Clinical Trial 20837

• Overview

  Study Title:

  Envasarc: A Pivitol 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

  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.

  Objective:

  - To determine objective response rate (ORR) by RECIST 1.1 by blinded independent central review (BICR) of envafolimab (cohort A), and of envafolimab combined with ipilimumab at 1 mg/kg (cohort B), in separate cohorts of patients with locally advanced, unresectable or metastatic UPS/MFS that has progressed following one or two lines of chemotherapy, without a formal statistical comparison between the two cohorts

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  Envafolimab (); Ipilimumab (); Yervoy (Ipilimumab)

• Inclusion Criteria

  • Histologically confirmed locally advanced or metastatic undifferentiated pleomorphic sarcoma (UPS) or grade > 2 myxofibrosarcoma (MFS) (or grade 1 MFS with documented metastases)
  • Documented progression by radiographic criteria on or following chemotherapy
  • At least one measurable lesion
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Adequate hematologic and organ function
  • UPS/MFS FFPE tumor specimen or slides thereof (fine needle aspiration is not acceptable)), unless archival tissue is unavailable and biopsy is unsafe or unfeasible
  • Other criteria may apply

• Exclusion Criteria

  • Prior treatment with a PD-(L)1 or CTLA-4 inhibitor
  • Prior treatment with any immunomodulatory therapy, including T cell therapy
  • QTcF > 480 ms
  • Autoimmune disease requiring systemic treatment within the past twelve months (Note: Vitiligo, type 1 diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, and conditions, including eczema, not expected to recur in the absence of an external trigger are permitted.)
  • Condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to study treatment (Note: Inhaled and topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent or steroids for the treatment of contrast allergies, are permitted in the absence of active autoimmune disease
  • Interstitial lung disease
  • More than two prior lines (may be combination regimen) of chemotherapy (not including hormonal treatments) for UPS/MFS (neoadjuvant/adjuvant treatment does not count as a line of treatment if completed > 12 months prior to randomization
  • Current treatment or participation on another therapeutic clinical trial.
  • Women who are pregnant or breastfeeding
  • Receipt of systemic anticancer therapy, including investigational agents, within 5 times the agent’s elimination half-life or 14 days of starting study treatment, whichever is shorter.
  • Major surgical procedure or significant traumatic injury within 4 weeks prior to randomization
  • Patients who have received radiotherapy 28 days or less prior to randomization
  • Uncontrolled hypertension as defined in protocol
  • Ascites or pleural effusion that required intervention within 3 months prior to randomization
  • Pericardial effusion (except clinically insignificant trace or small effusion identified by echocardiogram or another imaging study) within three months prior to randomization
  • History of brain involvement with cancer, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease
  • Angina, myocardial infarction, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, arterial embolism, symptomatic pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within 6 months prior to randomization
  • Active bleeding. Patients who have been uneventfully anti-coagulated with a direct Factor Xa inhibitor or low molecular weight heparin are eligible.
  • Hemoptysis within 6 months prior to randomization, unless definitively treated without recurrence for > 28 days prior to randomization.
  • Thrombolytic use (except to maintain i.v. catheters) within 10 days prior to randomization
  • Known active viral or nonviral hepatitis or cirrhosis, except patients with Hepatitis C infection and undetectable virus following treatment are eligible
  • History of prior malignancy unless the cancer is currently in complete remission per Investigator’s judgment; patients with adequately treated basal cell or squamous cell skin cancer, a history of breast cancer and no evidence of disease on hormonal therapy to prevent recurrence or prostate cancer on adjuvant hormonal therapy with undetectable PSA are eligible
  • Known human immunodeficiency virus (HIV) unless CD4+ T cell count > 350 cells/μL with an undetectable viral load
  • Other exclusions may apply

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