Table 1 Overview of studies using immune checkpoint inhibitors (ICIs) alone or in combination with other drugs in sarcomas
From: Biomarkers for immune checkpoint inhibition in sarcomas – are we close to clinical implementation?
ICI | Combination | NCT | Phase (Status) | Type of Tumor | Clinical Efficacy | ≥ G3 TRAE |
|---|---|---|---|---|---|---|
Atezolizumab | Cabozantinib | NCT05019703 | Phase II (recruiting) | OGS | NA | NA |
± CMB305 | NCT02609984 | Phase II (terminated due to failure to meet efficacy objective) | NY-ESO-1 + sarcoma | Atezolizumab only: 0 CR, 0 PR, 17 SD, 25 PD (n = 44) Atezolizumab + CMB305: 1.8% ORR (95%CI: 0.8–4.2%), 0 CR, 1 PR, 23 SD, 19 SD (n = 45) mPFS: 1.6 months in atezolizumab only arm (n = 43), 2.6 months in atezolizumab + CMB305 arm (n = 45) (HR: 0.9, 95% CI: 0.6–1.3) mOS: 18 months in both arms (atezolizumab only arm: 95% CI, 15.3 to 26.5 and atezolizumab + CMB305 arm: 95% CI, 10.1 to 22.1; HR, 1.2; p = 0.47) | 13 ≥ G3 TRAE reported in atezolizumab only arm 18 ≥ G3 TRAE reported in atezolizumab + CB305 arm | |
Bevacizumab | NCT03141684 | Phase II (recruiting) | ASPS | 1 CR, 14 PR, 1 unconfirmed PR, 25 SD (n = 43) | 10 ≥ G3 TRAE | |
Bevacizumab + rucaparib | NCT03694262 | Phase II (active, not recruiting) | Endometrial cancer, uterine carcinosarcoma | 1 CR, 9 PR, 13 SD (n = 26) | ≥ G3 TRAE reported in 50% patients | |
Cobimetinib | NCT04216953 | Phase I/II (recruiting) | STS | NA | NA | |
Irinotecan + temozolomide + vincristine | NCT04796012 | Phase I/II (recruiting) | Rhabdomyosarcoma, solid tumor | NA | NA | |
NA | NCT04273061 | Phase II (recruiting) | Cancers (breast, gastrointestinal, genitourinary, gynecologic, head and neck, lung, skin, unknown primary tumor), sarcoma | NA | NA | |
NCT04458922 | Phase II (active, not recruiting) | Chondrosarcoma, clear cell sarcoma of soft tissue | 3 SD (n = 9 in grade 2/3 chondrosarcoma cohort) No RECIST objective responses observed (n = 9 in dedifferentiated chondrosarcoma cohort) | Grade 3 TRAEs occurred in 2 patients in dedifferentiated chondrosarcoma cohort (22%), included infusion reaction, myonecrosis, and anemia | ||
RT + surgical resection | NCT03474094 | Phase II (recruiting) | STS | NA | NA | |
SABR | NCT02992912 | Phase II (unknown) | Metastatic tumors (colorectal cancer, NSCLC, RCC, sarcoma) | NA | NA | |
Selinexor | NCT05333458 | Phase II (recruiting) | ASPS, STS | NA | NA | |
Tiragolumab | NCT05286801 | Phase I/II (recruiting) | Epithelioid sarcoma, SMARCB1 or SMARCA4 deficient tumors | NA | NA | |
Tivozanib | NCT05000294 | Phase I/II (recruiting) | Bile duct cancer, breast cancer, gall bladder cancer, neuroendocrine cancer, ovarian cancer, pancreatic adenocarcinoma, prostate cancer, STS, vulvar cancer | NA | NA | |
± Atezolizumab | SBRT | NCT03548428 | Phase II (recruiting) | Sarcoma | NA | NA |
