A Phase 2 Study to Assess the Safety and Efficacy of IMO-2125 With 8 mg Ipilimumab in Patients With Metastatic Melanoma

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Idera Pharmaceuticals, Inc.
Study ID
NCT02644967
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • IMO-2125 — DRUG
    Drug: IMO-2125 Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.
  • Ipilimumab — DRUG
    4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.

Study Details

The goal of the Phase 1 study was to find the recommended Phase 2 dose of the study drug IMO-2125 (tilsotolimod) that can be given in combination with ipilimumab (ipi) or pembrolizumab (pembro) to participants with metastatic melanoma and assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity when administered in combination with ipilimumab or pembrolizumab.

Key Dates

Start date
Dec 31, 2015
Status verified
Jul 2022
Primary completion
Feb 29, 2020
Completion
May 31, 2021

Study Design

Enrollment
53 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 2, 8 mg Tilso/Ipi
    IMO-2125 intratumoral injection plus ipilimumab

Primary Outcome Measure

Phase 2: Number of Participants With Objective Response Rate (ORR) Using RECIST v1.1 [ Time Frame: 33 weeks (29 weeks of treatment, 4 weeks follow up) ]

Locations (10)

FacilityCityStateZIPSite coordinators
The University of Arizona Cancer CenterTucsonArizona85719-
Moffitt Cancer Center Research InstituteTampaFlorida33612-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
University of Kansas Cancer CenterWestwoodKansas66205-
Roswell Park Cancer InstituteBuffaloNew York14263-
Icahn School Of Medicine at Mount SinaiNew YorkNew York10029-
Gabrail Cancer CenterCantonOhio44718-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
MD Anderson Cancer CenterHoustonTexas77030-
University of Utah- Huntsman Cancer InstituteSalt Lake CityUtah84112-

Find similar trials in Tucson, AZ

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The University of Arizona Cancer Center· Tucson, AZMoffitt Cancer Center Research Institute· Tampa, FLUniversity of Iowa Hospitals and Clinics· Iowa City, IAUniversity of Kansas Cancer Center· Westwood, KSRoswell Park Cancer Institute· Buffalo, NYIcahn School Of Medicine at Mount Sinai· New York, NY

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