Table 1.
Clinical trials for immune checkpoint blockade in soft tissue sarcoma.
| NCT Identifier | Phase | Title | Sarcoma Subtype(s) | Immune Checkpoint Therapy | Additional Interventions | Sponsor/Collaborators |
|---|---|---|---|---|---|---|
| NCT02428192 | Phase II | Nivolumab Alone or in Combination with Ipilimumab in Treating Patients with Advanced Uterine Leiomyosarcoma | Advanced uterine LMS | Nivolumab +/- Ipilimumab | -- | National Cancer Institute (NCI) |
| NCT02815995 | Phase II | A Phase II Multi-Arm Study to Test the Efficacy of Immunotherapeutic Agents in Multiple Sarcoma Subtypes | Multiple (soft tissue sarcoma and osteosarcoma) | Durvalumab and tremelimumab, followed by druvalumab | -- | MD Anderson Cancer Center, MedImmune |
| NCT02301039 | Phase II | SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients with Advanced Sarcomas | LMS, poorly differentiated/ de-differentiated LPS, high grade UPS/MFH, MPNST, and synovial sarcoma | Pembrolizumab | -- | Sarcoma Alliance for Research through Collaboration, Merck Sharp & Dohme |
| NCT02500797 | Phase II | Randomized Phase II Study of Nivolumab with or without Ipilimumab in Patients with Metastatic or Unresectable Sarcoma | Dedifferentiated/pleomorphic LPS, UPS/MFH, GIST | Nivolumab +/- Ipilimumab | -- | National Cancer Institute (NCI) |
| NCT03317457 | Phase II | A Randomized Phase II Study of Durvalumab (MEDI4736) and Tremelimumab Compared to Doxorubicin in Patients with Advanced or Metastatic Soft Tissue Sarcoma | Fibrosarcoma, UPS, LMS, LPS, malignant glomus tumor, RMS, angiosarcoma, synovial sarcoma, and MPNST | Durvalumab and Tremelimumab | vs Doxorubicin | AIO-Studien-gGmbH, AstraZeneca |
| NCT01643278 | Phase I | Phase I Study of Dasatinib in Combination with Ipilimumab for Patients with Advanced Gastrointestinal Stromal Tumor and Other Sarcomas | GIST and other sarcoma subtypes | Ipilimumab | Dasatinib | National Cancer Institute (NCI) |
| NCT02406781 | Phase II | Combination of MK3475 and Metronomic Cyclophosphamide in Patients with Advanced Sarcomas: Multicentre Phase II Trial (PEMBROSARC) | LMS, UPS, osteosarcoma, GIST, others | Pembrolizumab | Metronomic Cyclophospha-mide (Week on/Week off schedule) | Institut Bergonié, Merck Sharp & Dohme Corp., Ministry of Health, France |
| NCT03138161 | Phase I/II | Phase 1/2 Study of Safety/Efficacy Using TRABECTEDIN, IPILIMUMAB and NIVOLUMAB Triple Therapy as First Line Treatment of Advanced Soft Tissue Sarcoma | Soft Tissue Sarcoma | Ipilimumab, Nivolumab | Trabectedin | Sarcoma Oncology Research Center, Bristol-Myers Squibb |
| NCT02888665 | Phase I/II | A Trial of Pembrolizumab in Combination with Doxorubicin as Treatment for Patients with Advanced Sarcomas | Soft Tissue Sarcoma | Pembrolizumab | Doxorubicin | Fred Hutchinson Cancer Research Center, National Cancer Institute (NCI) |
| NCT03123276 | Phase I/II | A Phase I Study to Assess the Safety and Tolerability of Pembrolizumab in Combination with Fixed Rate Gemcitabine Chemotherapy in Patients with Leiomyosarcoma and Undifferentiated Pleomorphic Sarcoma | LMS and UPS | Pembrolizumab | Gemcitabine | Royal Marsden NHS Foundation Trust, Merck Sharp & Dohme |
| NCT03116529 | Phase I/II | Neoadjuvant Anti-PD-L1 (Durvalumab/ MEDI4736) Plus Anti-CTLA-4 (Tremelimumab) and Radiation for High Risk Soft-Tissue Sarcoma | Intermediate- or high-grade Soft Tissue Sarcoma | Durvalumab and Tremelimumab | Radiation (50 Gy, 1.8-2 Gy per fraction plus 15 Gy GRID radiation for bulky disease) | University of Maryland, AstraZeneca |
| NCT03307616 | Phase II | Phase II Study of Neoadjuvant Checkpoint Blockade in Patients with Surgically Resectable Undifferentiated Pleomorphic Sarcoma and Dedifferentiated Liposarcoma | UPS and dedifferentiated LPS | Nivolumab, Ipilimumab | Radiation therapy | M.D. Anderson Cancer Center, Bristol-Myers Squibb |
| NCT03092323 | Phase II | SU2C-SARC032: A Phase II Randomized Controlled Trial of Neoadjuvant Pembrolizumab With Radiotherapy and Adjuvant Pembrolizumab in Patients with High-Risk, Localized Soft Tissue Sarcoma of the Extremity | UPS and dedifferentiated/pleomorphic LPS | Pembrolizumab | Radiation therapy (50 Gy, 2 Gy per fraction) | Sarcoma Alliance for Research through Collaboration, Stand Up to Cancer, Merck Sharp & Dohme |
Abbreviations: LMS Leiomyosarcoma, UPS Undifferentiated Pleomorphic Sarcoma, MFH Malignant Fibrous Histiocytoma, LPS Liposarcoma, MPNST Malignant Peripheral Nerve Sheath Tumor, GIST Gastrointestinal Stromal Tumor, RMS rhabdomyosarcoma, GRID Spatially Fractionated Radiation Therapy