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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03445533
Other study ID # 2125-MEL-301
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date May 30, 2018
Est. completion date June 1, 2021

Study information

Verified date October 2022
Source Idera Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

A Phase 3 global, multi-center, open-label comparison of ipilimumab with and without intratumoral IMO-2125 in subjects with advanced melanoma who had confirmed disease progression while on anti-PD-1


Recruitment information / eligibility

Status Terminated
Enrollment 481
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subjects must be willing and able to sign the informed consent and comply with the study protocol. 2. Subjects must be =18 years of age. 3. Subjects must have histologically confirmed metastatic melanoma with measurable (by RECIST v1.1), stage III (lymph node or in transit lesions) or stage IVA, IVB, or IVC disease that is accessible for injection. 4. Patients must have confirmed progression during or after treatment with a PD-1 inhibitor (cannot be part of a bi-specific antibody) e.g. nivolumab or pembrolizumab. Confirmed progression is defined as: - Radiological progression (confirmed at least 4 weeks after the initial scan showing PD); or - (For progression based solely on worsening of non-target or new, non-measurable disease) confirmation by an additional scan at least 4 weeks after the initial scan unless it is accompanied by correlative symptoms. In addition, all the following must hold: 1. No intervening anti-cancer therapy between the last course of PD-1 inhibitor treatment and the first dose of study treatment is allowed except for local measures (e.g., surgical excision or biopsy, focal radiation therapy). 2. The interval between last PD-1 inhibitor and start of study treatment should be at least 21 days with no residual anti-PD-1-related immune toxicities in excess of Grade 1 severity. 3. If BRAF mutation status is unknown, before randomization the subject must have BRAF testing performed using an approved assay method. 4. Patients with BRAF-positive tumor(s) are eligible for the study if they received prior treatment with a BRAF inhibitor (alone of in combination with a MEK inhibitor) or declined targeted therapy. 5. Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status = 1. 6. Patients must meet the following laboratory criteria: 1. Absolute neutrophil count (ANC) = 1.5 x 10^9/L (1500/mm3) 2. Platelet count = 75 x 10^9/L (75,000/mm3) 3. Hemoglobin = 8.0 g/dL (4.96 mmol/L) 4. Serum creatinine = 1.5 x upper limit of normal (ULN) or calculated creatinine clearance = 60 mL/minute 5. Aspartate aminotransferase (AST) = 2.5 x ULN; alanine aminotransferase (ALT) = 2.5 x ULN; AST/ALT < 5 x ULN if liver involvement 6. Serum bilirubin = 1.5 x ULN, except in subjects with Gilbert's Syndrome who must have a total bilirubin < 3 mg/dL 7. Women of childbearing potential (WOCBP) and men must agree to use effective contraceptive methods from Screening throughout the study treatment period and until at least 90 days after the last dose of either ipilimumab or IMO-2125, whichever is later. 8. WOCBP must have a negative pregnancy test (serum or urine). Exclusion Criteria: 1. Ocular melanoma. 2. Prior therapy with a toll-like receptor (TLR) agonist, excluding topical agents. 3. Prior ipilimumab treatment with the exception of adjuvant treatment completed =6 months prior to enrollment 4. Systemic treatment with interferon (IFN)-a within the previous 6 months. 5. Known hypersensitivity to any oligodeoxynucleotide. 6. Active autoimmune disease requiring disease-modifying therapy at the time of Screening. 7. Subjects requiring systemic steroid therapy receiving >10 mg/day of prednisone (or equivalent) for the 2 weeks preceding start of study. 8. Subjects with another primary malignancy that has not been in remission for at least 3 years, with the exception of non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic). 9. Active systemic infections requiring antibiotics 10. Active hepatitis A, B, or C infection. 11. Known diagnosis of human immunodeficiency virus (HIV) infection. 12. Women who are pregnant or breastfeeding. 13. Prior severe reaction to treatment with a human antibody that cannot be managed with standard supportive measures. 14. Presence of known central nervous system, meningeal, or epidural metastatic disease. However, subjects with known brain metastases are allowed if the brain metastases are stable for =4 weeks before the first dose of study treatment. Stable is defined as neurological symptoms not present or resolved to baseline, no radiologic evidence of progression, and steroid requirement of prednisone =10 mg/day or equivalent 15. Impaired cardiac function or clinically significant cardiac disease.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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

