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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
Are there results?
None posted in the registry

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
Show all 11Show fewer
  • 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

Other trials in United States

United Kingdom1 site

  • Royal Marsden

    London, SW3 6JJ

Other trials in United Kingdom

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 groups in NCT04480502
Study groupRoleWhat they receive
Cohort AExperimentalPatients treated with 300 mg of single agent envafolimab every three weeks
Receives: Biological: Envafolimab
Cohort BExperimentalPatients 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 CExperimentalPatients treated with 600 mg of single agent envafolimab every three weeks
Receives: Biological: Envafolimab
Cohort DExperimentalPatients 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.

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

    Measured: 40 months

Secondary outcomes (9)

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

    Measured: 40 months

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

    Measured: 40 months

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

    Measured: 40 months

  4. Overall survival (OS)

    Measured: 40 months

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

    Measured: 40 months

  6. Characterize ipilimumab PK in patients given ipilimumab with envafolimab

    Measured: 40 months

  7. Objective response rate (ORR) by investigator assessment

    Measured: 40 months

  8. Progression free survival (PFS) by investigator assessment

    Measured: 40 months

  9. 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.

  1. First posted21 Jul 2020
  2. Study start9 Dec 2020
  3. Primary completionOct 2024 (estimated)
  4. Study completionOct 2024 (estimated)

Resources

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)
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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) by RECIST 1.1 assessed by blinded independent central review (time frame: 40 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04480502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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