Trial Search Results

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

The purpose of this study is to determine the effectiveness and safety of envafolimab, an experimental drug that is not approved for use,when given alone or in combination with ipilimumab to stimulate your immune system to attack cancer cells. Both drugs are monoclonal antibodies, which are substances the body makes as part of an immune response (the body's response to infection or something foreign to the body).

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Tracon Pharmaceuticals Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: Envafolimab
  • Drug: Ipilimumab

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

12 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Behnaz (Parsien) Agahian
Behnaz (Parsien) Agahian
Recruiting