A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Idera Pharmaceuticals, Inc.
Study ID
NCT03445533
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Ipilimumab — DRUG
    Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.
  • Tilsotolimod with Ipilimumab — DRUG
    IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24. WITH (Arm B): Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11. in combination with tilsotolimod

Study Details

A Phase 3 comparison of ipilimumab with and without IMO-2125 in advanced melanoma

Key Dates

Start date
May 30, 2018
Status verified
Oct 2022
Primary completion
Jun 1, 2021
Completion
Jun 1, 2021

Study Design

Enrollment
481 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: ipilimumab
    ipilimumab 3 mg/kg intravenous
  • Experimental: Arm B: IMO-2125 plus ipilimumab
    IMO-2125 by intratumoral injection plus ipilimumab 3 mg/kg intravenous

Primary Outcome Measure

Summary of Independent Reviewer-Assessed Objective Response Rate (ORR) by RECIST v1.1 [ Time Frame: Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months). ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham (UAB)BirminghamAlabama35294-
Banner MD Anderson Cancer CenterGilbertArizona85234-
Cancer Treatment Centers of America (CTCA) - Western Regional Medical CenterScottsdaleArizona85338-
University of California, Los Angeles (UCLA)Los AngelesCalifornia90095-
University of Southern CaliforniaLos AngelesCalifornia90033-
Sutter Health SacramentoSacramentoCalifornia95816-
University of California, San Diego (UCSD) - Moores Cancer CenterSan DiegoCalifornia92093-
Stanford Cancer CenterStanfordCalifornia94305-
Mount Sinai Medical Center of Florida, Inc.Miami BeachFlorida33140-
University of Florida Health Cancer Center - Orlando HealthOrlandoFlorida32806-
The Valley HospitalRidgewoodNew Jersey07450-
University of Cincinnati HealthCincinnatiOhio45219-
The Cleveland Clinic FoundationClevelandOhio44195-
The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James)ColumbusOhio43221-
MD Anderson Cancer CenterHoustonTexas77030-
Inova Health Care ServicesFalls ChurchVirginia22042-

Find similar trials in Birmingham, AL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Alabama at Birmingham (UAB)· Birmingham, ALBanner MD Anderson Cancer Center· Gilbert, AZCancer Treatment Centers of America (CTCA) - Western Regional Medical Center· Scottsdale, AZUniversity of California, Los Angeles (UCLA)· Los Angeles, CAUniversity of Southern California· Los Angeles, CASutter Health Sacramento· Sacramento, CA

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