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

NCT04480502 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: KN035SAR201
• Study Type: interventional
• Target: 207
• Locations: 2 countries
• Sites: 30

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.

Conditions

Undifferentiated Pleomorphic Sarcoma; Myxofibrosarcoma

Keywords

sarcoma

Outcome Measures

Primary Outcomes (1)

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

  40 months

Secondary Outcomes (9)

• Duration of response (DR) assessed by blinded independent central review

  40 months

• Disease control rate (DCR) assessed by blinded independent central review

  40 months

• Progression free survival (PFS) assessed by blinded independent central review

  40 months

• Overall survival (OS)

  40 months

• Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab

  40 months

Study Arms (4)

Cohort A

EXPERIMENTAL

Patients treated with 300 mg of single agent envafolimab every three weeks

Biological: Envafolimab

Cohort B

EXPERIMENTAL

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.

Biological: Envafolimab; Drug: Ipilimumab

Cohort C

EXPERIMENTAL

Patients treated with 600 mg of single agent envafolimab every three weeks

Biological: Envafolimab

Cohort D

EXPERIMENTAL

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.

Biological: Envafolimab; Drug: Ipilimumab

Interventions

Envafolimab BIOLOGICAL

PD-L1 single domain antibody for subcutaneous injection.

Also known as: KN035

Cohort A; Cohort B; Cohort C; Cohort D

Ipilimumab DRUG

CTLA-4 monoclonal antibody

Also known as: Yervoy

Cohort B; Cohort D

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tracon Pharmaceuticals Inc.: lead

Study Sites (30)

University of Arizona

Tucson, Arizona, 85721, United States

Location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Sarcoma Oncology Research Center

Santa Monica, California, 90403, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Mayo Clinic, Jacksonville

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55901, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63130, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

University Hospitals

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 89106, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19106, United States

Location

Thomas Jefferson University (Sidney Kimmel Cancer Center)

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Vanderbilt University

Nashville, Tennessee, 37235, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Medical College of Wisconsin

Wauwatosa, Wisconsin, 53226, United States

Location

Royal Marsden

London, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Histiocytoma, Malignant Fibrous; Dermatofibrosarcoma; Sarcoma

Interventions

envafolimab; Ipilimumab

Condition Hierarchy (Ancestors)

Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Fibrosarcoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Charles Theuer, MD, PhD

  Tracon Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: December 9, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

GB (1); US (29)