SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03865082

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors

A Phase 2 study intended to see efficacy of tilsotolimod in combination with immunotheraphy drugs ipilimumab and nivolumab in different solid tumors.

NCT03865082 Solid Tumor

3 Interventions

Name: Tilsotolimod

Description: 9 doses of Tilsotolimod Intratumoral injection administered as a dose of 8mg at Day -7 (7 days prior to the start of Cycle 1), Day 1 and Day 8 of Cycle 1, and on Day 1 of Cycles 2 through 7.

Type: Drug

IO Naive Subjects RM SCCHN IO Naive Subjects MSS CRC

Name: Nivolumab

Description: Specified dose on specified days.

Type: Drug

IO Naive Subjects RM SCCHN IO Naive Subjects MSS CRC

Name: Ipilimumab

Description: Specified dose on specified days.

Type: Drug

IO Naive Subjects RM SCCHN IO Naive Subjects MSS CRC


Primary Outcomes

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).

Secondary Outcomes

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 ipilimumab

Measure: 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 ipilimumab

Measure: 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

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

2. Subjects with BRAF V600E mutations. --- V600E ---



HPO Nodes