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Randomized Phase II Study of Nivolumab With or Without Ipilimumab in Patients With Metastatic or Unresectable Sarcoma

Primary objective To evaluate the confirmed response rate of single agent nivolumab and dual agent nivolumab plus ipilimumab in patients with locally advanced/unresectable or metastatic soft tissue sarcoma. Secondary objectives To evaluate adverse event rates (NCI CTCAE v4.0) within each treatment arm. To evaluate duration of response, clinical benefit rate, time to progression, progression-free survival, and overall survival within each treatment arm. Correlative science objectives To potentially detect an early signal of confirmed response rate within a histologically defined patient cohort. To assess the potential association between PD-L1 expression (by IHC) and clinical outcome, within each treatment. To evaluate associations between selected biomarker measured in serial peripheral blood and with clinical efficacy, within each treatment. To evaluate the association between selected biomarker measured in tumor tissue with clinical efficacy, within each treatment. To evaluate the association between baseline tumor mutational burden and neoantigen production with clinical efficacy within each treatment. Exploratory Phase II objectives (Crossover Treatment) To evaluate secondary endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab. To evaluate correlative science objectives endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab.

Primary objective To evaluate the confirmed response rate of single agent nivolumab and dual agent nivolumab plus ipilimumab in patients with locally advanced/unresectable or metastatic soft tissue sarcoma. Secondary objectives To evaluate adverse event rates (NCI CTCAE v4.0) within each treatment arm. To evaluate duration of response, clinical benefit rate, time to progression, progression-free survival, and overall survival within each treatment arm. Correlative science objectives To potentially detect an early signal of confirmed response rate within a histologically defined patient cohort. To assess the potential association between PD-L1 expression (by IHC) and clinical outcome, within each treatment. To evaluate associations between selected biomarker measured in serial peripheral blood and with clinical efficacy, within each treatment. To evaluate the association between selected biomarker measured in tumor tissue with clinical efficacy, within each treatment. To evaluate the association between baseline tumor mutational burden and neoantigen production with clinical efficacy within each treatment. Exploratory Phase II objectives (Crossover Treatment) To evaluate secondary endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab. To evaluate correlative science objectives endpoints within patients crossing over to dual agent nivolumab plus ipilimumab after experiencing progressive disease while receiving single agent nivolumab.