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

PHASE3TerminatedINTERVENTIONAL
Enrollment

481

Participants

Timeline

Start Date

May 30, 2018

Primary Completion Date

June 1, 2021

Study Completion Date

June 1, 2021

Conditions
Metastatic Melanoma
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

Trial Locations (80)

3220

University Hospital Geelong, Geelong

4101

Icon Cancer Center, South Brisbane

4120

Greenslopes Private Hospital, Greenslopes

4215

Gold Coast University Hospital, Southport

5011

Queen Elizabeth Hospital, Woodville South

6150

Fiona Stanley Hospital, Murdoch

10034

Vseobecna fakultni nemocnice v Praze, Prague

10117

Charite Universitaetsmedizin Berlin, Berlin

10126

Universita di Torino, Torino

13385

CHU de Marseille - Hopital de la Timone, Marseille

15006

Hospital Universitario A Coruna, A Coruña

16132

IRCCS Azienda Ospedaliera Universitaria San Martino IST, Genova

17164

Karolinska Universitetssjukhuset, Solna

20014

Onkologikoa, Donostia / San Sebastian

20141

Istituto Europeo di Oncologia, Milan

21000

CHU Dijon - Hôpital Mitterrand, Dijon

21614

Elbe Kliniken, Buxtehude

22042

Inova Health Care Services, Falls Church

25030

CHRU Besançon - Jean Minjoz, Rouen

25123

ASST degli Spedali Civili di Brescia, Brescia

28007

Hospital General Universitario Gregorio Maranon, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

30625

Medizinische Hochschule Hannover - Klinik for Dermatologie, Allergologie und Venerologie, Hannover

32806

University of Florida Health Cancer Center - Orlando Health, Orlando

33140

Mount Sinai Medical Center of Florida, Inc., Miami Beach

35128

Istituto Oncologico Veneto-I.R.C.C.S., Padua

35294

University of Alabama at Birmingham (UAB), Birmingham

38700

CHU de Grenoble, La Tronche

41009

Hospital Universitario Virgen Macarena, Seville

41124

Azienda Ospedaliero-Universitaria di Modena, Modena

43221

The Ohio State University Comprehensive Cancer Center - Arthur G. James Cancer Hospital and Richard J. Solovev Research Institute (OSUCCC - James), Columbus

44195

The Cleveland Clinic Foundation, Cleveland

45219

University of Cincinnati Health, Cincinnati

46014

Consorci Hospital General Universitari de Valencia, Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

53100

Azienda Ospedaliero Universitaria Senese, Siena

55131

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz, Mainz

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

59037

CHRU de Lille - Hôpital Claude Huriez, Lille

63003

CHU - Clermont Ferrand, Clermont-Ferrand

69120

Universitaetsklinikum Heidelberg Universitaets-Hautklinik, Heidelberg

69373

Centre Leon Berard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70124

Azienda Ospedale Policlinico di Bari, Bari

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari, Bari

72076

Universität Tübingen, Tübingen

75010

Hopital Saint Louis, Paris

76031

CHU Hopitaux de Rouen, Rouen

77030

MD Anderson Cancer Center, Houston

80054

CHU Amiens Picardie - Hopital Sud, Amiens

80131

"Istituto Nazionale di Tumori IRCCS Fondazione Sen. G. Pascale", Napoli

85234

Banner MD Anderson Cancer Center, Gilbert

85338

Cancer Treatment Centers of America (CTCA) - Western Regional Medical Center, Scottsdale

86179

Klinikum Augsburg, Augsburg

90033

University of Southern California, Los Angeles

90095

University of California, Los Angeles (UCLA), Los Angeles

92093

University of California, San Diego (UCSD) - Moores Cancer Center, San Diego

93053

Universitatsklinikum Regensburg, Regensburg

94305

Stanford Cancer Center, Stanford

94805

Institut Gustave Roussy, Villejuif

95816

Sutter Health Sacramento, Sacramento

97080

Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Universität Würzburg, Würzburg

07450

The Valley Hospital, Ridgewood

T2N 4N2

Tom Baker Cancer Centre, Calgary

T6G 1Z2

Alberta Health Services Cross Cancer Institute, Edmonton

M5G 2M9

Princess Margaret Hopsital, Toronto

779 00

Fakultni nemocnice Olomouc - Oncology clinic, Olomouc

100 34

Dermatovenerologika Klinika, Prague

00168

Fondazione Policlinico Universitario A. Gemelli - Universita Cattolica del Sacro Cuore, Rome

2333 ZA

Leids Universitair Medisch Centrum, Leiden

3584CX

Universitair Medisch Centrum Utrecht, Utrecht

08916

Hospital Germans Trias i Pujol, Badalona

08028

Hospital Universitari Quiron Dexeus Barcelona, Barcelona

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinic Barcelona, Barcelona

221 85

Skånes Universitetssjukhus i Lund, Lund

351 85

Centrallasarettet i Växjö, Vaxjo

BS2 8ED

Bristol Haematology and Oncology Centre, Bristol

SE1 9RT

Guy's Hospital, London

SW3 6JJ

Royal Marsden Foundation Trust, London

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Idera Pharmaceuticals, Inc.

INDUSTRY

NCT03445533 - A Study of Tilsotolimod in Combo With Ipilimumab vs Ipilimumab Alone in Subjects With Anti-PD-1 Refractory Melanoma | Biotech Hunter | Biotech Hunter