Table 2.
Completed clinical trials evaluating PD-1 inhibitors in recurrent and/or metastatic nasopharyngeal carcinoma.
| Study | Trial identifier | Key eligibility criteria | Sample size | Dose | ORR | Median PFS (95% CI) | Median OS (95% CI) | Grade 3 or higher AE |
|---|---|---|---|---|---|---|---|---|
| Hsu et al. (88) | NCT02054806 | Unresectable or metastatic disease; failure on standard therapy before; PD-L1 expression in 1% or more of tumor cells or tumor-infiltrating lymphocytes | 27 | Pembrolizumab 10 mg/kg every 2 weeks up to 2 years | 26% | 16.5 (10.1 to NR) | 6.5 (3.6 to 13.4) | 15/27 |
| Ma et al. (89) | NCT02339558 | Recurrent and/or metastatic disease; received at least one prior line of platinum-based chemotherapy | 44 | Nivolumab 3 mg/kg every 2 weeks on a 4-week cycle | 21% | 2.8 (1.8 to 7.4) | 17.1 (10.9 to NR) | 10/44 |
| Delord et al. (89) | NCT02488759 | Recurrent and/or metastatic disease; received less than two prior-line of systemic therapies | 24 | Nivolumab 240 mg every 2 weeks | 21% | 2.4 (1.5 to NR) | NR | 2/24 |
| Fang et al. (90) | NCT02721589 | Recurrent and/or metastatic disease; failure at platinum-based chemotherapy | 93 | Camrelizumab at the prespecified doses of 1 mg/kg, 3 mg/kg, and 10 mg/kg, and a bridging dose of 200 mg per dose once every 2 weeks | 34% | 5.6 (3.3 to 7.9) | NR | 15/93 |
| Fang et al. (90) | NCT03121716 | Recurrent and/or metastatic disease; previously untreated | 23 | Camrelizumab 200 mg on day 1, gemcitabine 1 g/m² on days 1 and 8, and cisplatin 80 mg/m² on day 1 every 3 weeks for six cycles, followed by camrelizumab 200 mg maintenance once every 3 weeks | 91% | NR | NR | 20/23 |
| Wang et al. (91) | NCT02915432 | Recurrent and/or metastatic disease; failure at prior standard chemotherapy, or disease progression within 6 months after adjuvant chemotherapy or chemoradiotherapy | 190 | Toripalimabis 3 mg/kg once every 2 weeks | 21% | 1.9 (1.8 to 3.5) | 17.4 (11.7 to 22.9) | 27/190 |
| Yang et al. (92) | NCT03707509 | Recurrent and/or metastatic disease; previously untreated | 134 | Camrelizumab 200 mg every 3 weeks, cisplatin 80 mg/m2 on day 1 of each 21 day, at most 6 cycles, gemcitabine 1,000 mg/m2, day 1 and day 8 of each 21 days, maximum 6 cycles | 87% | 9.7 (8.3 to 11.4) | NR | 126/134 |
| Even et al. (93) | NCT02605967 | Nonkeratinizing recurrent and/or metastatic NPC, failure at platinum-based chemotherapy | 82 | Spartalizumab 400 mg once every 4 weeks | 18% | 1.9 (1.8 to 3.5) | 25.2 (NR to NR) | 37/87 |
NR, not reached; PFS, progression-free survival; OS, overall survival; AE, adverse event; ORR, overall response rate.