Table 3.
Ongoing clinical trials of immunotherapy in STS.
| NCT | Histotype | Setting | Molecule | Phase | Number of patients | Estimated Completion Date |
|---|---|---|---|---|---|---|
| Immune checkpoint inhibitors | ||||||
| NCT03141684 | ASPS | Metastatic | Atezolizumab | II | 46 | October 2021 |
| NCT02815995 | All STS | Metastatic | Durvalumab + tremelimumab | II | 150 | August 2020 |
| NCT04274023 | Clear Cell Sarcoma | Metastatic | TSR-042 (anti-PD1) | II | 16 | May 2024 |
| NCT04480502 | UPS | Metastatic | Envafolimab (anti-PD-L1) +/- ipilimumab | II | 160 | July 2022 |
| NCT04118166 | All STS | Metastatic | Nivolumab + ipilimumab + cryotherapy | II | 30 | October 2025 |
| NCT03465592 | All STS, <40yo | Metastatic | Nivolumab following relapse after allogeneic bone marrow transplant | II | 39 | March 2026 |
| NCT03465592 | MPNST | Neoadjuvant | Nivolumab + ipilimumab | II | 18 | January 2025 |
| NCT02691026 | MPNST | Metastatic | Pembrolizumab | II | 18 | December 2025 |
| Antiangiogenic therapy + Immune checkpoint inhibitors | ||||||
| NCT03711279 | All STS | Metastatic | Camrelizumab (anti-PD1) + apatinib vs. doxorubicin + ifosfamide | II | 289 | September 2022 |
| NCT04551430 | All STS | Metastatic | Cabozantinib + nivolumab + ipilimumab | II | 105 | January 2027 |
| NCT03798106 | All STS | Metastatic | Pazopanib + durvalumab | II | 37 | August 2022 |
| NCT03277924 | All STS | Metastatic | Nivolumab + sunitinib | I/II | 270 | September 2022 |
| NCT04172805 | All STS | Metastatic | Anlotinib + toripalimab (anti-PD1) | II | 70 | June 2022 |
| NCT03946943 | UPS | Metastatic | Anlotinib + toripalimab (anti-PD1) | II | 25 | July 2023 |
| Other targeted therapies + Immune checkpoint inhibitors | ||||||
| NCT04438824 | WDLPS, DDLPS | Metastatic | Palbociclib + INCMGA00012 (anti-PD1) | II | 30 | June 2023 |
| NCT04216953 | All STS | Metastatic | Cobimetinib + atezolizumab | I/II | 120 | February 2024 |
| NCT04624178 | LMS | Metastatic | Rucaparib + nivolumab | II | 20 | November 2022 |
| NCT03126591 | All STS | Metastatic | Olaratumab + pembrolizumab | I | 41 | March 2021 |
| Chemotherapy + Immune checkpoint inhibitors | ||||||
| NCT03899805 | LPS, LMS, UPS | Metastatic | Eribulin + pembrolizumab | II | 57 | August 2024 |
| NCT03802071 | All STS | Metastatic, anthracycline-naïve | Doxorubicin + durvalumab | II | 44 | August 2022 |
| NCT03317457 | All STS | Metastatic, anthracycline-naïve | Doxorubicin + durvalumab + tremelimumab | II | 100 | June 2022 |
| NCT04535713 | All STS | Metastatic | Gemcitabine + doxorubicine + docetaxel + nivolumab | II | 260 | September 2025 |
| NCT03719430 | All STS | Metastatic | Doxorubicin + APX005M (CD40 agonistic antibody) | II | 27 | December 2023 |
| NCT04356872 | UPS, Synovial Sarcoma, DDLPS, MRLPS | Metastatic, anthracycline-naïve | Sintilimab (anti-PD1) + doxorubicin + ifosfamide | II | 45 | March 2023 |
| NCT04606108 | All STS | Neoadjuvant | Camrelizumab + neoadjuvant chemotherapy (investigator’s choice) | II | 63 | March 2024 |
