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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 : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Tracon Pharmaceuticals Inc.

Study Description
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Brief Summary:
This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A) or envafolimab combined with ipilimumab (cohort B) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS)/myxofibrosarcoma (MFS) who have progressed on one or two lines of chemotherapy.

Condition or disease Intervention/treatment Phase
Undifferentiated Pleomorphic Sarcoma Myxofibrosarcoma Biological: Envafolimab Drug: Ipilimumab Phase 2

Detailed Description:
This is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort A) or envafolimab combined with ipilimumab (cohort B) in patients with locally advanced, unresectable or metastatic UPS/MFS who have progressed on one or two lines of chemotherapy. Patients will be assigned at random into one of the two cohorts: cohort A of 80 patients who will receive single agent envafolimab (300 mg every 3 weeks by subcutaneous (SC) injection) or cohort B of 80 patients who will receive envafolimab (300 mg every 3 weeks by SC injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Ipilimumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Envafolimab
Patients treated with 300 mg of single agent envafolimab every three weeks
 Biological: Envafolimab
PD-L1 single domain antibody for subcutaneous injection.
Other Name: KN035
Experimental: Envafolimab + Ipilimumab
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


Outcome Measures
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Primary Outcome Measures :
  1. Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review [ Time Frame: 22 months ]

Secondary Outcome Measures :
  1. Duration of response (DR) assessed by blinded independent central review [ Time Frame: 22 months ]
  2. Disease control rate (DCR) assessed by blinded independent central review [ Time Frame: 22 months ]
  3. Progression free survival (PFS) assessed by blinded independent central review [ Time Frame: 22 months ]
  4. Overall survival (OS) [ Time Frame: 22 months ]
  5. Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab [ Time Frame: 22 months ]
  6. Characterize ipilimumab PK in patients given ipilimumab with envafolimab [ Time Frame: 22 months ]
  7. Objective response rate (ORR) by investigator assessment [ Time Frame: 22 months ]
  8. Progression free survival (PFS) by investigator assessment [ Time Frame: 22 months ]
  9. Characterize the immunogenicity of envafolimab and ipilimumab [ Time Frame: 22 months ]

Eligibility Criteria
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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
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Charles Theuer, MD, PhD 858-550-0780 clinicaltrials@traconpharma.com

Locations
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Sponsors and Collaborators
Tracon Pharmaceuticals Inc.
Investigators
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Study Director: Charles Theuer, MD, PhD Tracon Pharmaceuticals Inc.
More Information
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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: September 9, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tracon Pharmaceuticals Inc.:
sarcoma
Additional relevant MeSH terms:
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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