Table 6.
Clinical trials of immune checkpoints inhibitors for patients with osteosarcoma.
| Clinical trial | Phase | Treatment | Intervention | Immunotherapy targets |
|---|---|---|---|---|
| NCT02301039 (SARC028) | II | Pembrolizumab | Pembrolizumab will be administered i.v. at 200 mg every 3 weeks | PD-1 |
| NCT03013127 | II | Pembrolizumab | Pembrolizumab 200 mg i.v. every 3 weeks for up to 35 cycles | PD-1 |
| NCT05182164 (PEMBROCABOSARC) | II | Pembrolizumab + Cabozantinib | Pembrolizumab will be administered i.v on day 1 every 3 weeks (200 mg). Cabozantinib will be administered per OS once daily (40 mg) | PD-1 |
| NCT02500797 | II | Nivolumab | Patients receive nivolumab i.v over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to Arm II. | PD-1 |
| NCT03628209 | I/II | Nivolumab + Zacitidine | Participants will be treated with nivolumab i.v., 3 mg/kg on days 1 and 15 of each cycle. Phase I Dose Escalation - Dose level 1: NA. Dose level 2: 60 mg/m^2. Dose level 3: 75 mg/m^2. Phase II Expansion - Treated at recommended Phase II dose (RP2D). | PD-1 |
| NCT04803877 | II | Regorafenib + Nivolumab | Regorafenib 40 mg + 480 mg i.v. over 30 min every 28 days for patients aged 18 and older; regorafenib 20 mg + nivolumab 3 mg/kg (maximum dose 240 mg) will be administered i.v. over 30 minutes on day 1 and 15 of each 28-day cycle for subjects younger than 18 years; | PD-1 |
| NCT02304458 | I/II | Nivolumab + Ipilimumab | — | PD-1 + CTLA-4 |
| NCT05302921 | II | Nivolumab + Ipilimumab | Nivolumab and ipilimumab will be given on day 1 of 21-day cycles for cycles 1-4, followed by nivolumab alone on days 1 and 15 of 28-day cycles for cycles 5+. Patients will receive up to 13 cycles of therapy unless unacceptable toxicity or progression of disease. | PD-1 + CTLA-4 |
| NCT05019703 (TACOS study) | II | Atezolizumab + Cabozantinib | Patients receive atezolizumab IV over 60 minutes on day 1 and cabozantinib PO QD on days 1-21. | PD-L1 |
| NCT01445379 | I | Ipilimumab | Ipilumumab given on day 1 of a 21-day cycle for 4 cycles, from cycle 5+ | CTLA-4 |
*IV, Intravenous; OS, osteosarcoma.