Table 3.
Ongoing clinical trials of ICIs in R/M NPC.
| Trial identifier | Treatment | Phase | Patient selection | Estimated enrollment | Primary endpoint | Completion date | |
|---|---|---|---|---|---|---|---|
| ICI monotherapy | |||||||
| NCT02605967 | PDR001 a | Phase II | R/M NPC at least failing to first-line chemotherapy | 122 | PFS | February 2021 | |
| NCT03866967 | AK105 a | Phase II | R/M NPC at least failing to first-line chemotherapy | 153 | ORR | December 2020 | |
| NCT02875613 | Avelumab | Phase II | EBV-related R/M NPC at least failing to first-line therapy | 6 | ORR | April 2019 | |
| NCT04221516 | Camrelizumab a | Phase II | After completion of radiotherapy for oligometastatic NPC | 52 | PFS | February 2023 | |
| NCT04220307 | AK-104 | Phase II | R/M NPC as third-line setting | 140 | ORR | November 2021 | |
| NCT03558191 | SHR-1210 | Phase II | R/M NPC as third-line setting | 155 | ORR | 30 December 2020 | |
| NCT05198531 | TQB2858 | Phase Ib | R/M NPC failed platinum-based chemotherapy and ICIs; untreated NPC | 90 | AEs | October 2022 | |
| NCT05222009 | G-CSF + PD-(L)1 antibody | Phase I | Received prior treatment with platinum agents and PD-(L)1 inhibitors in R/M NPC | 25 | ORR | November 2022 | |
| NCT03752398 | XmAb23104 | Phase I | Advanced solid tumor including NPC failure at standard therapy | 234 | AEs | July 2023 | |
| NCT04272034 | INCB099318 | Phase I | Advanced solid tumor including NPC failure at standard therapy | 100 | AEs | December 2022 | |
| ICI combination therapy | |||||||
| Combine with ICIs | NCT03849469 | XmAb22841 + pembrolizumab a | Phase I | Advanced solid tumor including NPC | 242 | Safety; AEs | November 2025 |
| NCT04945421 | Sintilimab a + IBI310 | Phase I/II | Anti-PD-1/PD-L1 resistance R/M NPC | 121 | ORR | March 2024 | |
| NCT03097939 | Ipilimumab + nivolumab a | Phase II | Advanced EBV-driven NPC | 40 | ORR | November 2021 | |
| NCT04282070 | SHR-1701 | Phase I | R/M NPC failing to first-line chemotherapy; failure at anti-PD-1 immunotherapy | 91 | AEs | December 2022 | |
| NCT05020925 | SHR-1701 + famitinib | Phase I/II | R/M NPC failing to prior platinum therapy | 30 | ORR | February 2024 | |
| NCT02834013 | Nivolumab and ipilimumab | Phase II | Rare cancer including NPC | 818 | ORR | October 2023 | |
| NCT03517488 | XmAb20717 | Phase I | Advanced solid tumors including NPC | 154 | AEs | April 2021 | |
| Combine with CT | NCT02611960 | Pembrolizumab a + GTX | Phase III | R/M NPC failing to prior platinum therapy | 233 | OS | May 2022 |
| NCT04458909 | Nivolumab a + GCP | Phase III | R/M NPC as first-line treatment | 316 | OS | May 2028 | |
| NCT03924986 | Tislelizumab a + GP | Phase III | R/M NPC as first-line treatment | 256 | PFS | June 2022 | |
| NCT04890522 | Toripalimab a + GFP | Phase II/III | Primary metastatic NPC as first-line treatment | 622 | PFS; OS; SAE | December 2028 | |
| NCT04944914 | Camrelizumab a + SBRT | Phase III | Oligometastatic NPC | 188 | PFS | June 2026 | |
| NCT04974398 | AK 105 a + GP | Phase III | R/M NPC as first-line treatment | 278 | PFS | July 2023 | |
| NCT05166577 | Nanatinostat + valganciclovir + pembrolizumab | Phase Ib/II | R/M NPC with EBV positive as second-or third-line setting | 88 | DLT; ORR | May 2024 | |
| Combine with RT | NCT03925090 | Toripalimab + CCRT | Phase II | Stage III–IVa and EBV DNA ⩾ 1500 copies/ml | 138 | PFS | October 2023 |