Avelumab | NA | NCT03006848 | Phase II (active, not recruiting) | OGS | No objective responses occurred (17 PD) (n = 18) mPFS: 8 weeks (95% CI: 6.7–9.1 months) | 6 ≥ G3 TRAE |
Trabectedin | NCT03074318 | Phase I/II (terminated due to investigator leaving institute) | LMS, LPS | 2 DLT reported (n = 6) 2 PR (1 confirmed), 11 SD (n = 23) mPFS: 23.4 months | Most common G3 TRAE attributed to study drug were neutropenia and ALT increase No G4/5 TRAE at the Phase 2 dose | |
Camrelizumab | Apatinib | NCT04239443 | Phase II (unknown) | NSCLC, STS, uterine cancer | NA | NA |
Cisplatin + doxorubicin + ifosfamide + methotrexate | NCT04294511 | Phase II (recruiting) | OGS | 31 showed good response (n = 65) | Most common grade 3–4 adverse events were decreased platelet count (44.0%), decreased white blood cell (37.3%), decreased neutrophil count (29.3%), oral mucositis (14.7%), increased alanine aminotransferase (12.0%), and increased aspartate aminotransferase (10.7%) | |
Ifosfamide + liposome doxorubicin | NCT04606108 | Phase II (recruiting) | STS | NA | NA | |
± Camrelizumab | Famitinib ± ifosfamide | NCT04044378 | Phase I/II (withdrawn due to toxicity) | OGS | NA | NA |
Durvalumab + ipilimumab + pembrolizumab | NA | NCT05187338 | Phase I/II (recruiting) | Sarcoma, solid tumors | NA | NA |
Envafolimab ± ipilimumab | NA | NCT04480502 | Phase II (recruiting) | MFS, UPS | NA | NA |
Envafolimab + YH001 (anti-CTLA4 antibody) | ± Doxorubicin | NCT05448820 | Phase I/II (recruiting) | Sarcoma | NA | NA |
FAZ053 (anti-PD-L1 antibody) ± spartalizumab | NA | NCT02936102 | Phase I (active, not recruiting) | ASPS, chordoma, solid tumors, TNBC | NA | NA |
Ipilimumab | CD4+ T cells + cyclophosphamide | NCT02210104 | Phase I (withdrawn due to issues with tetramer staining) | Melanoma, sarcoma | NA | NA |
Dasitinib | NCT01643278 | Phase I (completed) | GIST, STS | DLT included grade 3 gastric hemorrhage and anemia 0 CR, 0 PR (n = 28) mPFS: 2.8 months (95% CI: 2.7–3.0 months) (n = 18) mOS: 13.5 months (95% CI: 11.4 months – NR) | 19 ≥ G3 TRAE | |
NA | NCT00140855 | Phase II (terminated due to poor accrual) | SS | 0 CR, 0 PR, 0 SD, 6 PD (n = 6) | 3 ≥ G3 TRAE | |
NCT01445379 | Phase I (completed) | Lymphoma, neuroblastoma, sarcoma, Wilms’ tumor | DLT observed at 10 mg/kg (n = 2) 6 SD for four to ten cycles (clear cell sarcoma, melanoma, OGS, SS) | 11 ≥ G3 TRAE | ||
Ipilimumab + nivolumab | Cabozantinib | NCT04149275 | Phase II (withdrawn due to stoppage of funding by sponsor) | Gynecologic carcinosarcoma | NA | NA |
NCT04551430 | Phase II (active, not recruiting) | STS | NA | NA | ||
± Cabozantinib | NCT05836571 | Phase II (not yet recruiting) | Extraskeletal myxoid chondrosarcoma, LMS, LPS, UPS | NA | NA | |
Cryoablation | NCT04118166 | Phase II (active, not recruiting) | STS | 0 CR, 3 PR, 7 SD, 19 PD (n = 29) | 41 ≥ G3 TRAE | |
