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

Conditions

• 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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ipilimumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Nivolumab — BIOLOGICAL
  Given IV
• Quality-of-Life Assessment — OTHER
  Ancillary studies

Study Details

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 Dates

Start date

Aug 13, 2015

Status verified

Sep 2023

Primary completion

Apr 1, 2019

Completion

Apr 1, 2023

Study Design

Enrollment

164 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (nivolumab)
  Patients receive nivolumab IV over 30 minutes once every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress after 10 weeks on single agent nivolumab may elect to cross over to Arm II.
• Experimental: Arm II (nivolumab, ipilimumab)
  Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 90 minutes once every 3 weeks for 12 weeks. Patients then receive nivolumab IV over 30 minutes every 2 weeks. Cycles repeat every 42 days for up to 108 weeks in the absence of disease progression or unacceptable toxicity. Patients who progress by imaging during the first 12 weeks of therapy may continue treatment, at the discretion of the patient and treating investigator.

Primary Outcome Measure

Number of Participants Who Achieved a Confirmed Response [ Time Frame: Up to 44 months ]

Locations (651)

Find similar trials in Anchorage, AK

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