Locations

Country Name City State
Australia University Hospital Geelong Geelong Victoria
Australia Greenslopes Private Hospital Greenslopes Queensland
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia Icon Cancer Center South Brisbane Queensland
Australia Gold Coast University Hospital Southport Queensland
Australia Queen Elizabeth Hospital Woodville South South Australia
Canada Tom Baker Cancer Centre Calgary Alberta
Canada Alberta Health Services Cross Cancer Institute Edmonton Alberta
Canada Princess Margaret Hopsital Toronto Ontario
Czechia Fakultni nemocnice Olomouc - Oncology clinic Olomouc
Czechia Dermatovenerologika Klinika Praha
Czechia Vseobecna fakultni nemocnice v Praze Praha
France CHU Amiens Picardie - Hopital Sud Amiens
France CHU - Clermont Ferrand Clermont-Ferrand Cedex
France CHU Dijon - Hôpital Mitterrand Dijon
France CHU de Grenoble La Tronche
France CHRU de Lille - Hôpital Claude Huriez Lille
France Centre Leon Berard Lyon Cedex 08
France CHU de Marseille - Hopital de la Timone Marseille
France Hopital Saint Louis Paris
France Centre Hospitalier Lyon Sud Pierre-Bénite
France CHRU Besançon - Jean Minjoz Rouen Cedex
France CHU Hopitaux de Rouen Rouen
France Institut Gustave Roussy Villejuif
Germany Klinikum Augsburg Augsburg
Germany Charite Universitaetsmedizin Berlin Berlin
Germany Elbe Kliniken Buxtehude
Germany Medizinische Hochschule Hannover - Klinik for Dermatologie, Allergologie und Venerologie Hannöver
Germany Universitaetsklinikum Heidelberg Universitaets-Hautklinik Heidelberg
Germany Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz Mainz
Germany Universitatsklinikum Regensburg Regensburg
Germany Universität Tübingen Tübingen
Germany Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universität Würzburg Würzburg
Italy Azienda Ospedale Policlinico di Bari Bari
Italy Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari Bari
Italy ASST degli Spedali Civili di Brescia Brescia
Italy IRCCS Azienda Ospedaliera Universitaria San Martino IST Genova
Italy Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori Meldola
Italy Istituto Europeo di Oncologia Milano
Italy Azienda Ospedaliero-Universitaria di Modena Modena
Italy Istituto Nazionale di Tumori IRCCS "Fondazione Sen. G. Pascale" Napoli
Italy Istituto Oncologico Veneto-I.R.C.C.S. Padova
Italy Azienda Ospedaliero Universitaria Pisana Pisa
Italy Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore Rome
Italy Azienda Ospedaliero Universitaria Senese Siena
Italy Universita di Torino Torino
Netherlands Leids Universitair Medisch Centrum Leiden
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Spain Hospital Universitario A Coruna A Coruña
Spain Hospital Germans Trias i Pujol Badalona
Spain Hospital Clinic Barcelona Barcelona
Spain Hospital Universitari Quiron Dexeus Barcelona Barcelona
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain Onkologikoa Donostia
Spain Hospital General Universitario Gregorio Maranon Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Universitario Virgen Macarena Sevilla
Spain Consorci Hospital General Universitari de Valencia Valencia
Sweden Skånes Universitetssjukhus i Lund Lund
Sweden Karolinska Universitetssjukhuset Solna
Sweden Centrallasarettet i Växjö Växjö
United Kingdom Bristol Haematology and Oncology Centre Bristol
United Kingdom Guy's Hospital London
United Kingdom Royal Marsden Foundation Trust London
United States University of Alabama at Birmingham (UAB) Birmingham Alabama
United States University of Cincinnati Health Cincinnati Ohio
United States The Cleveland Clinic Foundation Cleveland Ohio
United States The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James) Columbus Ohio
United States Inova Health Care Services Falls Church Virginia
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States MD Anderson Cancer Center Houston Texas
United States University of California, Los Angeles (UCLA) Los Angeles California
United States University of Southern California Los Angeles California
United States Mount Sinai Medical Center of Florida, Inc. Miami Beach Florida
United States University of Florida Health Cancer Center - Orlando Health Orlando Florida
United States The Valley Hospital Ridgewood New Jersey
United States Sutter Health Sacramento Sacramento California
United States University of California, San Diego (UCSD) - Moores Cancer Center San Diego California
United States Cancer Treatment Centers of America (CTCA) - Western Regional Medical Center Scottsdale Arizona
United States Stanford Cancer Center Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Idera Pharmaceuticals, Inc. Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome

Type Measure Description Time frame Safety issue
Primary Summary of Independent Reviewer-Assessed Objective Response Rate (ORR) by RECIST v1.1 The ORR for evaluable participants was calculated using the participant's best overall response (BOR).
Per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) for target lesions as assessed by MRI, CT or X-ray: Complete Response (CR) - disappearance of all target lesions; Partial Response (PR) - >=30% decrease from baseline of the sum of diameters of all target lesions; Stable Disease (SD) - does not qualify for CR, PR or Progression; Progressive Disease (PD) - 20% increase in the sum of diameters of target lesions.
The calculation is derived from measuring the diameter (mm) of the target lesion at baseline and comparing target lesion diameter (mm) at intervals during treatment and/or post-treatment. Based on the percent of tumor decrease or increase, the appropriate category is assigned.
Response is measured from the date of randomization, until disease progression, death, or start of new anti-cancer therapy (up to 36 months).
Primary Summary of Overall Survival Efficacy measured by overall survival (OS) was defined as the number of participants alive compared to the number of participants that died by treatment group. OS is measured from the date of randomization to the date of death from any cause (up to 36 months).
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