| NCT04577014 | All STS | Metastatic | INCMGA00023 (anti-PD1) + gemcitabine + docetaxel | II | 74 | September 2022 |
| NCT04028063 | All STS | Metastatic, anthracycline-naïve | Doxorubicin + AGEN1884 (anti-CTLA-4) + AGEN2034 (anti-PD1) | II | 28 | November 2022 |
| NCT03512834 | Angiosarcoma | Metastatic, first line | Paclitaxel + avelumab | II | 32 | May 2023 |
| NCT03536780 | LMS | Metastatic, second line | Gemcitabine + avelumab | II | 38 | February 2022 |
| NCT03123276 | All STS | Metastatic | Gemcitabine + pembrolizumab | I/II | 24 | December 2020 |
| NCT03085225 | All STS | Metastatic | Trabectedin + durvalumab | Ib | 50 | May 2021 |
| NCT03590210 | All STS | Metastatic | Trabectedin + nivolumab | II | 92 | July 2022 |
| NCT03138161 | All STS | Metastatic | Trabectedin + nivolumab + ipilimumab | I/II | 45 | March 2021 |
| NCT04650984 | All STS | Metastatic, anthracycline-naïve | Doxorubicin vs. doxorubicin + L19TNF (TNFα agonist) | III | 102 | December 2024 |
| NCT04332874 | UPS, ASPS | Metastatic | Isolated limb infusion (dactinomycin + melphalan) + pembrolizumab | II | 30 | April 2023 |
| Epigenetic therapy + Immune checkpoint inhibitors | ||||||
| NCT04025931 | All STS | Metastatic | Chidamide (HDAC inhibitor) + toripalimab (anti-PD1) | II | 53 | July 2021 |
| Radiotherapy + Immune checkpoint inhibitors | ||||||
| NCT03116529 | All STS | Neoadjuvant | Durvalumab + tremelimumab + radiotherapy | II | 35 | June 2022 |
| NCT03463408 | All STS | Neoadjuvant | Nivolumab + ipilimumab + radiotherapy | II | 24 | August 2025 |
| NCT03307616 | UPS DDLPS |
Neoadjuvant | Nivolumab +/- ipilimumab | II | 32 | October 2021 |
| NCT03548428 | LMS, UPS, LPS | Metastatic | Stereotactic ablative radiotherapy + atezolizumab | II | 103 | December 2021 |
| NCT02992912 | All STS | Metastatic | Stereotactic ablative radiotherapy + atezolizumab | II | 187 | October 2020 |
| NCT03338959 | All STS | Metastatic | Radiation therapy + pembrolizumab | II | 26 | June 2022 |
| NCT03092323 | UPS, WDLPS, DDLPS | Neoadjuvant + adjuvant | Radiotherapy vs. radiotherapy + pembrolizumab | II | 102 | July 2025 |
| NCT03474094 | All STS | Neoadjuvant + adjuvant | Radiotherapy + atezolizumab | II | 22 | July 2021 |
| New immunotherapeutic agents + Immune checkpoint inhibitors | ||||||
| NCT04668300 | Angiosarcoma DDLPS Osteosarcoma |
Metastatic | Durvalumab + oleclumab (anti-CD73) | II | 75 | June 2024 |
| NCT04095208 | All STS | Metastatic | Relatlimab (anti-LAG3) + nivolumab | II | 67 | September 2024 |
| NCT03063632 | Synovial Sarcoma | Metastatic | IFNγ-1b + pembrolizumab | II | 30 | May 2021 |
| NCT04242238 | All STS | Metastatic | Avelumab + DCC-3014 (anti-CSF1R) | Ib | 48 | January 2022 |
| NCT03282344 | Chondrosarcoma, Osteosarcoma, UPS, vascular sarcoma, ASPS, DDLPS, pLPS, LMS | Metastatic | Nivolumab + NKTR-214 (pegylated IL-2) | II | 85 | April 2021 |
| NCT04420975 | All STS | Metastatic | Nivolumab + intratumoral BO-112 (double-strand RNA) | I | 25 | January 2025 |
| NCT03414229 | All STS | Metastatic | Pembrolizumab + epacadostat | II | 30 | January 2021 |
| Immune checkpoint inhibitors + Oncolytic virus | ||||||
| NCT03069378 | All STS | Metastatic | T-VEC + pembrolizumab | II | 60 | March 2021 |
| NCT03886311 | All STS | Metastatic | T-VEC + nivolumab + trabectedin | II | 40 | December 2022 |
| Vaccine therapy | ||||||
| NCT01883518 | All STS | Metastatic | Autologous DC vaccine loaded with allogeneic tumor lysate expression of CTA | II | 48 | September 2020 |
| NCT01803152 | All STS | Metastatic | Autologous DC vaccine loaded with allogeneic tumor lysate expression of CTA + gemcitabine | I | 19 | July 2024 |
| NCT02700230 | MPNST | Metastatic | Intratumoral administration of measles virus genetically engineered to express NF1 | I | 30 | June 2021 |
| Adoptive cellular therapy | ||||||
| NCT03725605 | All STS | Metastatic | Intratumoral LTX-315 (oncolytic peptide) followed by TIL culture, expansion and infusion | II | 6 | February 2023 |
| NCT04044768 | HLA-A*02, MAGE-A4 expressing MRLPS/Synovial Sarcoma | Metastatic | Anti-MAGE-A4 SPEAR T-cell | II | 45 | November 2034 |
| NCT02650986 | Tumors expressing NY-ESO1* | Metastatic | NY-ESO1 TCR-transduced TILs +/- decitabine | I/IIa | 27 | June 2021 |
| NCT04052334 | All STS, <40yo | Metastatic | TIL infusion + IL-2 after lymphodepletion | I | 15 | August 2022 |
| NCT03250325 | Synovial Sarcoma with HLA-A*02:01 or HLA-A*02:06 | Metastatic | NY-ESO-1-specific TCR gene transduced T cells | I/II | 8 | January 2020 |
| NCT03399448 | Synovial Sarcoma MRLPS |
Metastatic | NY-ESO-1-specific TCR gene transduced T cells | I | NA | October 2020 |
| NCT03240861 | HLA-A*0201 positive, NY-ESO-1 expressing tumors* | Metastatic | NY-ESO-1-specific TCR gene transduced PBMC + PBSC | I | 12 | September 2022 |
| NCT03450122 | HLA-A*0201 positive, NY-ESO-1 expressing STS | Metastatic | NY-ESO-1-specific TCR gene transduced T cells + IL-2 +/- DC-targeting lentiviral vector LV305 or CMB305 (LV305 + NY-ESO-1 protein vaccine + TLR4) | II | 18 | June 2021 |
| NCT00902044 | HER2-positive sarcoma | Metastatic | HER-2-CAR T cells | II | 36 | July 2032 |
| NCT03356782 | STS with at least 1 target antigen positive IHC | Metastatic | Sarcoma-specific CAR T cells | I/II | 20 | December 2023 |
| NCT04318964 | HLA-A*0201 positive, NY-ESO-1 expressing STS | Metastatic | TAEST16001 cells : NY-ESO-1-specific TCR gene transduced T cells + IL-2 | I | 12 | June 2022 |
ASPS, Alveolar soft-part sarcomas; LMS, Leiomyosarcoma; WDLPS, well-differentiated liposarcoma; DDLPS, dedifferentiated liposarcoma; MRLPS, myxoid round-cell liposarcoma; pLPS, pleomorphic liposarcoma; UPS, Undifferentiated pleomorphic sarcomas; DC, dendritic cell; TCR, T-cell receptor; TLR4, toll-like receptor 4; CAR, chimeric antigen receptor; TNFα, Tumor Necrosis Factor α; HDAC, histone deacetylase; CSF1R, colony stimulating factor 1 receptor; PBMC, peripheral blood myeloid cells; PBSC, peripheral blood stem cells; TIL, tumor infiltrating lymphocyte.