| Combine with CT + RT | NCT04421469 | Toripalimab a + gemcitabine + RT | Phase II | Multiple metastatic NPC | 39 | PFS | June 2023 |
| NCT04398056 | CT + subsequent RT + toripalimab | Phase II | De novo metastatic NPC | 22 | ORR | April 2021 | |
| Targeted therapy | NCT04825990 | Pembrolizumab a + olaparib | Phase II | Platinum-resistant R/M NPC | 30 | ORR | June 2027 |
| NCT04562441 | Avelumab + axitinib | Phase II | R/M NPC at least failing to first-line chemotherapy | 43 | ORR | December 2027 | |
| NCT04586088 | Camrelizumab a + apatinib | Phase II | R/M NPC failing to first-line chemotherapy | 57 | ORR | May 2022 | |
| NCT04872582 | Sintilimab a + bevacizumab | Phase II | R/M NPC failing to first-line chemotherapy | 33 | ORR | May 2022 | |
| NCT04350190 | PD-1 inhibitor + apatinib | Phase II | R/M NPC failing to one comprehensive treatment | 25 | ORR | May 2022 | |
| NCT04548271 | Camrelizumab a + apatinib | Phase II | PD-1 antagonists resistant R/M NPC failing to first-line therapy | 25 | ORR | October 2023 | |
| NCT04547088 | Camrelizumab a + Apatinib | Phase II | R/M NPC failing to first-line chemotherapy | 27 | ORR | October 2023 | |
| NCT03813394 | Pembrolizumab a + bevacizumab | Phase Ib/II | EBV-positive NPC failing to first-line chemotherapy | 48 | ORR; PFS | March 2024 | |
| NCT04736810 | AK105 a + GP + anlotinib | Phase II | R/M NPC as first-line treatment | 90 | ORR | June 2023 | |
| NCT04073784 | Toripalimab a + gemcitabine + apatinib | Phase I | R/M NPC as first-line treatment | 20 | AEs | June 2021 | |
| NCT05162872 | Niraparib and sintilimab | Phase II | R/M NPC failing to first-line therapy | 99 | ORR | October 2023 | |
| NCT03074513 | Atezolizumab and bevacizumab | Phase II | Rare solid tumors including NPC | 137 | ORR | December 2022 | |
AC, adjuvant chemotherapy; AE, adverse event; CCRT, concurrent chemoradiothrapy; CT, chemotherapy; DLTS, incidence of dose-limiting toxicities; DNA, deoxyribonucleic acid; EBV, Epstein–Barr virus; GCP, Cisplatin + Gemcitabine + Carboplatin; GFP, Cisplatin + Gemcitabine + 5-Fluorouracil; GP, Cisplatin + Gemcitabine; GTX, Capecitabine + Gemcitabine + Docetaxel; IC, induction chemotherapy; ICIs, immune checkpoint inhibitors; NPC, nasopharyngeal carcinoma; ORR, objective response rate; OS, overall survival; PD-1, programmed death-1; PD-L1, programmed death ligand-1; PFS, progression-free survival; R/M, recurrence and/or metastatic; RT, radiotherapy; SAE, serious adverse event; SBRT, stereotactic body radiation therapy.
Nanatinostat: a selective class I HDAC inhibitor which induces EBV early lytic phase protein generation, activating (val) ganciclovir to its cytotoxic form.
Represents anti-PD-1 antibody; avelumab: anti-PD-L1 antibody; INCB099318: an oral, small molecule that targets PD-L1; XmAb22841: CTLA-4/LAG-3 bispecific antibody; IBI310: anti-CTLA-4 antibody; AK-104: PD-1/CTLA-4 bispecific antibody; ipilimumab: anti-CTLA-4 antibody; SHR-1701: a bifunctional fusion protein targeting PD-L1 and TGF-β; TQB2858 injection: a bifunctional fusion protein against PD-L1 and transforming growth factor-β; XmAb23104: a bispecific antibody targeting PD-1 and ICOS; XmAb20717: a bispecific antibody targeting PD-1 and CTLA-4 bispecific antibody; BOR: best overall response rate.