ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma (ENVASARC)
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ClinicalTrials.gov Identifier: NCT04480502 |
Recruitment Status :
Recruiting
First Posted : July 21, 2020
Last Update Posted : April 8, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Undifferentiated Pleomorphic Sarcoma Myxofibrosarcoma | Biological: Envafolimab Drug: Ipilimumab | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 230 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | December 9, 2020 |
Estimated Primary Completion Date : | June 2024 |
Estimated Study Completion Date : | June 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort A
Patients treated with 300 mg of single agent envafolimab every three weeks
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Biological: Envafolimab
PD-L1 single domain antibody for subcutaneous injection.
Other Name: KN035 |
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.
|
Biological: Envafolimab
PD-L1 single domain antibody for subcutaneous injection.
Other Name: KN035 Drug: Ipilimumab CTLA-4 monoclonal antibody
Other Name: Yervoy |
Experimental: Cohort C
Patients treated with 600 mg of single agent envafolimab every three weeks
|
Biological: Envafolimab
PD-L1 single domain antibody for subcutaneous injection.
Other Name: KN035 |
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.
|
Biological: Envafolimab
PD-L1 single domain antibody for subcutaneous injection.
Other Name: KN035 Drug: Ipilimumab CTLA-4 monoclonal antibody
Other Name: Yervoy |
- Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review [ Time Frame: 40 months ]
- 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 ]

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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04480502
Contact: Charles Theuer, MD, PhD | 858-550-0780 | clinicaltrials@traconpharma.com |

Study Director: | Charles Theuer, MD, PhD | Tracon Pharmaceuticals Inc. |
Responsible Party: | Tracon Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT04480502 |
Other Study ID Numbers: |
KN035SAR201 |
First Posted: | July 21, 2020 Key Record Dates |
Last Update Posted: | April 8, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
sarcoma |
Sarcoma Histiocytoma, Malignant Fibrous Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Histiocytoma Neoplasms, Fibrous Tissue |
Neoplasms, Connective Tissue Ipilimumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |