Randomized Phase II Study of Nivolumab with or without Ipilimumab in Patients with Metastatic or Unresectable Sarcoma.

Research & Trial Information

SCHEMA A091401

Protocol #: A091401

Cancer Type: Sarcoma

Eligibility Criteria:

  1. Patients must have histologically confirmed bone or soft tissue sarcoma by central pathology review.
  2. Measurable disease.  Locally advanced/unresectable or metastatic disease.
  3. Prior Treatment• ≥ 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy.

    • No prior therapy with ipilimumab or nivolumab, or any agent targeting PD-1, PD-L1 or CTLA-4.

    • No treatment with biologic therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration. For GIST, tyrosine kinase inhibitor can be continued for up to 3 days prior to initiation of study treatment.

    • Patients should have resolution of any toxic effects of prior therapy

  4. No history of the following:• Active known or suspected autoimmune disease.

    • Patients with HIV are eligible if the lymphocytes > 350 CD4+ cells and no detectable viral load

    • Symptomatic, untreated, or uncontrolled brain metastases present.

    • Active autoimmune colitis

    • Autoimmune panhypopituitarism

    • Autoimmune adrenal insufficiency

    • Known active hepatitis B or C

  5. No systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of registration.
  6. Age ≥ 18 years.
  7. ECOG Performance Status 0 or 1.


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