NCT05302921 | Phase II (recruiting) | ES, hepatoblastoma, hepatocellular carcinoma, melanoma, neuroblastoma, OGS, rhabdomyosarcoma, Wilms’ tumor | NA | NA | ||
Lurbinectedin | NCT05876715 | Phase II (recruiting) | STS | NA | NA | |
NA | NCT02982486 | Phase II (unknown) | BS, STS | NA | NA | |
NCT03219671 | Phase II (unknown) | Classic Kaposi sarcoma | 87% ORR (n = 15) | 2 ≥ G3 TRAE | ||
NCT04416568 | Phase II (recruiting) | Epithelioid sarcoma, INI1-negative cancers | NA | NA | ||
NCT04465643 | Phase I (recruiting) | MPNST | NA | NA | ||
Pazopanib alone | NCT04741438 | Phase III (recruiting) | Sarcoma | NA | NA | |
Tazemetostat | NCT05407441 | Phase I/II (recruiting) | INI1-negative/SMARCA4-deficient cancers | NA | NA | |
Trabectedin | NCT03138161 | Phase I/II (recruiting) | STS | 8 CR, 11 PR, 58 SD and 11 PD with 21.6% BORR and 87.5% DCR (n = 88) mPFS: 7 months (1–44 months) mOS: 14 months (1–46 months) | 76 ≥ G3 TRAE | |
± Ipilimumab | XmAb23104 | NCT03752398 | Phase I (recruiting) | Solid tumors, UPS | No DLT reported (n = 62) 3 PR in HNSCC, RCC, sarcoma | ≥ G3 TRAE reported in 6 patients 2 ≥ G3 irAEs |
± Ipilimumab or pembrolizumab | INT230-6 | NCT03058289 | Phase I/II (completed) | Cancer, sarcoma | No DLT reported | Incidence of ≥ G3 TRAE was 11% and 14% in INT230-6 only and INT230-6 + pembrolizumab arm 1 G4 neutrophil count decrease reported in INT230-6 + pembrolizumab arm |
± Ipilimumab with nivolumab | Aldesleukin + autologous TIL LN-145 + autologous TIL LN-145-S1 | NCT03449108 | Phase II (recruiting) | Anaplastic thyroid cancer, BS, STS, relapsed/refractory ovarian cancer, TNBC, undifferentiated high grade pleomorphic sarcoma of bone | NA | NA |
LAG525 + spartalizumab | NA | NCT03365791 | Phase II (completed) | Solid and hematologic malignancies, STS | 7.3% ORR (n = 75) mPFS: 2.8 months (95% CI: 2.6–3.1 months) | Serious adverse events in 35 patients reported (n = 76) |
Nivolumab | Anlotinib hydrochloride | NCT04165330 | Phase I/II (active, not recruiting) | NSCLC, SCLC, STS | NA | NA |
± Azacitidine | NCT03628209 | Phase I/II (recruiting) | OGS, sarcoma | NA | NA | |
Bempegaldesleukin | NCT03282344 | Phase II (active, not recruiting) | Sarcoma | 9 PR (n = 77) mPFS: 1.8–7.3 months mOS: 5.9–21.7 months (NR in ASPS and angiosarcoma) | 32 ≥ G3 TRAE 1 possible treatment related death | |
NCT04730349 | Phase I/II (terminated due to changes in business objectives) | ES, recurrent/treatment-resistant cancers | NA | NA | ||
BMS-986205 | NCT04106414 | Phase II (closed to accrual due to lack of observed clinical efficacy) | Endometrial adeno-, carcino-sarcoma | No response in nivolumab only arm (n = 12) 1 PR in nivolumab + BMS-986205 arm (n = 12) mPFS: 7.3 weeks (80% CI: 6.4–15.1 weeks) (nivolumab only), 12.3 weeks (80% CI: 4.1–22.1 weeks) (nivolumab + BMS-986205) mOS: 27.5 weeks (80% CI: 17-NA) (nivolumab only), NR (nivolumab + BMS-986205) | 3 ≥ G3 TRAE in nivolumab only arm 2 ≥ G3 TRAE in nivolumab + BMS-986205 arm | |
