Nivolumab With or Without Ipilimumab in Treating Patients With Gastrointestinal Stromal Tumor That Is Metastatic or Cannot Be Removed by Surgery

Conditions

• Gastrointestinal Stromal Tumor

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

Study Details

This randomized phase II trial studies how well nivolumab with or without ipilimumab works in treating patients with gastrointestinal stromal tumor that has spread to other places in the body or cannot be removed by surgery. Monoclonal antibodies, such as nivolumab and ipilimumab, interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date

Dec 14, 2016

Status verified

Oct 2021

Primary completion

Aug 9, 2022

Completion

Aug 9, 2022

Study Design

Enrollment

36 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (nivolumab)
  Patients receive nivolumab IV over 60 minutes on day 1. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (nivolumab, ipilimumab)
  Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 30 minutes every 6 weeks. Courses repeat every 14 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Overall response rate defined as the number of subjects with a best objective response of confirmed CR or PR divided by the number of subjects [ Time Frame: Up to 2 years ]

Locations (1)

Find similar trials in Los Angeles, CA

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