New Protocol: Nivolumab and Trabectedin in Advanced Soft Tissue Sarcoma

Study

Prospective, explorative, two-group, non-randomized, phase II trial (NITraSarc)

Advanced, previously treated lipo-leiomyosarcoma (Group A: GA) (n=43) and non-L-sarcomas (Group B: GB) (n=49)

Early combination cohort (ECC): Trabectedin x2 cycle followed by Nivolumab + Trabectedin and Late combination cohort (LCC): Trabectedin x3 cycle followed by Nivolumab + Trabectedin

Efficacy

mPFS: 5.5 vs 2.3 mos, GA and GB, respectively

6 mos PFS: 47.6% vs. 14.6%, GA and GB, respectively

mPFS: 9.8 vs 4.4 mos, LCC and ECC, respectively

mOS: 18.7 vs.5.6 mos, GA and GB, respectively

mOS: 24.6 vs.13.9 mos, LCC and ECC, respectively

Safety

Grade3 Aes: Unspecified

Journal of Clin Oncol 2023 41:16_suppl, 11500-11500

Efficacy and safety of nivolumab and trabectedin in pretreated patients with advanced soft tissue sarcomas (STS): Results of a phase II trial of the German Interdisciplinary Sarcoma Group (GISG-15, NitraSarc).

http://doi.org/10.1200/JCO.2023.41.16_suppl.11500

Reviewed by Elvin Chalabiyev, MD on Jun 24, 2023