Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue...
Soft Tissue SarcomaPhase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature. After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened). Patients considered as low-risk according to CINSARC signature will be treated at the discretion of the clinicians (prospective cohort). Patients considered as high-risk according to CINSARC signature will be randomized in the open-label multicenter phase III trial and assigned in one of the two following treatments arms: Arm A (control arm): Standard of care (surgical excision +/- external radiotherapy). Arm B (experimental arm): Standard of care + 4 cycles of intravenous chemotherapy during 12 weeks. A total of 250 patients will have to be randomized with 125 patients in each arm.
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
Cutaneous Squamous Cell CarcinomaSCC - Squamous Cell Carcinoma17 moreParticipants of this study will have a diagnosis of a solid tumor cancer that has come back to its original location or spread beyond its original location (advanced), came back (relapsed) or worsened (refractory) after standard treatments, or no standard treatments are available for the participants' cancer. The purpose of this study if to find the highest dose of MQ710 that causes few or mild side effects in participants with a solid tumor cancer diagnosis.
tTF-NGR Randomized Study - STS
Soft Tissue SarcomaIn this phase III open label, controlled clinical trial patients with unresectable or metastatic soft-tissue sarcoma after failure of anthracycline-containing first line therapy or with contraindications to these drugs and CD13 positivity in central histology (grade >/= 1+) are treated to evaluate whether tTF-NGR in combination with standard trabectedin chemotherapy prolongs progression-free survival (according to iRECIST), as compared with trabectedin alone. Further objectives are to evaluate the efficacy of tTF-NGR in combination with standard trabectedin chemotherapy with respect to the response rate and overall survival as well as to assess the safety profile of tTF-NGR combined with trabectedin. Before the randomized phase III part of the study, there will be a safety run-in part. The final dose of tTF-NGR established as safe in this safety run-in part will be used for the randomized (parallel 1:1; Arm 1: standard trabectedin, Arm 2: standard trabectedin plus tTF-NGR) phase III part of this trail.
A First-In-Human Phase 1 Trial of T-Cell Membrane-Anchored Tumor Targeted Il12 (Attil12)- T-Cell...
Soft Tissue SarcomaBone SarcomaTo find a recommended dose of attIL2-T cell therapy that can be given to patients with soft tissue or bone sarcomas and to see if it can help to control the disease.
Study Evaluating the Safety and Efficacy of MEDI5752 in Combination With Stereotactic Radiotherapy...
Soft Tissue SarcomaThis is a phase I, multicenter, open-label study starting with a dose exploration phase and followed by an expansion phase to evaluate the safety profile and the preliminary activity of the bispecific antibody anti PD-1/CTLA-4 MEDI5752 in combination with SBRT delivered on one lung metastatic lesion, in patients with metastatic soft tissue sarcoma. Dose exploration phase: The primary objective of this dose exploration phase I trial is to determine the Maximum Tolerated Dose and the toxicity profile of MEDI5752 when administrated with stereotactic radiotherapy in patients with metastatic sarcoma with lung metastases. Expansion phase: The primary objective of the expansion phase is to investigate preliminary activity of MEDI5752 when administrated with stereotactic radiotherapy in patients with metastatic sarcoma with lung metastases. A maximum of 20 evaluable patients will be included in this trial.
A Study of XmAb23104 in People With Sarcoma
SarcomaThe purpose of this study is to find out whether the study drug, XmAb23104, is an effective treatment for advanced sarcoma. The researchers will also look at whether XmAb23104 is safe and causes few or mild side effects in participants.
The Combination of Radiotherapy,Surufatinib and Sintilimab in High-Risk Localized Soft Tissue Sarcoma...
High-Risk Localized Soft Tissue SarcomaThis is a prospective, single-center, single-arm, phase Ib/II clinical trial. The study aims to evaluate the safety and efficacy of the treatment which combines radiotherapy, Sintilimab (Anti-PD1 Antibody) and Surufatinib (small-molecule Tyrosine Kinase inhibitor) in patients with high-risk localized soft tissue sarcoma. There will be 52 patients with high-risk localized extremity and trunck soft tissue sarcoma recruited. The trail is designed as a two-stage study. In safety lead-in phase (phase Ib), using 3+3 design, 6 cycles of Surufatinib (250mg, 200mg, qd) and Sintilimab (200mg, q3w) will be applied. And radiotherapy (BED=50-60Gy (α/β=10)) will begin in week 4 of the therapy. In extended phase (phase II), Surufatinib will be applied in the recommended phase 2 dose (RP2D) according to phase Ib. And 200mg Sintilimab and radiotherapy will be applied as before. The dose-limiting toxicity (DLT) in phase Ib and objective response rate (ORR) in phase Ib+Phase II will be mainly analyzed.
Testing Ipilimumab and Nivolumab Combination With or Without Cabozantinib in People >= 18 Years...
Extraskeletal Myxoid ChondrosarcomaLeiomyosarcoma2 moreThis phase II trial compares the effect of ipilimumab and nivolumab combination with cabozantinib, ipilimumab, and nivolumab combination in treating patients >= 18 years old with soft tissue sarcoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is a chemotherapy drug that works by blocking the formation of new blood vessels in tumors, something tumors need to do to grow. Adding cabozantinib to the combination of ipilimumab and nivolumab may be effective in slowing the growth of soft tissue sarcoma tumors.
A Study of Niraparib in People With Soft Tissue Sarcoma Who Have Changes in Their Tumor DNA
Sarcoma,Soft TissueSarcoma UterusThe purpose of this study is to test whether the study drug, niraparib, is effective against unresectable and/or metastatic soft tissue sarcoma with DDR mutations. The researchers will also study whether niraparib is safe and causes few or mild side effects, and whether there are groups of DDR mutations in soft tissue sarcoma cells that respond better to treatment with niraparib.
Immunotherapy Combined With Radiotherapy for Metastatic Sarcoma
SarcomaSoft TissueThis is a pilot study determining the feasibility of combination treatments, pembrolizumab and stereotactic ablative radiotherapy (SBRT) in subjects with soft-tissue sarcoma. These are subjects who have metastatic disease initially, or recurrent or progressive disease that is not eligible for curative surgery.