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

Primary Purpose

Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Envafolimab
Ipilimumab
Sponsored by
Tracon Pharmaceuticals Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Undifferentiated Pleomorphic Sarcoma focused on measuring sarcoma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Cohort D

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review

Secondary Outcome Measures

Duration of response (DR) assessed by blinded independent central review
Disease control rate (DCR) assessed by blinded independent central review
Progression free survival (PFS) assessed by blinded independent central review
Overall survival (OS)
Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab
Characterize ipilimumab PK in patients given ipilimumab with envafolimab
Objective response rate (ORR) by investigator assessment
Progression free survival (PFS) by investigator assessment
Characterize the immunogenicity of envafolimab and ipilimumab

Full Information

First Posted
July 16, 2020
Last Updated
April 10, 2023
Sponsor
Tracon Pharmaceuticals Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04480502
Brief Title
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 9, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tracon Pharmaceuticals Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma
Keywords
sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Patients treated with 300 mg of single agent envafolimab every three weeks
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
Patients treated with 600 mg of single agent envafolimab every three weeks
Arm Title
Cohort D
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Envafolimab
Other Intervention Name(s)
KN035
Intervention Description
PD-L1 single domain antibody for subcutaneous injection.
Intervention Type
Drug
Intervention Name(s)
Ipilimumab
Other Intervention Name(s)
Yervoy
Intervention Description
CTLA-4 monoclonal antibody
Primary Outcome Measure Information:
Title
Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review
Time Frame
40 months
Secondary Outcome Measure Information:
Title
Duration of response (DR) assessed by blinded independent central review
Time Frame
40 months
Title
Disease control rate (DCR) assessed by blinded independent central review
Time Frame
40 months
Title
Progression free survival (PFS) assessed by blinded independent central review
Time Frame
40 months
Title
Overall survival (OS)
Time Frame
40 months
Title
Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab
Time Frame
40 months
Title
Characterize ipilimumab PK in patients given ipilimumab with envafolimab
Time Frame
40 months
Title
Objective response rate (ORR) by investigator assessment
Time Frame
40 months
Title
Progression free survival (PFS) by investigator assessment
Time Frame
40 months
Title
Characterize the immunogenicity of envafolimab and ipilimumab
Time Frame
40 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles Theuer, MD, PhD
Phone
858-550-0780
Email
clinicaltrials@traconpharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Theuer, MD, PhD
Organizational Affiliation
Tracon Pharmaceuticals Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85721
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarcoma Oncology Research Center
City
Santa Monica
State/Province
California
ZIP/Postal Code
90403
Country
United States
Individual Site Status
Recruiting
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwestern University
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60208
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55901
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University (Sidney Kimmel Cancer Center)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37235
Country
United States
Individual Site Status
Recruiting
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical College of Wisconsin
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Name
Royal Marsden
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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