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NCT04480502 Clinical Trial

ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma

Undifferentiated Pleomorphic Sarcoma Clinical Trial

— ENVASARC  

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04480502
Other study ID # KN035SAR201
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 9, 2020
Est. completion date October 2024

Study information
Verified date May 2024
Source Tracon Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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 UPS/MFS who have progressed on one or two lines of chemotherapy. Patients were previously assigned at random into one of two cohorts: cohort A of 80 patients who received single agent envafolimab (300 mg every 3 weeks by subcutaneous (SC) injection) or cohort B of 80 patients who received envafolimab (300 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment #3, patients will be assigned at random into one of two cohorts: cohort C of 80 patients who will receive single agent envafolimab (600 mg every 3 weeks by subcutaneous (SC) injection) or cohort D of 80 patients who will receive envafolimab 600 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). Following amendment #4, enrollment into cohort D was terminated and no further interim analyses will be conducted on this cohort.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Envafolimab
PD-L1 single domain antibody for subcutaneous injection.
Drug:
• Ipilimumab
CTLA-4 monoclonal antibody

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
Tracon Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome
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
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