BO-112 + RT + surgical resection | NCT04420975 | Phase I (active, not recruiting) | STS | NA | NA | |
Cabozantinib | NCT04514484 | Phase I (recruiting) | Advanced cancer, HIV, Kaposi sarcoma | NA | NA | |
± Cabozantinib S-malate or paclitaxel or paclitaxel only | NCT04339738 | Phase II (active, not recruiting) | Angiosarcoma | Taxane only: 13 PR (n = 21), 13 ORR (n = 18) mPFS: 9.6 months (5.3 months – NR) mOS: 20.5 months (14.4 months – NR) | G3 hypertension reported in 10% patients only | |
Cisplatin + dacarbazine + doxorubicin + epirubicin + ifosfamide + methotrexate + sunitinib | NCT03277924 | Phase I/II (recruiting) | BS, STS | 1 CR, 1 PR, 22 SD, 16 PD (n = 40) mPFS: 3.7 months (95% CI: 3.4–4 months) mOS: 14.2 months (95% CI: 7.1–21.3 months) | 21 ≥ G3 TRAE | |
Docetaxel + doxorubicin + gemcitabine | NCT04535713 | Phase II (recruiting) | Sarcoma | 8 PR, 44SD, 7 PD (n = 59 in intention-to-treat cohort) mPFS: 5.1 months (2.837–7.363 months) mOS: 15.3 months (95%CI: 5.48–25.12 months) | 60 ≥ G3 TRAE | |
NA | NCT03241745 | Phase II (active, not recruiting) | Carcinosarcoma, clear cell carcinoma, endometrial carcinoma, high grade endometrial stromal sarcoma, LMS, undifferentiated sarcoma, uterine cancer | NA | NA | |
NCT03316274 | Phase I (completed) | HIV/AIDS, Kaposi sarcoma | NA | NA | ||
NCT03465592 | Phase I/II (recruiting) | Sarcoma | NA | NA | ||
NCT05224999 | Phase II (recruiting) | Carcinosarcoma | NA | NA | ||
Nab-rapamycin | NCT03190174 | Phase I/II (completed) | Sarcoma and certain cancers | Two DLTs reported at 150 mg/m2 (grade 3 aspartate aminotransferase elevation and grade 4 thrombocytopenia) and 125 mg/m2 (grade 3 suicidal ideation and grade 3 hypophosphatemia) each (n = 26) | 12 ≥ G3 TRAE | |
± Pazopanib | NCT03149120 | Phase II (withdrawn) | STS | NA | NA | |
Pomalidomide | NCT04902443 | Phase I (recruiting) | Kaposi sarcoma, viral Associated Malignancies | NA | NA | |
Regorafenib | NCT04803877 | Phase II (active, not recruiting) | OGS | NA | NA | |
Rucaparib | NCT04624178 | Phase II (active, not recruiting) | LMS | NA | NA | |
Trabectedin | NCT03590210 | Phase II (completed) | STS | mPFS: 5.5 months in LMS/LPS cohort (n = 43), 2.3 months in others (n = 49) mOS: 18.7 months in LMS/LPS cohort (n = 43), 5.6 months in others (n = 49) | NA | |
Trabectedin + T-VEC | NCT03886311 | Phase II (recruiting) | Sarcoma | 3 PR, 30 SD, 6 PD, 7.7% BORR (n = 39) mPFS: 7.8 months (95% CI: 4.1–13.1 months) mOS: 19.3 months (95% CI: 12.8 months-NR) | 3 ≥ G3 TRAE related to nivolumab 38 ≥ G3 TRAE related to trabectedin 1 ≥ G3 TRAE related to T-VEC | |
± Nivolumab | Bempegaldesleukin ± NKTR-262 | NCT03435640 | Phase I/II (terminated due to poor overall results) | CRC, HNSCC, melanoma, Merkel cell carcinoma, RCC, sarcoma, TNBC | 1 DLT reported at 3.84 mg NKTR-262 2 PR (n = 17) | Most frequent treatment-related adverse events were flu-like symptoms, fatigue, nausea, and pruritus |
TPST-1120 | NCT03829436 | Phase I (active, not recruiting) | Advanced cancer, sarcoma | G3 hypertension reported in TPST-1120 monotherapy 3 G3 TRAE reported in combination therapy arm 10 SD (n = 19 in monotherapy arm) | 3 ≥ G3 TRAE in combination therapy arm | |
Nivolumab ± Ipilimumab | NA | NCT02304458 | Phase I/II (completed) | Lymphoma, recurrent/refractory solid tumors or sarcomas | No DLT reported (n = 12) Hodgkin lymphoma (n = 10): 1 CR, 2 PR, 5 SD Neuroblastoma (n = 10): 5 SD Sarcoma (n = 33): 11 SD | 54 ≥ G3 TRAE |
NCT02428192 | Phase II (active, not recruiting) | LMS | mPFS: 1.8 months (95% CI: 0.8 months – unknown) (n = 12) mOS: NR | 14 ≥ G3 TRAE | ||
NCT02500797 | Phase II (active, not recruiting) | Sarcoma | Nivolumab only: 3 PR, 5% ORR (92% CI:1–15%) (n = 38) Nivolumab + Ipilimumab arm: 15% adjusted ORR (92% CI: 6–30%) (n = 41) mPFS: 1.7 months (95% CI: 1.4–4.3 months) (n = 42 in nivolumab only arm), 4.1 months (95% CI: 2.6–4.7 months) (n = 41 in nivolumab + ipilimumab arm) mOS: 10.7 months (95% CI: 5.5–15.4 months) (n = 42 in nivolumab only arm), 14.3 months (95% CI: 9.6 months – not estimable) (n = 41 in nivolumab + ipilimumab arm) | 44 ≥ G3 TRAE in nivolumab only arm 66 ≥ G3 TRAE in nivolumab + ipilimumab arm | ||
RT | NCT03463408 | Phase I (active, not recruiting) | Sarcoma | NA | NA | |
± RT | NCT03307616 | Phase II (active, not recruiting) | DDLPS, UPS | mPFS: 18 months (IQR:8 months – NR in DDLPS), NR (IQR:19 – NR in UPS) mOS: NR | NA | |
Nivolumab ± relatlimab | NA | NCT04095208 | Phase II (recruiting) | STS | NA | NA |
ONC-392 (anti-CTLA4 IgG1 monoclonal antibody) ± pembrolizumab | NA | NCT04140526 | Phase I/II (recruiting) | Sarcoma, solid tumors | NA | NA |
± PD-1 inhibitor (not specified) | Anlotinib hydrochloride | NCT05193188 | Phase II (recruiting) | Chondrosarcoma | NA | NA |
CAB-AXL-ADC | NCT03425279 | Phase I/II (recruiting) | BS, ES, LMS, LPS, melanoma, NSCLC, OGS, refractory sarcoma, solid tumor, SS, STS | NA | NA | |
Pembrolizumab | Antiretroviral therapy | NCT02595866 | Phase I (active, not recruiting) | HIV/AIDS related cancer, Kaposi sarcoma | NA | ≥ G3 TRAE reported in 20% of patients |
APG-115 | NCT03611868 | Phase I/II (recruiting) | Melanomas, MPNST, solid tumors | Cutaneous/uveal melanoma:2 CR, 2 PR (n = 17) Melanoma: 2 CR, 3 PR (n = 38) MPNST: 4 SD (n = 10) LPS: 1 PR (n = 17) | ≥ G3 TRAE reported in ≥ 5% patients | |
