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Clinical Trials Search

Clinical Trial 20837

Cancer Type: Sarcoma
Study Type: Treatment
NCT#: NCT04480502

Phase: Phase II
Principal Investigator: Druta, Mihaela

Call 813-745-6100
or 1-800-679-0775 Learn More

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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