Nivolumab With or Without Ipilimumab in Treating Patients With Metastatic Sarcoma That Cannot Be Removed by Surgery

Completed · Phase 2

Conditions studied: Locally Advanced Bone Sarcoma, Locally Advanced Dedifferentiated Liposarcoma, Locally Advanced Gastrointestinal Stromal Tumor, Locally Advanced Soft Tissue Sarcoma, Metastatic Bone Sarcoma, Metastatic Liposarcoma, Metastatic Soft Tissue Sarcoma, Metastatic Undifferentiated Pleomorphic Sarcoma, Metastatic Unresectable Sarcoma, Pleomorphic Liposarcoma, Stage III Bone Sarcoma AJCC v7, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Bone Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Stage IVA Bone Sarcoma AJCC v7, Stage IVB Bone Sarcoma AJCC v7, Unresectable Bone Sarcoma, Unresectable Dedifferentiated Liposarcoma, Unresectable Liposarcoma, Unresectable Malignant Gastrointestinal Stromal Tumor, Unresectable Soft Tissue Sarcoma

In brief

This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with sarcoma that has spread from the primary site to other parts of the body (metastatic) or cannot be removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with metastatic or unresectable sarcoma.

Key facts

Study ID

NCT02500797

Run by

National Cancer Institute (NCI)

People needed

164

Starts

2015-08-13

Expected to finish

2023-04-01

Last updated by the study team

2023-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PRE-REGISTRATION ELIGIBILITY CRITERIA:
• Patients must have a formalin-fixed, paraffin-embedded (FFPE) tumor block OR 1 representative hematoxylin and eosin (H\&E) and 20 unstained sarcoma tissue slides available for submission to central pathology review; this review is mandatory prior to registration to confirm eligibility
• REGISTRATION ELIGIBILITY CRITERIA:
• Patients must have histologically confirmed bone or soft tissue sarcoma by central pathology review
• Patients must have histologically confirmed liposarcoma (LPS) (only dedifferentiated and pleomorphic; well differentiated not eligible), undifferentiated pleomorphic sarcoma (UPS)/malignant fibrous histiocytoma (MFH), or gastrointestinal stromal tumor (GIST)
• Measurable disease
• Locally advanced/unresectable or metastatic disease
• >= 1 prior systemic therapy for sarcoma, including adjuvant systemic therapy
• No prior therapy with ipilimumab or nivolumab, or any agent targeting programmed cell death 1 (PD-1), PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (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 (except alopecia) to NCI CTCAE, version 4.0, grade 1 or less
• No history of the following:
• Active known or suspected autoimmune disease
• Patients with human immunodeficiency virus (HIV) are eligible if the lymphocytes > 350 cluster of differentiation (CD)4+ 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
• Hepatitis B can be defined as:
• Hepatitis B surface antigen (HBsAg) > 6 months
• Serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) 20,000 IU/ml (105 copies/ml), lower values 2,000-20,000 IU/ml (104-105 copies/ml) are often seen in hepatitis B e antigen (HBeAg)-negative chronic hepatitis B
• Persistent or intermittent elevation in alanine aminotransferase (ALT)/alanine aminotransferase (AST) levels
• Liver biopsy showing chronic hepatitis with moderate or severe necroinflammation
• Hepatitis C can be defined as:

Where it is running

• Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
• Alaska Regional Hospital — Anchorage, Alaska, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Anchorage Oncology Centre — Anchorage, Alaska, United States
• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• PCR Oncology — Arroyo Grande, California, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Kaiser Permanente-Baldwin Park — Baldwin Park, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Community Cancer Institute — Clovis, California, United States
• University Oncology Associates — Clovis, California, United States
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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