MedTrace Logo

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

NCT03445533 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 481

Last updated 2022-11-08

Study results available
· View outcomes & findings →

Summary

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

Conditions

Interventions

DRUG

Ipilimumab

Arm A: 4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.

DRUG

Tilsotolimod with Ipilimumab

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

Sponsors & Collaborators

Principal Investigators

  • Idera Medical Director · Idera Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2021-06-01
Completion
2021-06-01
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445533 on ClinicalTrials.gov