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DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

Primary Objective a To evaluate the RECIST v1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. b To evaluate the overall response rate (ORR, per criteria in Section 10.8) in patients with gestational trophoblastic tumors treated with ipilimumab plus nivolumab combination immunotherapy. c To evaluate the RECIST v1.1 overall response rate (ORR) in patients PD-L1 amplified cancers treated with nivolumab immunotherapy. Secondary Objectives a To evaluate toxicities in each cohort. b To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate iRECIST ORR (iORR), and iRECIST PFS (iPFS) across cohorts and within each cohort. Translational Medicine Objectives a Across strata, to evaluate the association of tumor mutational burden measured by tissue sequencing with durable response (CR or PR lasting 24 weeks or more). b Based on cfDNA, within strata, to describe the mutational load and targeted sequencing of well-known oncogenes and changes in these markers of patients at up to three time points (baseline, Cycle 2, and progression), and across strata to describe associations with survival outcomes. c Within strata, to describe the presence of germline mutations, and across strata to evaluate association with outcome. d Within strata, to describe patient risk category as defined by the Biodesix protein signature and change over time at up to three time points (baseline, Cycle 2, progression), and across strata to evaluate associations with outcomes. e Across strata, to evaluate the association of PD-L1 expression (positive versus negative) with response and survival outcomes. Within strata, to characterize baseline PD-L1 prevalence. f To collect specimens for banking for use in future correlative biomarker research studies.

Primary Objective a To evaluate the RECIST v1.1 overall response rate (ORR) in subsets of patients with advanced rare cancers treated with ipilimumab plus nivolumab combination immunotherapy. b To evaluate the overall response rate (ORR, per criteria in Section 10.8) in patients with gestational trophoblastic tumors treated with ipilimumab plus nivolumab combination immunotherapy. c To evaluate the RECIST v1.1 overall response rate (ORR) in patients PD-L1 amplified cancers treated with nivolumab immunotherapy. Secondary Objectives a To evaluate toxicities in each cohort. b To estimate overall survival (OS), progression-free survival (PFS), clinical benefit rate; and to estimate iRECIST ORR (iORR), and iRECIST PFS (iPFS) across cohorts and within each cohort. Translational Medicine Objectives a Across strata, to evaluate the association of tumor mutational burden measured by tissue sequencing with durable response (CR or PR lasting 24 weeks or more). b Based on cfDNA, within strata, to describe the mutational load and targeted sequencing of well-known oncogenes and changes in these markers of patients at up to three time points (baseline, Cycle 2, and progression), and across strata to describe associations with survival outcomes. c Within strata, to describe the presence of germline mutations, and across strata to evaluate association with outcome. d Within strata, to describe patient risk category as defined by the Biodesix protein signature and change over time at up to three time points (baseline, Cycle 2, progression), and across strata to evaluate associations with outcomes. e Across strata, to evaluate the association of PD-L1 expression (positive versus negative) with response and survival outcomes. Within strata, to characterize baseline PD-L1 prevalence. f To collect specimens for banking for use in future correlative biomarker research studies.