A Phase 2 study intended to see efficacy of tilsotolimod in combination with immunotherapy drugs ipilimumab and nivolumab in different solid tumors.
Description: Efficacy measure by objective response rateMeasure: 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: Durability or response per RECIST v1.1Measure: Duration of response Time: DOR will be evaluated every 8 weeks starting Cycle3 Day1 (each cycle is 28 days) for year 1 then every 12 weeks after the first year through study completion until all study participants have either progressive disease or start new anticancer treatment.
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)
Single Group Assignment
There is one SNP
2. Subjects with BRAF V600E mutations. --- V600E ---