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Tilsotolimod

Phase 2

Solid Tumor | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 17, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03865082Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)PHASE2 ACTIVE NOT_RECRUITING 30Oct 29, 2019Apr 1, 2022Feb 17, 20223 United States
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Study Endpoints
Primary Endpoints
Demonstrate the efficacy of intratumoral tilsotolimod in combination with ipilimumab and nivolumab for each cohort
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).

Efficacy measure by objective response rate

Duration of response
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.

Durability or response per RECIST v1.1

Secondary Endpoints
Safety and tolerability of the combination of tilsotolimod with nivolumab and ipilimumab
At every study visit (up to 48 months)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IO Naive Subjects MSS CRCEXPERIMENTAL8mg Tilsotolimod by intratumoral injection plus 3mg/kg Nivolumab (every three weeks for four doses followed by 480mg dose every four weeks) and 1mg/kg Ipilimumab every three weeks for four doses intravenous
Interventions
NameTypeDescription
TilsotolimodDRUG9 doses of Tilsotolimod Intratumoral injection administered as a dose of 8mg at Week 0 Day 1 (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.
NivolumabDRUGSpecified dose on specified days.
IpilimumabDRUGSpecified dose on specified days.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Main Inclusion Criteria: 1. Subject must be willing and able to sign the informed consent and comply with study protocol. 2. Must be ≥ 18 years of age (males and females). 3. ≥ 1 lesion accessible for i.t. injection and biopsy(ies). 4. Eastern Cooperative Oncology Group (ECOG) performance status of...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT03865082studyFirstPostDate: changed