IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

May 17, 2022

Primary Completion Date

May 30, 2025

Study Completion Date

September 30, 2027

Conditions
Metastatic MelanomaUnresectable Melanoma
Interventions
DRUG

IO102-IO103

IO102-IO103 comprises IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103) emulsified with adjuvant (Montanide ISA 51 VG) administered subcutaneously

DRUG

Pembrolizumab

Pembrolizumab administered intravenously

Trial Locations (112)

144

IRCCS Istituti Fisioterapici Ospitalieri, Roma

1060

Adana City Education and Research Hospital, Adana

1066

The Netherlands Cancer Institute, Amsterdam

1081

AMC Amsterdam, locatie VUMC, Amsterdam

1122

Orszagos Onkologiai Intezet, Budapest

2145

Westmead Hospital, Westmead

2500

Southern Medical Day Care Centre, Wollongong

2640

Border Medical Oncology Research Unit, Albury

2730

Herlev og Gentofte Hospital, Herlev

3052

Peter MacCallum Cancer Centre PMCC - East Melbourne, Melbourne

3584

University Medical Center Utrecht, Utrecht

4575

Sunshine Coast University Hospital, Birtinya

4870

Cairns Hospital, Cairns

5000

Odense University Hospital, Odense

Hetenyi G Korhaz, Onkologiai Kozpont, Szolnok

5011

The Queen Elizabeth Hospital, Woodville South

5042

Flinders Medical Centre, Bedford Park

6010

Gulhane School of Medicine, Ankara

6120

Universitatsklinik fur Dermatologie und Venerologie der MLU Halle-Wittenberg, Halle

6156

Ospedale S. Maria della Misericordia, Perugia

6200

CHU de Nice Hpital de lArchet 2, Nice

6520

Memorial Ankara Hospital, Ankara

7059

Akdeniz University Medical Faculty, Antalya

7570

Cape Town Oncology Trials (Pty) Ltd., Cape Town

7632

Bor, -Nemikortani es Onkodermatologiai Klinika, Pécs

8028

Instituto Oncologico Dr. Rosell IOR - Hospital Universitari Quiron Dexeus, Barcelona

8200

Aarhus University Hospital, Aarhus

8916

Hospital Universitari Germans Trias i Pujol HUGTP, ICO-Badalona, Barcelona

9000

Universitair Ziekenhuis Gent UZ Gent, Ghent

Aalborg University Hospital, Aalborg

9100

AZ Nikolaas, Sint-Niklaas

10034

FNKV Department of Dermatology, Prague

10060

IRCCS Ospedale San Raffaele, Candiolo

13353

Charite Universitaetsmedizin Berlin, Berlin

13385

Hôpital de La Timone, Marseille

14221

Roswell Park Cancer Institute, Buffalo

15006

CH Universitario de A Coruña (CHUAC), A Coruña

16132

IRCCS Ospedale Policlinico San Martino, Genova

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

21079

Centre Georges Francois Leclerc, Dijon

22045

Elbe Klinikum Buxtehude, Hamburg

23219

VCU Massey Cancer Center, Richmond

24105

Universitaetsklinikum Schleswig-Holstein, Kiel

25000

Centre Hospitalier Universitaire de Besançon Jean Minjoz, Besançon

28007

Hospital General Universitario Gregorio Marañon, Madrid

28027

Clinica Universidad de Navarra, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

28050

Hospital Universitario HM Sanchinarro, Madrid

29010

Hospital Regional Universitario de Malaga, Málaga

31008

Clinica Universidad de Navarra, Pamplona

32429

Mühlenkreiskliniken AöR, University Hospital Ruhr University Bochum Campus Minden, Minden

32763

Mid Florida Hematology and Oncology Center, Orange City

32806

Orlando Health Cancer Institute, Orlando

33011

Hospital Universitario Central de Asturias (HUCA), Oviedo

33075

Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre, Bordeaux

33081

Centro di Riferimento Oncologico, Aviano

34098

Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty, Istanbul

34722

Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi, Istanbul

35042

Centre Eugene Marquis, Rennes

35100

Ege university Faculty of Medicine, T. Aktas Oncology Hospital, Bornova, Bornova

35128

Veneto Oncology Institute, Padua

38700

Chu Grenoble - Hopital Albert Michallon, La Tronche

41009

Hospital Universitario Virgen Macarena, Seville

44791

St. Josef Hospital - Ruhr-Universitt Bochum, Bochum

44805

Institut de Cancérologie de L'Ouest, Saint-Herblain

45147

Universitaetsklinikum Essen, Essen

46014

Hospital General Universitario de Valencia, Valencia

46026

Hospital Universitari i Politecnic La Fe, Valencia

47014

"Istituto Romagnolo per lo Studio dei Tumori DINO AMADORI", Meldola

48149

Universitaetsklinikum Muenster, Münster

50009

Miguel Servet University Hospital, Zaragoza

53100

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte, Siena

55131

Department of Dermatology University of Mainz, Mainz

59000

Centre Hospitalier Universitaire de Lille, Lille

60126

Clinica Oncologica, AOU Riuniti ancona, Ancona

60590

University Hospital Frankfurt Theodor-Stern-Kai, Frankfurt

68167

Universitatsmedizin Mannheim Dermatologie, Mannheim

69120

Nationales Centrum fr Tumorerkrankungen NCT, Heidelberg

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

70124

Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari, Bari

72076

Hospital Tubingen, Tübingen

74078

SLK-Kliniken Heilbronn GmbH, Heilbronn

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli

80337

LMU Muenchen, München

84101

Ben-Gurion University of the Negev - Soroka University Medical Center - Soroka Clinical Research Center, Beersheba

86179

Universitatsklinikum Augsburg Medizincampus Sued, Augsburg

90054

University Hospital Erlangen, Erlangen

91120

Hadassah University Hospital, Jerusalem

92100

Hopital Ambroise, Boulogne-Billancourt

94805

Gustave Roussy, Villejuif

97080

Universittsklinikum Wuerzburg, Würzburg

4941492

Rabin Medical Center, Petah Tikva

5262100

The Chaim Sheba Medical Center - The Ella Lemelbaum Institute for Immuno-Oncology, Tel Litwinsky

500 05

FNHK Klinika onkologie a radioterapie, Hradec Králové

779 00

Fakultni Nemocnice Olomouc, Olomouc

708 52

FN Ostrava, Ostrava

26 953

Centre Hospitalier de Valence (CHV), Valence

Unknown

Emek Medical Center, Afula

Tel Aviv Sourasky Medical Center, Tel Aviv

Hospital Vall d'hebron, Barcelona

00167

Idi-Irccs, Rome

2300 RC

LUMC, Leiden

6229HX

UMC Maastricht, Maastricht

1054 ZG

Erasmus MC, Rotterdam

02-781

Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw

60-780

Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu, Poznan

0181

Mary Potter Oncology Centre Groenkloof, Pretoria

08036

Hospital Clinic i Provincial, Barcelona

SE1 9RT

Guy's Hospital, London

M20 4BX

Christie Hospital NHS Trust, Manchester

M20 4XB

Christie Hospital NHS Trust, Manchester

OX3 7LE

Oxford University Hospitals NHS Foundation Trust, Oxford

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

IO Biotech

INDUSTRY

NCT05155254 - IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) | Biotech Hunter | Biotech Hunter