Safety and Efficacy of Epirubicin, Ifosfamide, and Nivolumab as First-line treatment for patients with Undifferentiated Pleomorphic Sarcoma.
[PURPOSE] This single-arm, phase Ib trial aimed to evaluate the safety and preliminary efficacy of epirubicin, ifosfamide, and nivolumab as first-line treatment for advanced UPS.
- 95% CI 7.0-12.7
APA
Martin-Broto J, Martinez-Trufero J, et al. (2026). Safety and Efficacy of Epirubicin, Ifosfamide, and Nivolumab as First-line treatment for patients with Undifferentiated Pleomorphic Sarcoma.. Clinical cancer research : an official journal of the American Association for Cancer Research. https://doi.org/10.1158/1078-0432.CCR-26-0032
MLA
Martin-Broto J, et al.. "Safety and Efficacy of Epirubicin, Ifosfamide, and Nivolumab as First-line treatment for patients with Undifferentiated Pleomorphic Sarcoma.." Clinical cancer research : an official journal of the American Association for Cancer Research, 2026.
PMID
41817407
Abstract
[PURPOSE] This single-arm, phase Ib trial aimed to evaluate the safety and preliminary efficacy of epirubicin, ifosfamide, and nivolumab as first-line treatment for advanced UPS.
[EXPERIMENTAL DESIGN] Adult patients with a centrally confirmed diagnosis of advanced undifferentiated pleomorphic sarcoma were eligible. Patients received epirubicin 60 mg/m² (days 1-2), ifosfamide 3 g/m² (days 1-3) every 21 days for up to six cycles, and nivolumab 360 mg flat dose IV (day 3/ each cycle), followed by maintenance nivolumab for one year. The primary endpoint was the determination of the recommended phase II dose (RP2D).
[RESULTS] Sixteen patients were enrolled with no dose-limiting toxicities observed; the RP2D was established at full-dose epirubicin, ifosfamide, and nivolumab 360 mg. Grade 3-4 treatment-related adverse events included neutropenia (62.5%) and anemia (43.8%). The ORR was 68.8%, with 94% of patients experiencing tumor shrinkage. Median PFS was 9.9 months (95% CI, 7.0-12.7), and median OS was not reached.
[CONCLUSION] The combination of epirubicin, ifosfamide, and nivolumab is a safe, feasible, and highly active treatment for advanced UPS.
[EXPERIMENTAL DESIGN] Adult patients with a centrally confirmed diagnosis of advanced undifferentiated pleomorphic sarcoma were eligible. Patients received epirubicin 60 mg/m² (days 1-2), ifosfamide 3 g/m² (days 1-3) every 21 days for up to six cycles, and nivolumab 360 mg flat dose IV (day 3/ each cycle), followed by maintenance nivolumab for one year. The primary endpoint was the determination of the recommended phase II dose (RP2D).
[RESULTS] Sixteen patients were enrolled with no dose-limiting toxicities observed; the RP2D was established at full-dose epirubicin, ifosfamide, and nivolumab 360 mg. Grade 3-4 treatment-related adverse events included neutropenia (62.5%) and anemia (43.8%). The ORR was 68.8%, with 94% of patients experiencing tumor shrinkage. Median PFS was 9.9 months (95% CI, 7.0-12.7), and median OS was not reached.
[CONCLUSION] The combination of epirubicin, ifosfamide, and nivolumab is a safe, feasible, and highly active treatment for advanced UPS.