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
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.
- 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
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
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
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