A Phase 2 study intended to see efficacy of tilsotolimod in combination with immunotheraphy drugs ipilimumab and nivolumab in different solid tumors.
Description: Efficacy measure by overall response rate (ORR)Measure: Demonstrate the efficacy of intratumoral tilsotolimod in combination with ipilimumab and nivolumab for each cohort Time: ORR defined as a CR or partial response (PR) according to RECIST v1.1, confirmed by imaging ≥ 4 weeks after the initial documentation of response (to occur up to 24 months).
Description: Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms(ECGs), safety and laboratory parameters as assessed by CTCAE v4.03 or higher.Measure: Safety and tolerability of the combination of tilsotolimod with nivolumab and ipilimumab Time: At every study visit (up to 48 months)
Description: Serum concentrations will be determined for tilsotolimod, nivolumab, and ipilimumabMeasure: Evaluate serum concentrations of tilsotolimod, nivolumab, and ipilimumab using sparse blood sampling Time: Screening, Day -7, Cycle 1 Day 1 and Cycle 3 Day 1 (up to 17 weeks). Each cycle is 28 days
Description: Anti-drug anitbody measures of tilsotolimod when combined with nivolumab and ipilimumabMeasure: Immunogenicity of tilsotolimod in combination with nivolumab and ipilimumab Time: Screening, Day -7, Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1, (up to 32 weeks). Each cycle is 28 days
Single Group Assignment
There is one SNP
2. Subjects with BRAF V600E mutations. --- V600E ---