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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04480502
Recruitment Status : Recruiting
First Posted : July 21, 2020
Last Update Posted : April 12, 2023
Sponsor:
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.

Tracking Information
First Submitted Date  ICMJE July 16, 2020
First Posted Date  ICMJE July 21, 2020
Last Update Posted Date April 12, 2023
Actual Study Start Date  ICMJE December 9, 2020
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2022)		 Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review [ Time Frame: 40 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2020)		 Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review [ Time Frame: 22 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2022)
  • Duration of response (DR) assessed by blinded independent central review [ Time Frame: 40 months ]
  • Disease control rate (DCR) assessed by blinded independent central review [ Time Frame: 40 months ]
  • Progression free survival (PFS) assessed by blinded independent central review [ Time Frame: 40 months ]
  • Overall survival (OS) [ Time Frame: 40 months ]
  • Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab [ Time Frame: 40 months ]
  • Characterize ipilimumab PK in patients given ipilimumab with envafolimab [ Time Frame: 40 months ]
  • Objective response rate (ORR) by investigator assessment [ Time Frame: 40 months ]
  • Progression free survival (PFS) by investigator assessment [ Time Frame: 40 months ]
  • Characterize the immunogenicity of envafolimab and ipilimumab [ Time Frame: 40 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2020)
  • Duration of response (DR) assessed by blinded independent central review [ Time Frame: 22 months ]
  • Disease control rate (DCR) assessed by blinded independent central review [ Time Frame: 22 months ]
  • Progression free survival (PFS) assessed by blinded independent central review [ Time Frame: 22 months ]
  • Overall survival (OS) [ Time Frame: 22 months ]
  • Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab [ Time Frame: 22 months ]
  • Characterize ipilimumab PK in patients given ipilimumab with envafolimab [ Time Frame: 22 months ]
  • Objective response rate (ORR) by investigator assessment [ Time Frame: 22 months ]
  • Progression free survival (PFS) by investigator assessment [ Time Frame: 22 months ]
  • Characterize the immunogenicity of envafolimab and ipilimumab [ Time Frame: 22 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Official Title  ICMJE 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
Brief 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.
Detailed 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Undifferentiated Pleomorphic Sarcoma
  • Myxofibrosarcoma
Intervention  ICMJE
  • Biological: Envafolimab
    PD-L1 single domain antibody for subcutaneous injection.
    Other Name: KN035
  • Drug: Ipilimumab
    CTLA-4 monoclonal antibody
    Other Name: Yervoy
Study Arms  ICMJE
  • Experimental: Cohort A
    Patients treated with 300 mg of single agent envafolimab every three weeks
    Intervention: Biological: Envafolimab
  • Experimental: Cohort B
    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.
    Interventions:
    • Biological: Envafolimab
    • Drug: Ipilimumab
  • Experimental: Cohort C
    Patients treated with 600 mg of single agent envafolimab every three weeks
    Intervention: Biological: Envafolimab
  • Experimental: Cohort D
    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.
    Interventions:
    • Biological: Envafolimab
    • Drug: Ipilimumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 31, 2022)		 230
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2020)		 160
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charles Theuer, MD, PhD 858-550-0780 clinicaltrials@traconpharma.com
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04480502
Other Study ID Numbers  ICMJE KN035SAR201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Tracon Pharmaceuticals Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tracon Pharmaceuticals Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Charles Theuer, MD, PhD Tracon Pharmaceuticals Inc.
PRS Account Tracon Pharmaceuticals Inc.
Verification Date April 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP