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Table 5 Ongoing randomized clinical trial of testing combined therapy with PD-1/PD-L1

From: Reshaping the systemic tumor immune environment (STIE) and tumor immune microenvironment (TIME) to enhance immunotherapy efficacy in solid tumors

NCT number

Conditions

Experimental arms

Control arm

Phases

Enrollment

Primary outcome measures

NCT03924869

NSCLC

(Stage I/II)

SBRT + Pembrolizumab (Anti-PD-1)

SBRT + Placebo

Phase 3

530

EFS, OS

NCT03774732

NSCLC

(Stage IIIB/IIIC/IV)

3D-CRT/SABR + Pembrolizumab (Anti-PD-1) + Chemotherapy

Pembrolizumab (Anti-PD-1) + Chemotherapy

Phase 3

460

OS

NCT05298423

NSCLC

(Stage III)

Pembrolizumab (Anti-PD-1)/Vibostolimab Coformulation + Chemotherapy + Thoracic Radiotherapy

Chemotherapy + Thoracic Radiotherapy + Durvalumab (Anti-PD-L1)

Phase 3

784

PFS, OS

NCT03288870

NSCLC

(Stage IIIB/TNM Stage 4)

BCD-100 (Anti-PD-1) monotherapy

Docetaxel monotherapy

Phase 2

Phase 3

218

OS

NCT03150875

NSCLC

(Advanced/Metastatic)

IBI308 (Anti-PD-1)

Docetaxel

Phase 3

290

OS

NCT03922997

NSCLC

(Advanced/Metastatic)

Atezolizumab (Anti-PD-L1)

/

Phase 3

101

SAER

NCT02504372

NSCLC

(Stage IB/II-IIIA)

Pembrolizumab (Anti-PD-1)

Placebo

Phase 3

1177

DFS

NCT03285763

NSCLC

(Advanced/Metastatic)

Atezolizumab (Anti-PD-L1)

/

Phase 4

619

PAEs

NCT03949231

HCC

(Advanced)

PD1/PDL1 inhibitor hepatic artery infusion

PD1/PDL1 inhibitor vein infusion

Phase 3

200

OS

NCT04738487

NSCLC

Pembrolizumab (Anti-PD-1) + Vibostolimab (Anti-PD-1)

Pembrolizumab (Anti-PD-1)

Phase 3

1246

OS, PFS

NCT04331626

NSCLC

(Metastatic)

Nivolumab (Anti-PD-1) + Low-dose Gemcitabine

/

Phase 4

50

ORR

NCT04205812

NSCLC

(Metastatic)

Retifanlimab (Anti-PD-1) + Chemotherapy

Placebo + Chemotherapy

Phase 3

530

PFS, OS

NCT03594747

NSCLC

(Advanced)

Tislelizumab (Anti-PD-1) + Carboplatin + Paclitaxel

Tislelizumab (Anti-PD-1) + Carboplatin + Nab-Paclitaxel

Carboplatin + Paclitaxel

Phase 3

360

PFS

NCT03663205

NSCLC

(Advanced)

Tislelizumab (Anti-PD-1) + Platinum + Pemetrexed

Cisplatin/Carboplatin + Pemetrexed

Phase 3

334

PFS

NCT04702009

NSCLC

(Advanced)

Anti-PD-1/PD-L1 Antibody + Chemotherapy + Bronchoscopy-assisted Interventional Therapy

Anti-PD-1/PD-L1 Monoclonal Antibody + Chemotherapy

Phase 2

Phase 3

80

ORR

NCT03178552

NSCLC

(Unresectable/Advanced/Metastatic)

Cohort A: Alectinib 600 Milligrams (mg)

Cohort B: Dose Finding Phase (DFP) Alectinib

Cohort B: Dose Expansion Phase (DEP) Alectinib

Cohort C: Atezolizumab (Anti-PD-1)1200 mg

Cohort D: Entrectinib 600 Milligrams (mg)

Cohort E: Atezolizumab (Anti-PD-1), Vemurafenib, and Cobimetinib

Cohort F: Atezolizumab (Anti-PD-1), Bevacizumab, Carboplatin, and Pemetrexed

Cohort C: Pemetrexed, Cisplatin or Carboplatin

Cohort C: Gemcitabine, Cisplatin or Carboplatin

Phase 2

Phase 3

700

PFS, TIR, ORR

NCT03976375

NSCLC

(Metastatic)

Pembrolizumab (Anti-PD-1) + Lenvatinib (Anti-VEGF, Anti-FGFR, Anti-PDGFRα)

Lenvatinib (Anti-VEGF, Anti-FGFR, Anti-PDGFRα) Monotherapy

Docetaxel

Phase 3

405

OS, PFS

NCT04921358

NSCLC

(Advanced/Metastatic)

Tislelizumab (Anti-PD-1) + Sitravatinib (Anti-AXL, Anti-MER, Anti-VEGFR2, Anti-tPDGFR, Anti-KIT, Anti-RET, Anti-MET, Anti-DDR2, Anti-TRKA)

Docetaxel

Phase 3

420

OS, PFS

NCT03906071

NSCLC

(Advanced/Metastatic)

Nivolumab (Anti-PD-1) + Sitravatinib (Anti-AXL, Anti-MER, Anti-VEGFR2, Anti-tPDGFR, Anti-KIT, Anti-RET, Anti-MET, Anti-DDR2, Anti-TRKA)

Docetaxel

Phase 3

532

OS

NCT03829332

NSCLC

(Metastatic)

Pembrolizumab (Anti-PD-1) + Lenvatinib (Anti-VEGF, Anti-FGFR, Anti-PDGFRα)

