Undifferentiated Pleomorphic Sarcoma Clinical Trial
— ENVASARCOfficial title:
ENVASARC: A Pivotal Trial Of Envafolimab, And Envafolimab In Combination With Ipilimumab, In Patients With Advanced Or Metastatic Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma Who Have Progressed On Prior Chemotherapy
Verified date | May 2024 |
Source | Tracon Pharmaceuticals Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A and C) or envafolimab combined with ipilimumab (cohort B and D) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.
Status | Active, not recruiting |
Enrollment | 207 |
Est. completion date | October 2024 |
Est. primary completion date | October 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Marsden | London | |
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Colorado | Aurora | Colorado |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Dana Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | University Hospitals | Cleveland | Ohio |
United States | Ohio State University | Columbus | Ohio |
United States | Duke University | Durham | North Carolina |
United States | Northwestern University | Evanston | Illinois |
United States | Mayo Clinic, Jacksonville | Jacksonville | Florida |
United States | University of California, Los Angeles | Los Angeles | California |
United States | University of Miami | Miami | Florida |
United States | Vanderbilt University | Nashville | Tennessee |
United States | Columbia University | New York | New York |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Thomas Jefferson University (Sidney Kimmel Cancer Center) | Philadelphia | Pennsylvania |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Virginia Commonwealth University | Richmond | Virginia |
United States | Mayo Clinic Rochester | Rochester | Minnesota |
United States | Washington University in St. Louis | Saint Louis | Missouri |
United States | Huntsman Cancer Institute | Salt Lake City | Utah |
United States | Sarcoma Oncology Research Center | Santa Monica | California |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | Stanford University | Stanford | California |
United States | H. Lee Moffitt Cancer Center | Tampa | Florida |
United States | University of Arizona | Tucson | Arizona |
United States | Medical College of Wisconsin | Wauwatosa | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
Tracon Pharmaceuticals Inc. |
United States, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review | 40 months | ||
Secondary | Duration of response (DR) assessed by blinded independent central review | 40 months | ||
Secondary | Disease control rate (DCR) assessed by blinded independent central review | 40 months | ||
Secondary | Progression free survival (PFS) assessed by blinded independent central review | 40 months | ||
Secondary | Overall survival (OS) | 40 months | ||
Secondary | Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab | 40 months | ||
Secondary | Characterize ipilimumab PK in patients given ipilimumab with envafolimab | 40 months | ||
Secondary | Objective response rate (ORR) by investigator assessment | 40 months | ||
Secondary | Progression free survival (PFS) by investigator assessment | 40 months | ||
Secondary | Characterize the immunogenicity of envafolimab and ipilimumab | 40 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05515068 -
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
|
||
Withdrawn |
NCT04906876 -
A Phase 2 Study of 9-ING-41Combined With Chemotherapy in Adolescents and Adults With Advanced Sarcomas
|
Phase 2 | |
Completed |
NCT02565758 -
ABBV-085, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT03307616 -
Nivolumab With and Without Ipilimumab and Radiation Therapy in Treating Patients With Recurrent or Resectable Undifferentiated Pleomorphic Sarcoma or Dedifferentiated Liposarcoma Before Surgery
|
Phase 2 | |
Active, not recruiting |
NCT04420975 -
Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma
|
Phase 1 | |
Terminated |
NCT04099277 -
A Study of LY3435151 in Participants With Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT03899805 -
A Phase II Study of Eribulin and Pembrolizumab in Soft Tissue Sarcomas
|
Phase 2 | |
Active, not recruiting |
NCT03752398 -
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
|
Phase 1 | |
Recruiting |
NCT04055220 -
Efficacy and Safety of Regorafenib as Maintenance Therapy After First-line Treatment in Patients With Bone Sarcomas
|
N/A | |
Withdrawn |
NCT05116800 -
Phase 2 Study of 9-ING-41 With Chemotherapy in Sarcoma
|
Phase 2 | |
Not yet recruiting |
NCT06422806 -
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
|
Phase 2 | |
Active, not recruiting |
NCT03989596 -
Hypofractionated Radiotherapy With Hyperthermia in Unresectable or Marginally Resectable Soft Tissue Sarcomas
|
Phase 2 | |
Not yet recruiting |
NCT03946943 -
Study of Anlotinib Hydrochloride and Toripalimab in Subjects With Unresectable or Metastatic Undifferentiated Pleomorphic Sarcoma
|
Phase 2 | |
Recruiting |
NCT04008238 -
Prospective Identification of Predictive Biomarkers of Trabectedin Efficacy in Non-L Soft-tissue Sarcoma Patients
|
N/A | |
Recruiting |
NCT04123535 -
Focused Ultrasound to Promote Immune Responses for Undifferentiated Pleomorphic Sarcoma
|
N/A | |
Active, not recruiting |
NCT04242238 -
Study of DCC-3014 in Combination With Avelumab in Patients With Advanced or Metastatic Sarcomas
|
Phase 1 | |
Completed |
NCT02584309 -
Doxorubicin With Upfront Dexrazoxane for the Treatment of Advanced or Metastatic Soft Tissue Sarcoma
|
Phase 2 | |
Not yet recruiting |
NCT06277154 -
MASCT-I Combined With Doxorubicin and Ifosfamide for First-line Treatment of Advanced Soft Tissue Sarcoma
|
Phase 2 | |
Recruiting |
NCT03425279 -
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03651375 -
Hypofractionated Radiotherapy With Sequential Chemotherapy in Marginally Resectable Soft Tissue Sarcomas of Extremities or Trunk Wall
|
Phase 2 |