Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Idera Pharmaceuticals, Inc.
Study ID
NCT03865082
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tilsotolimod — DRUG
    9 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.
  • Nivolumab — DRUG
    Specified dose on specified days.
  • Ipilimumab — DRUG
    Specified dose on specified days.

Study Details

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

Key Dates

Start date
Oct 29, 2019
Status verified
Feb 2022
Primary completion
Mar 31, 2022
Completion
Apr 30, 2022

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IO Naive Subjects MSS CRC
    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

Primary Outcome Measure

Demonstrate the efficacy of intratumoral tilsotolimod in combination with ipilimumab and nivolumab for each cohort [ Time Frame: 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). ]

Locations (3)

FacilityCityStateZIPSite coordinators
Banner University Medical Center Tucson CampusTucsonArizona85719-
University of Southern California/ Hoag Hospital PresbyterianNewport BeachCalifornia92663-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Tucson, AZ

By research site
Banner University Medical Center Tucson Campus· Tucson, AZUniversity of Southern California/ Hoag Hospital Presbyterian· Newport Beach, CAMD Anderson Cancer Center· Houston, TX

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