ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma (ENVASARC)
Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma
About this trial
This is an interventional treatment trial for Undifferentiated Pleomorphic Sarcoma focused on measuring sarcoma
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed locally advanced or metastatic undifferentiated pleomorphic sarcoma (UPS) or grade ≥ 2 myxofibrosarcoma (MFS)
- Documented progression following systemic chemotherapy
- At least one measurable lesion
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Adequate hematologic and organ function
Exclusion Criteria:
- More than two prior lines of chemotherapy for UPS/MFS
- Prior immune checkpoint inhibitor or immunomodulatory therapy
- Active autoimmune disease that has required systemic treatment
- Major surgery within 4 weeks of dosing of investigational agent
- Active additional malignancy
- Pericardial effusion, pleural effusion, or ascites
- Central nervous system metastases and/or carcinomatous meningitis
- Active hepatitis or cirrhosis
- Interstitial lung disease
- Unwilling to apply highly effective contraception during the study
- Other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study
Sites / Locations
- University of ArizonaRecruiting
- University of California, Los AngelesRecruiting
- Sarcoma Oncology Research CenterRecruiting
- Stanford UniversityRecruiting
- University of ColoradoRecruiting
- Mayo Clinic, JacksonvilleRecruiting
- University of MiamiRecruiting
- H. Lee Moffitt Cancer CenterRecruiting
- Northwestern UniversityRecruiting
- Johns Hopkins UniversityRecruiting
- Massachusetts General HospitalRecruiting
- Dana Farber Cancer InstituteRecruiting
- University of MichiganRecruiting
- Mayo Clinic RochesterRecruiting
- Washington University in St. LouisRecruiting
- Columbia UniversityRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Duke UniversityRecruiting
- University HospitalsRecruiting
- Cleveland ClinicRecruiting
- Ohio State UniversityRecruiting
- University of PennsylvaniaRecruiting
- Thomas Jefferson University (Sidney Kimmel Cancer Center)Recruiting
- University of PittsburghRecruiting
- Vanderbilt UniversityRecruiting
- Huntsman Cancer InstituteRecruiting
- Virginia Commonwealth UniversityRecruiting
- Seattle Cancer Care AllianceRecruiting
- Medical College of WisconsinRecruiting
- Royal MarsdenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort A
Cohort B
Cohort C
Cohort D
Patients treated with 300 mg of single agent envafolimab every three weeks
Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 300 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.
Patients treated with 600 mg of single agent envafolimab every three weeks
Patients treated with envafolimab in combination with ipilimumab. Envafolimab will be given at 600 mg every three weeks. Ipilimumab will be given at 1 mg/kg every three weeks for a total of four doses.