Axitinib | NCT02636725 | Phase II (completed) | STS | 0 CR, 8 PR, 9 SD (n = 32) mPFS: 4.7 months in intention-to-treat analysis (95% CI: 3.0–9.4 months) (n = 33), 6.9 months in per-protocol analysis (95% CI: 3.0–9.4 months) (n = 30) mOS: 18.7 months (95% CI: 12.0 months – NR) (n = 33) | 26 ≥ G3 TRAE | |
Cabozantinib | NCT05182164 | Phase II (recruiting) | ES, OGS, STS | NA | NA | |
Cyclophosphamide | NCT02406781 | Phase II (unknown) | Sarcoma | 9 PR, 10 SD (n = 30) mPFS: 4.1 months (95%CI: 1.4–12.5 months) mOS: 18.3 months (95%CI: 8.5 months – NR) | 9 ≥ G3 TRAE (n = 35) | |
Cyclophosphamide + fludarabine | NCT03697824 | Phase II (withdrawn due to internal decision, study will be replaced with a larger monotherapy trial) | NY-ESO-1 and/or LAGE-1a + SS | NA | NA | |
Dactinomycin + melphalan | NCT04332874 | Phase II (recruiting) | ASPS, myxofibrosarcoma, UPS | NA | NA | |
Docetaxel + gemcitabine or + gemcitabine or gemcitabine + vinorelbine or irinotecan or liposomal doxorubicin | NCT02331251 | Phase I/II (terminated as investigator is no longer at site) | Advanced cancer, sarcoma | 2 DLT reported | ≥ G3 TRAE reported in 12 patients (n = 17) | |
Doxorubicin | NCT03056001 | Phase II (completed) | STS | 1 CR, 8 PR, 12 SD, 33% ORR (n = 27) mPFS: 6.9 months mOS: 15 months | 26 ≥ G3 TRAE | |
Doxorubicin hydrochloride | NCT02888665 | Phase I/II (completed) | Sarcoma | No DLT reported Overall: 7 PR, 2 unconfirmed PR, 11 SD, 19% ORR (n = 37) Phase II: 4 PR (n = 31) mPFS: 8.1 months (95%CI: 7.6–10.8 months) mOS: 27.6 months (95%CI: 18.7%—NR) | 24 ≥ G3 TRAE Notable pembrolizumab-related toxic effects included grade 3 adrenal insufficiency (n = 1) and hypothyroidism (n = 7) | |
Epacadostat | NCT03414229 | Phase II (active, not recruiting) | Sarcoma | 1 PR, 47% DCR (CR + PR + SD) (n = 30) mPFS: 7.6 weeks (95% CI: 6.9–26.7 weeks) mOS: 16.9 weeks (95% CI: 9.4 weeks – not estimable) | 7 ≥ G3 TRAE | |
Eribulin | NCT03899805 | Phase II (active, not recruiting) | LPS, LMS, UPS | 1 PR, 5SD, 5.3% ORR (n = 19 in LMS cohort) mPFS: 11.1 weeks in LMS cohort | 68% ≥ G3 TRAE in LMS cohort | |
Gemcitabine | NCT03123276 | Phase I/II (unknown) | LMS, UPS | DLT observed at gemcitabine 1000 mg/m2, but not confirmed in the expansion cohort LMS: 8 SD, 3 PD (n = 11) UPS: 2 PR (n = 2) mPFS: 5.1 months (95% CI: 2–9 months) | NA | |
IFN-γ-1β | NCT03063632 | Phase II (active, not recruiting) | Mycosis Fungoides and Sezary syndrome, myxoid LPS, round cell LPS, SS | NA | NA | |
Lenvatinib | NCT04784247 | Phase II (recruiting) | Sarcoma | NA | NA | |
NCT05147558 | Phase II (recruiting) | Uterine carcinosarcoma | NA | NA | ||
NCT05846724 | Phase II (not yet recruiting) | Relapsed/refractory Kaposi sarcoma | NA | NA | ||
Modified vaccinia virus Ankara vaccine expressing p53 | NCT02432963 | Phase I (not recruiting) | Solid tumors, STS | 1 DLT reported 3 SD (n = 11) | 1 fatal G5 myocarditis reported 10 ≥ G3 TRAE | |
