Title: A Randomized Phase 2 Study of Nivolumab Monotherapy Versus Nivolumab Combined With Ipilimumab in Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor (GIST)1
Principal Investigator: Arun Singh, MD, Jonsson Comprehensive Cancer Center
Description: For this open-label phase 2 study (ClinicalTrials.gov Identifier: NCT02880020), researchers are comparing the efficacy of nivolumab monotherapy with that of nivolumab plus ipilimumab in patients with an unresectable or metastatic GIST.
Patients will receive intravenous (IV) nivolumab on day 1 of 2 week cycles for up to 2 years or IV nivolumab on day 1 of 2 week cycles plus IV ipilimumab every 6 weeks for up to 2 years.
The primary outcome measure is the overall response rate. Secondary outcomes include the clinical benefit rate, toxicity, progression-free survival, and response rate by Choi criteria.
The estimated study enrollment is 40 patients.
For more study information, including exclusion and inclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02880020.
Status: Open and recruiting patients as of November 22, 2017.
This study is sponsored by the Jonsson Comprehensive Cancer Center in collaboration with the National Cancer Institute.
- ClinicalTrials.gov. Nivolumab with or without ipilimumab in treating patients with gastrointestinal stromal tumor that is metastatic or cannot be removed by surgery. NCT02880020. https://clinicaltrials.gov/ct2/show/NCT02880020. Accessed November 22, 2017.