Pembrolizumab (Anti-PD-1) + Placebo

Phase 3

623

OS, PFS

NCT04157985

NSCLC

HCC

(Advanced)

Discontinue Treatment with PD-1/PD-L1-1 inhibitor

Continue Treatment with PD-1/PD-L1 inhibitor

Phase 3

578

PFS

NCT04229355

HCC

(Unresectable/Advanced)

DEB-TACE + Sorafenib

DEB-TACE + Lenvatinib (Anti-VEGF, Anti-FGFR, Anti-PDGFRα)

DEB-TACE + PD-1 inhibitor

Phase 3

90

PFS

NCT03062358

HCC (Advanced)

Pembrolizumab (Anti-PD-1) + BSC

Placebo + BSC

Phase 3

454

OS

NCT05307926

HCC

(Recurrent)

PD-1 inhibitor

TACE

Phase 2

Phase 3

655

DFS, TEAEs

NCT03867084

HCC

Pembrolizumab (Anti-PD-1)

Placebo

Phase 3

950

RFS, OS

NCT04167293

HCC

(Early)

SBRT + Sintilimab (Anti-PD-1)

SBRT

Phase 2

Phase 3

116

PFS

NCT04709380

HCC (Advanced)

Radiotherapy + Toripalimab (Anti-PD-1)

Sorafenib

Phase 3

85

TPP

NCT03605706

HCC (Advanced)

SHR-1210(Anti-PD-1) + FOLFOX4

SHR-1210(Anti-PD-1) + Placebo

Phase 3

396

OS

NCT03713593

HCC

(Advanced)

Lenvatinib (Anti-VEGF, Anti-FGFR, Anti-PDGFRα) + Pembrolizumab (Anti-PD-1)

Lenvatinib (Anti-VEGF, Anti-FGFR, Anti-PDGFRα) + Placebo

Phase 3

750

PFS, OS

NCT03764293

HCC

(Unresectable/Advanced/Metastatic)

SHR-1210 (Anti-PD-1) + Apatinib (Anti-VEGFR2)

Sorafenib

Phase 3

543

OS, PFS

NCT05313282

HCC

(Advanced)

Hepatic Arterial Infusion combined with Apatinib (Anti-VEGFR-2) and Camrelizumab (Anti-PD-1)

Apatinib (Anti-VEGFR-2) + Camrelizumab (Anti-PD-1)

Phase 3

140

PFS

NCT03427827

NPC

(Advanced)

Camrelizumab (Anti-PD-1)

BSC

Phase 3

442

FFS

NCT04376866

NPC

(Recurrent)

CCRT + Toripalimab (Anti-PD-1)

CCRT

Phase 3

204

OS

NCT04778956

NPC

(Resectable/Recurrent)

Toripalimab (Anti-PD-1) + Salvage Surgery

Salvage Surgery

Phase 3

218

DFS

NCT04453813

NPC

(Recurrent)

Toripalimab (Anti-PD-1) + Concurrent Chemoradiotherapy

Concurrent Chemoradiotherapy

Phase 3

226

PFS

NCT03907826

NPC

(Recurrent)

PD-1 antibody + Chemoradiotherapy (IMRT + GP)

Chemoradiotherapy (IMRT + GP)

Phase 3

212

OS

NCT04907370

NPC

(Advanced)

Toripalimab (Anti-PD-1) + Induction Chemotherapy + IMRT

Toripalimab (Anti-PD-1) + Induction Chemotherapy + CCRT

Phase 3

520

FFS

NCT04557020

NPC

(Advanced)

PD-1 antibody + Chemotherapy + IMRT

Chemotherapy + IMRT

Phase 3

200

PFS

NCT03700476

NPC

(Advanced)

Sintilimab (Anti-PD-1) + Chemotherapy + IMRT

Chemotherapy + IMRT

Phase 3

425

FFS

NCT05097209

NPC

(Advanced)

Camrelizumab (Anti-PD-1) + Chemotherapy + IMRT

Chemotherapy + IMRT

Phase 3

458

PFS

NCT05340491

NPC

(Recurrent)

Chemotherapy + IMRT

Chemotherapy + IMRT

Phase 3

212

OS

NCT04453826

NPC

(Stage IVa, Stage II-III)

Camrelizumab (Anti-PD-1) + chemoradiotherapy arm

Chemoradiotherapy alone

Phase 3

388

PFS

NCT04890522

NPC

(Metastatic)

Triprilimab (Anti-PD-1) + Cisplatin + 5-Fluorouracil

Triprilimab (Anti-PD-1) + Cisplatin + Gemcitabine

Phase 2

Phase 3

622

OS, PFS

NCT05342792

NPC

(T4N + or TanyN2-3M0)

PD-1 antibody + Metronomic Capecitabine (Chemotherapy)

Metronomic Capecitabine (Chemotherapy)

Phase 3

556

FFS

NCT02611960

NPC

(Recurrent/Metastatic)

Pembrolizumab (Anti-PD-1)

Capecitabine + Gemcitabine + Docetaxel (Chemotherapy)

Phase 3

233

OS

  1. BSC best supportive car, DFS disease-free survival, EFS event-free survival, ORR objective response rate, OS overall survival, PAEs percentage of participants with adverse events, PFS progression-free survival, RFS recurrence-free survival, TEAEs incidence of treatment-emergent adverse events, TIR time in response, TTP time to progression, SAER serious adverse event incidence rates, SBRT stereotactic body radiotherapy, 3D-CRT three-dimensional conformal radiation therapy, IMRT intensity-modulated radiation therapy, CCRT concurrent chemoradiotherapy