NA | NCT02301039 | Phase II (completed) | BS, STS | 5.0% PR (95% CI: 71.0–16.9%) (n = 40 in BS), 17.5% PR (95% CI: 7.3–32.8%) (n = 40 in STS), 13.0% PR (95% CI: 5.5–25.3%) (n = 53 in expansion cohort) mPFS: 8 weeks (95% CI: 7–9 weeks) (n = 39 in BS), 18 weeks (95% CI: 8–22 weeks) (n = 37 in STS), 8 weeks (95% CI: 7–13 weeks) (n = 53 in expansion cohort) mOS: 52 weeks (95% CI: 40–72 weeks) (n = 42 in BS), 49 weeks (95% CI: 34–73 weeks) (n = 42 in STS), 57 weeks (95% CI: 33–86 weeks) (n = 60 in expansion cohort) | 15 ≥ G3 TRAE in BS 19 ≥ G3 TRAE in STS cohort 19 ≥ G3 TRAE in expansion cohort | |
NCT02691026 | Phase II (terminated due to slow enrollment as a result of low incidence of MPNST and the COVID-19 pandemic) | MPNST | NA | NA | ||
NCT03012620 | Phase II (active, not recruiting) | CNS neoplasm, germ cell/embryonal neoplasms, neuroendocrine carcinoma, NK/T cell lymphoma, ovarian neoplasm, sarcoma, thyroid cancer | 1 CR, 14 PR, 33 SD (n = 98) mPFS: 2.75 months (n = 98 in overall), 7.5 months (ASPS), 6.6 months (chordoma), 2.1 months (DSRCT) mOS: 19/7 months (n = 98 in overall), 10 months (DSRCT) | NA | ||
NCT03013127 | Phase II (terminated due to poor clinical benefits) | OGS | 9 PD with no clinical benefit after 18 weeks of treatment (n = 12) mPFS: 1.7 months (95% CI: 1.2–2.2 months) mOS: 6.6 months (95% CI: 3.8–9.3 months) | 0 ≥ G3 TRAE | ||
NCT03316573 | Phase II (suspended due to low accrual) | Follicular dendritic cell sarcoma, histiocytic sarcoma, interdigitating dendritic cell sarcoma, lymphoma | NA | NA | ||
NCT03469804 | Phase II (active, not recruiting) | Classic and endemic Kaposi sarcoma | 2 CR, 10 PR, 5 SD, 71% BORR (95%CI: 44–90%) (n = 17) | 2 ≥ G3 TRAE | ||
Olaparib | NCT05156268 | Phase II (recruiting) | Endometrial carcinosarcoma | NA | NA | |
Olaratumab | NCT03126591 | Phase I (completed) | STS | 0 CR, 6 CR, 9 SD (n = 28) mPFS: 2.7 months (95% CI:1.3–4.07 months) mOS: 14.8 months (95% CI: 12.6 months – NR) | ≥ G3 TRAE in 2 patients reported | |
± Pazopanib | NCT05679921 | Phase II (not yet recruiting) | STS | NA | NA | |
RT | NCT03338959 | Phase I/II (active, not recruiting) | STS | NA | NA | |
+ RT or SOC alone | NCT03092323 | Phase II (recruiting) | STS | NA | NA | |
T-VEC | NCT03069378 | Phase II (active, not recruiting) | Cutaneous angiosarcoma, epithelioid sarcoma, MFS, UPS (expansion cohort) | 43% BORR (95%CI: 0.1–0.82) (n = 7 in cutaneous angiosarcoma cohort), 0% BORR (n = 3 in epithelioid sarcoma), 11% BORR (95% CI: 0.0–0.48) (n = 9 in MFS/UPS cohort) mPFS: 54 weeks (95% CI: 3 weeks – NR in cutaneous angiosarcoma cohort), NA in cutaneous angiosarcoma cohort, 14.9 weeks (95% CI: 7–110 weeks in MFS/UPS cohort) | 1 ≥ G3 TRAE in cutaneous angiosarcoma cohort | |
