pembrolizumab for 24 months and indefinite pemetrexed maintenance therapy or to 4 cycles of carboplatin and pemetrexed alone followed by indefinite pemetrexed maintenance therapy

[n = 63]

/

9.9 m

III

Pembrolizumab (PD-1) + Neoadjuvant chemotherapy

neoadjuvant therapy with four cycles of pembrolizumab (at a dose of 200 mg) every 3 weeks plus paclitaxel and carboplatin

[n = 784]

/

/

TNBC

NCT03036488

Active, not recruiting

⁷⁸⁷

Neoadjuvant Chemotherapy

placebo every 3 weeks plus paclitaxel and carboplatin

[n = 390]

/

/

III

Camrelizumab (PD-1) + Chemotherapy

camrelizumab (200 mg), combined with up to 6 cycles of paclitaxel (175 mg/m²) and cisplatin (75 mg/m²).

[n = 298]

15.3 m

6.9 m

ESCC

NCT03691090

Completed

⁷⁹¹

Chemotherapy

placebo combined with up to 6 cycles of paclitaxel (175 mg/m²) and cisplatin (75 mg/m²).

[n = 298]

12.0 m

5.6 m

II

Cemiplimab (PD-1) + Chemotherapy

cemiplimab 350 mg every 3 weeks in combination with four cycles of chemotherapy

[n = 312]

21.1 m

8.2 m

Advanced NSCLC without EGFR, ALK, or ROS1 aberrations

NCT03409614

Active, not recruiting

^782,783

Chemotherapy

placebo every 3 weeks in combination with four cycles of chemotherapy

[n = 154]

12.9 m

5.5 m

III

Nivolumab (PD-1) + Chemotherapy

nivolumab (360 mg every 3 weeks or 240 mg every 2 weeks) plus chemotherapy (capecitabine and oxaliplatin every 3 weeks or leucovorin, fluorouracil, and oxaliplatin every 2 weeks)

[n = 789]

36-month OS rates:21%

36-month PFS rates:13%

G/GEJ cancer

NCT02872116

Active, not recruiting

^773,774

Chemotherapy

chemotherapy (capecitabine and oxaliplatin every 3 weeks or leucovorin, fluorouracil, and oxaliplatin every 2 weeks)

[n = 792]

36-month OS rates:10%

36-month PFS rates:8%

III

Serplulimab (PD-1) + Chemotherapy

serplulimab (4.5 mg/kg) both in combination with nab-paclitaxel and carboplatin, intravenously in 3-week cycles

[358]

8.3 m

22.7 m

NSCLC

NCT04033354

Active, not recruiting

⁷⁸⁴

Serplulimab (PD-1)

placebo both in combination with nab-paclitaxel and carboplatin, intravenously in 3-week cycles

[179]

5.7 m

18.2 m

II

Toripalimab (PD-1) + Chemotherapy

three preoperative and five postoperative 3-week cycles of SOX/XELOX, followed by toripalimab monotherapy for up to 6 months

[n = 54]

/

/

G/GEJ cancer

NCT04250948

Active, not recruiting

⁷⁷⁵

Chemotherapy

three preoperative and five postoperative 3-week cycles of SOX/XELOX

[n = 54]

/

/

III

Tislelizumab + Chemotherapy

tislelizumab (200 mg) intravenously every 3 weeks on day 1, together with an investigator chosen chemotherapy doublet

[n = 326]

17.2 m

/

OSCC

NCT03783442

Active, not recruiting

⁷⁹²

Chemotherapy

placebo intravenously every 3 weeks on day 1, together with an investigator chosen chemotherapy doublet

[n = 323]

13.6 m

/

Ib

Tislelizumab (PD-1) + Sitravatinib

sitravatinib (120 mg) orally one time per day plus tislelizumab 200 mg intravenously every 3 weeks

[n = 25]

/

6.7 m

Melanoma

NCT03666143

Completed

⁷⁶⁹

III

Atezolizumab (PD-L1) + Nab-paclitaxel

atezolizumab at a dose of 840 mg, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-surface area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle

[n = 451]

25 m

7.2 m

TNBC

NCT02425891

Completed

^788,789

Nab-paclitaxel

placebo, administered intravenously, on days 1 and 15 and received nab-paclitaxel at a dose of 100 mg per square meter of body-surface area, administered intravenously, on days 1, 8, and 15 of every 28-day cycle

[n = 451]

18 m

5.5 m

III

Ipilimumab (CTLA-4) + Dacarbazine

ipilimumab (10 mg per kilogram) plus dacarbazine (850 mg per square meter of body-surface area), given at weeks 1, 4, 7, and 10, followed by dacarbazine alone every 3 weeks through week 22

[n = 250]

11.2 m

/

Melanoma

NCT00324155

Completed

⁷⁷⁰

Dacarbazine

dacarbazine (850 mg per square meter) plus placebo, given at weeks 1, 4, 7, and 10, followed by dacarbazine alone every 3 weeks through week 22

[n = 252]

9.1 m

/