Table 1.
ongoing studies for locally advanced cervical cancer.
Trial | Phase | Treatment regimens | Primary end-point |
---|---|---|---|
NCT04580771 | II | CRT + vaccine PDS0101 SC on days -10, 7, 28, 49, and 170 | Safety and toxicity |
NCT05504642 | II | Induction IT (Nivolumab 3 mg/kg and Ipilimumab 1 mg/kg IV two weeks before CRT) followed by concurrent CRT and IT (Nivolumab 3mg/kg week 1, 3, 5, 7 and Ipilimumab 1mg/kg in week 5) followed by IT maintenance (Nivolumab 3mg/kg every two weeks x12 and Ipilimumab every six weeks x4) | PFS |
NCT05173272 | III | Neoadjuvant chemotherapy (Cisplatin 50 mg/m^2 d1 q21+ Paclitaxel 175 mg/m^2 d1 q21) combined with serplulimab (300mg d1 q21) followed by CRT and BT vs CRT + BT | PFS |
NCT02635360 | II | CRT + BT followed by IT (200 mg of pembrolizumab every 21 days for 3 months) or CRT + BT with concurrent IT (200 mg of pembrolizumab every 21 days for 3 months) | Change in immunologic markers following combination of study drug with CRT and Incidence of dose limiting toxicities |
NCT03833479 | II | CRT + BT vs CRT + BT followed by maintenance IT (Fixed 500 mg TSR-042 dose Q3W for the first 4 doses followed by a fixed 1000 mg TSR-042 dose Q6W for up to 24 months) | PFS |
NCT05492123 | II | CRT + BT vs induction nivolumab (1mg/kg every 3 weeks for 4 cycles)-ipilimumab (3mg/kg every 3 weeks for 4 cycles), followed by nivolumab (240mg every 2 weeks) with CRT and BT | 3-year PFS |
NCT03612791 | II | CRT + BT vs atezolizumab (1200 mg Q3W, starting one week before EBRT (Week -1) and continued as an adjuvant for a total maximum of 20 cycles) with CRT and BT | PFS |
NCT05311566 | II | CRT + BT vs Camrelizumab (200mg, every 2 weeks and continued as an adjuvant) with CRT and BT | 3-year OS rate |
NCT04221945 | III | CRT + BT vs pembrolizumab (200 mg on Day 1 of each 3-week cycle for 5 cycles during CRT followed by pembrolizumab 400 mg IV on Day 1 of each 6-week cycle (Q6W) for an additional 15 cycles.) with CRT and BT | PFS OS |
CRT, chemoradiation therapy; BT, brachytherapy; IT, immunotherapy; PFS, progression-free survival; OS, overall survival.