Undifferentiated Pleomorphic SarcomaPhase 2ENVASARCNCT04480502
ENVASARC: Envafolimab And Envafolimab With Ipilimumab In Patients With Undifferentiated Pleomorphic Sarcoma Or Myxofibrosarcoma
A Phase 2 study testing Envafolimab and Ipilimumab in people with Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma, run by Tracon Pharmaceuticals Inc. at 30 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma
- What is being tested?
- Envafolimab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 9 Dec 2020to Oct 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States29 sites
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Johns Hopkins University
Baltimore, Maryland, 21218
Massachusetts General Hospital
Boston, Massachusetts, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
University Hospitals
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 89106
Ohio State University
Columbus, Ohio, 43210
Duke University
Durham, North Carolina, 27708
Northwestern University
Evanston, Illinois, 60208
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32224
University of California, Los Angeles
Los Angeles, California, 90095
University of Miami
Miami, Florida, 33136
Vanderbilt University
Nashville, Tennessee, 37235
Columbia University
New York, New York, 10027
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19106
Thomas Jefferson University (Sidney Kimmel Cancer Center)
Philadelphia, Pennsylvania, 19107
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Virginia Commonwealth University
Richmond, Virginia, 23284
Mayo Clinic Rochester
Rochester, Minnesota, 55901
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Sarcoma Oncology Research Center
Santa Monica, California, 90403
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University in St. Louis
St Louis, Missouri, 63130
Stanford University
Stanford, California, 94305
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
University of Arizona
Tucson, Arizona, 85721
Medical College of Wisconsin
Wauwatosa, Wisconsin, 53226
About this study
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
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.
Read the 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). Following amendment #4, enrollment into cohort D was terminated and no further interim analyses will be conducted on this cohort.
- Being tested
- Envafolimab, Ipilimumab
- Keywords
- sarcoma
- Medical subject headings
- Histiocytoma, Malignant Fibrous, Dermatofibrosarcoma, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabBiological
Also called KN035
PD-L1 single domain antibody for subcutaneous injection.
IpilimumabDrug
Also called Yervoy
CTLA-4 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Patients treated with 300 mg of single agent envafolimab every three weeks Receives: 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. Receives: Biological: Envafolimab; Drug: Ipilimumab |
| Cohort C | Experimental | Patients treated with 600 mg of single agent envafolimab every three weeks Receives: 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. Receives: Biological: Envafolimab; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review
Measured: 40 months
Secondary outcomes (9)
Duration of response (DR) assessed by blinded independent central review
Measured: 40 months
Disease control rate (DCR) assessed by blinded independent central review
Measured: 40 months
Progression free survival (PFS) assessed by blinded independent central review
Measured: 40 months
Overall survival (OS)
Measured: 40 months
Characterize envafolimab pharmacokinetics (PK) in patients receiving envafolimab as a single agent and in combination with ipilimumab
Measured: 40 months
Characterize ipilimumab PK in patients given ipilimumab with envafolimab
Measured: 40 months
Objective response rate (ORR) by investigator assessment
Measured: 40 months
Progression free survival (PFS) by investigator assessment
Measured: 40 months
Characterize the immunogenicity of envafolimab and ipilimumab
Measured: 40 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start9 Dec 2020
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Undifferentiated Pleomorphic SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tracon Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Theuer, MD, PhD, Study director, Tracon Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480502
- Sponsor's protocol ID
- KN035SAR201
- Acronym
- ENVASARC
- Status last verified
- May 2024
- First submitted
- 16 Jul 2020
- Last updated
- 17 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No