Ziv-Aflibercept | NCT02298959 | Phase I (active, not recruiting) | Advanced cancer, sarcoma | No DLT reported Melanoma: 1 CR, 1 PR Mesothelioma: 1 PR RCC: 1 PR mOS: 3.3 months (CRC), (90% CI: 0.6–3.4 months), NR (melanoma), 12.5 months (ovarian), (90% CI: 3.8–13.6 months), NR (others), 15.7 months (RCC) (90% CI: 2.5–15.7 months), | G3 TRAE reported in 19 patients (n = 33) | |
± Pembrolizumab | Bevacizumab ± pegcetacoplan | NCT04919629 | Phase II (recruiting) | Fallopian tube carcinosarcoma, primary peritoneal cancer, recurrent ovarian, fallopian tube cancer | NA | NA |
BT-001 | NCT04725331 | Phase I/II (recruiting) | Sarcoma, solid tumors | NA | NA | |
Eribulin mesylate | NCT05619913 | Phase II (recruiting) | Ovarian carcinosarcoma, uterine carcinosarcoma | NA | NA | |
GI-101 ± lenvatinib or RT | NCT04977453 | Phase I/II (recruiting) | Advanced solid tumors, sarcoma | 1 PR (n = 16 in GI-101 monotherapy), 2 PR (n = 9 in GI-101 + pembrolizumab arm) | ≥ G3 TRAE reported in 3 patients in GI-101 monotherapy arm No ≥ G3 TRAE reported in GI-101 + pembrolizumab arm | |
KVA12123 | NCT05708950 | Phase I/II (recruiting) | Sarcoma, solid tumors | NA | NA | |
MQ719 | NCT05859074 | Phase I (recruiting) | Kaposi sarcoma, solid tumors | NA | NA | |
Mupadolimab ± or ciforadenant | NCT03454451 | Phase I (active, not recruiting) | Advanced cancer, sarcoma | No objective responses by RECIST criteria were observed (n = 34) | 28 ≥ G3 TRAE | |
Nanatinostat + valganciclovir | NCT05166577 | Phase I/II (recruiting) | EBV + LMS, EBV + sarcoma, EBV + solid tumors | NA | NA | |
RT | NCT05488366 | Phase I (recruiting) | STS | NA | NA | |
T3011 | NCT04370587 | Phase I/II (recruiting) | HNSCC, melanoma, NSCLC, sarcoma, solid tumor, squamous cell carcinoma | No DLT reported | No treatment related serious adverse events reported | |
LY3435151 | NCT04099277 | Phase I (terminated due to strategic business decision) | LMS, solid tumors, UPS | NA | NA | |
Pembrolizumab/nivolumab | Autologous HER2 CAR T cells | NCT04995003 | Phase I (recruiting) | HER2 + sarcoma | NA | NA |
Retifanlimab | Docetaxel + gemcitabine | NCT04577014 | Phase I/II (recruiting) | STS | 17% ORR (95% CI: 1%-64%) and 50% (95%: 19%-81%) in the run in (n = 7) and de-escalation (n = 6) cohort, 100% DCR (95% CI: 52%-100%) | 11 ≥ G3 TRAE |
± Retifanlimab | Doxorubicin + ifosfamide | NCT04968106 | Phase II (recruiting) | Resectable sarcoma | NA | NA |
Sintilimab | Doxorubicin hydrochloride + ifosfamide | NCT04356872 | Phase II (unknown) | DDLPS, myxoid liposarcoma, UPS, SS | 62.5% ORR (n = 24) | 1/6 DLT |
Surufatinib + RT | NCT05839275 | Phase Ib/II (recruiting) | High risk localized STS | NA | NA | |
Spartalizumab | NA | NCT04802876 | Phase II (active, not recruiting) | PD-1-high mRNA expressing tumors, sarcoma | NA | NA |
Toripalimab | NA | NCT03474640 | Phase I (active, not recruiting) | Advanced malignancies, chondrosarcoma, STS | NA | NA |