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Alliance A091401


Suspended | Phase II

Official Title:

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

Study Purpose:

To test the good and bad side effects of the study drugs called nivolumab and ipilimumab, and learn if the study drugs will shrink your cancer by at least one-quarter compared to its present size.


  • Study agents: Nivolumab and Ipilimumab
  • Lab Biomarker Analysis
  • ARM 1: Nivolumab IV (in a vein) every 2 weeks for up to 2 years. Patients in this arm may be able to “crossover” to Arm 2 if their cancer grows on this arm.
  • ARM 2: Nivolumab IV + Ipilimumab IV every 3 weeks x 4 doses, followed by Nivolumab IV every 2 weeks for up to 2 years.

Patients are followed for 3 years after entering study.

Key Participation Requirements:


Male or Female


19 years and older


Stage IV or Non-Operable Sarcoma

Sarcoma Types:

Liposarcoma (LPS), Undifferentiated Pleomorphic Sarcoma (UPS)/malignant fibrous histiocytoma (MFH), Gastrointestinal Stromal Tumor (GIST)


Must have had at least one prior systemic cancer therapy.

Must have tissue available to send to the study.

No active autoimmune disease.

No treatment with steroids or other immunosuppressive medications.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:


For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!