Table 1.
Published clinical trials evaluating immune checkpoint inhibitors in the treatment of cervical cancer.
| Ref. | Trial | Phase | Pts | Setting | Drugs and Schedule | Primary Endpoint | Results |
|---|---|---|---|---|---|---|---|
| [40,41] | Frenel et al., 2017 (Keynote 028) | Ib | 24 | Recurrent PD-L1 Positive |
Pembrolizumab 10 mg/kg q2w for up to 2 years | ORR | 17% |
| [42] | Chung et al., 2019 (Keynote 158) | II | 98 | Recurrent | Pembrolizumab 200 mg q3w for up to 2 years | ORR | 12.2% |
| [43] | Naumann et al., 2019 (CheckMate 358) |
I/II | 19 | Recurrent Metastatic HPV+ |
Nivolumab 240 mg q2w for up to 2 years | ORR | 26.3% |
| [48] | Santin et al., 2019 | II | 26 | Persistent Recurrent |
Nivolumab 3 mg/kg q2w until PD or intolerable toxicity | ORR | 4% |
| [49] | Lheureux et al., 2018 | I/II | 42 | Metastatic |
Phase I: Ipilimumab 3 mg/kg q3w for 4 cycles. Phase II: Ipilimumab 10 mg/kg q3w for 4 cycles followed by 4 cycles of maintenance therapy q12w |
ORR and Safety | ORR 2.4% AEs ≥ Gr 3 were reported in 12 pts |
| [50] | Mayadev et al., 2017 | I | 34 | FIGO stage IB2/IIA or IIB/IIIB/IVA and positive nodes | Weekly cisplatin (40 mg/m2) for 6 cycles and extended field radiation → sequential ipilimumab (3 dose levels: 3 mg/kg, 10 mg/kg and an expansion cohort of 10 mg/kg) | MTD and DLT | MTD = 10 mg/kg |
| [52] | Naumann et al., 2019 (CheckMate 358) |
I/II | 91 | Recurrent Metastatic HPV+ |
Combo A: nivolumab 3 mg/kg q2w and ipilimumab 1 mg/kg q6w Combo B: nivolumab 1 mg/kg and ipilimumab 3 mg/kg q3w, for 4 doses followed by nivolumab 240 mg q2w for up to 2 years |
ORR | Without PST: Combo A 32% Combo B 46% With PST: Combo A 23% Combo B 36% |
| [53] | Callahan et al., 2017 | I | 13 * | Non responders Relapsed | Durvalumab 1500 mg q4w and tremelimumab 75 mg q4w × 4 | MTD and safety | Regimen used for expansion phase: Durvalumab 1500 mg q4w and tremelimumab 75 mg q4w × 4. TRAEs ≥ Gr 3 were reported in 12 pts |
| [54] | O’ Malley et al., 2020 | II | 161 | Recurrent Metastatic |
Balstilimab 3 mg/kg q2w up to 2 years | ORR | 14% |
| 155 | Recurrent Metastatic |
Balstilimab 3 mg/kg q2w in combination with zalifrelimab 1 mg/kg q6w up to 2 years | ORR | 22% |
* evaluable; ORR = objective response rate, PD = progression disease, AEs = adverse events, Pts = patients, MTD = maximum tolerated dose, DLT = dose-limiting toxicities, PST = previous systemic therapy.