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Checkpoint Inhibitor

Tilsotolimod for Solid Tumors

Phase 2
Waitlist Available
Research Sponsored by Idera Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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).
Awards & highlights

Summary

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

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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).
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Demonstrate the efficacy of intratumoral tilsotolimod in combination with ipilimumab and nivolumab for each cohort
Duration of response
Secondary outcome measures
Safety and tolerability of the combination of tilsotolimod with nivolumab and ipilimumab

Trial Design

1Treatment groups
Experimental Treatment
Group I: IO Naive Subjects MSS CRCExperimental Treatment3 Interventions
8mg 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~3140
Tilsotolimod
2020
Completed Phase 1
~30
Nivolumab
2014
Completed Phase 3
~5220

Find a Location

Who is running the clinical trial?

Idera Pharmaceuticals, Inc.Lead Sponsor
14 Previous Clinical Trials
1,207 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,678 Previous Clinical Trials
4,125,615 Total Patients Enrolled
Idera Medical DirectorStudy DirectorIdera Pharmaceuticals, Inc.
3 Previous Clinical Trials
588 Total Patients Enrolled
~5 spots leftby Sep 2025
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