IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
An Open-label, Randomized, Phase 3 Clinical Trial of IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Patients With Previously Untreated, Unresectable, or Metastatic (Advanced) Melanoma (IO102-IO103-013 / MK3475-D18)
2 other identifiers
interventional
407
16 countries
112
Brief Summary
Phase 3, multicenter, international, open-label, randomized, 2-arm trial investigating the safety and efficacy of IO102-IO103 in combination with pembrolizumab as first-line treatment for patients with previously untreated unresectable or metastatic (advanced) melanoma. Patients will be stratified on the basis of the following factors; Disease stage: Stage III (unresectable) and IV M1a-b versus stage IV M1c-d and BRAFV600 mutation status: mutated vs wild type. All patients will receive pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment). Patients randomized to IO102-IO103 dual-antigen, immunotherapeutic arm will also be given IO102-IO103 Q3W with an additional dose given during the induction period on Day 8 of cycles 1 and 2. IO102 IO103 will thereafter be administered subcutaneous every 3 weeks during the maintenance period. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years of treatment). The primary objective is to investigate the efficacy of IO102-IO103 in combination with pembrolizumab (compared with pembrolizumab alone) in terms of progression free survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2022
Longer than P75 for phase_3
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2021
CompletedFirst Posted
Study publicly available on registry
December 13, 2021
CompletedStudy Start
First participant enrolled
May 17, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
ExpectedAugust 28, 2025
May 1, 2025
3 years
November 30, 2021
August 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
PFS defined as the time from randomization to the first documented disease progression ((based on Independent Review Committee in accordance with RECIST v1.1) or death from any cause.
Approximately 3.5 years
Secondary Outcomes (9)
Overall Response Rate (ORR)
Approximately 2.5 years
Overall survival (OS)
Approximately 5.5 years
Durable Objective response rate (DRR)
Approximately 3.5 years
Complete response rate (CRR)
Approximately 3.5 years
Duration of response (DoR)
Approximately 3.5 years
- +4 more secondary outcomes
Study Arms (2)
IO102-IO103 + pembrolizumab
EXPERIMENTALIO102-IO103 subcutaneous injections (85µg) every 3 weeks for a maximum 35 cycles (up to 2 years treatment). Additional dose given during the induction period on Day 8 of cycles 1 and 2. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years treatment). Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles.
pembrolizumab
ACTIVE COMPARATORPembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment).
Interventions
IO102-IO103 comprises IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103) emulsified with adjuvant (Montanide ISA 51 VG) administered subcutaneously
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed stage III (unresectable) or stage IV melanoma, as per American Joint Committee on Cancer 8th edition guidelines not amenable to local therapy
- Patients are treatment naive, that is, no previous systemic anticancer therapy for unresectable or metastatic melanoma. For clarification, the following patients are eligible:
- Patients with BRAFV600 mutation-positive melanoma are eligible if treatment naive and without rapidly progressive disease as per investigators assessment. Documented BRAF V600 mutation status must be available from all patients prior to trial entry.
- At least 1 measurable lesion according to response evaluation criteria for solid tumors (RECIST v1.1) and confirmed by IRC.
- Provision of archival (obtained within 3 months), or newly acquired biopsy tissue not previously irradiated, and blood at screening for biomarker assessments. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
You may not qualify if:
- Patients with known or suspected central nervous system (CNS) metastases or with the CNS as the only site of active disease are excluded with the following exception:
- Patients with controlled (stable) brain metastases will be allowed to enroll (subject to baseline magnetic resonance imaging (MRI) confirmation). Controlled (stable) brain metastases are defined as those with no radiographic progression for at least 4 weeks after radiation and/or surgical treatment at the time of signed informed consent. Patients must have been off steroids for at least 2 weeks before signed informed consent and have no new or progressive neurological signs and symptoms.
- Patient has received previous radiotherapy within 2 weeks of start of trial treatment (visit 2). Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
- Patients with BRAFV600-positive disease who are experiencing rapidly progressing disease and/or have received standard first-line therapy with BRAF and/or MEK inhibitor for unresectable or metastatic disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- IO Biotechlead
- Syneos Healthcollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (112)
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763, United States
Orlando Health Cancer Institute
Orlando, Florida, 32806, United States
Roswell Park Cancer Institute
Buffalo, New York, 14221, United States
VCU Massey Cancer Center
Richmond, Virginia, 23219, United States
Border Medical Oncology Research Unit
Albury, New South Wales, 2640, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500, Australia
Cairns Hospital
Cairns, Queensland, 4870, Australia
Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011, Australia
Sunshine Coast University Hospital
Birtinya, 4575, Australia
Peter MacCallum Cancer Centre PMCC - East Melbourne
Melbourne, 3052, Australia
Universitair Ziekenhuis Gent UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
AZ Nikolaas
Sint-Niklaas, 9100, Belgium
FNHK Klinika onkologie a radioterapie
Hradec Králové, 500 05, Czechia
Fakultni Nemocnice Olomouc
Olomouc, 779 00, Czechia
FN Ostrava
Ostrava, 708 52, Czechia
FNKV Department of Dermatology
Prague, 10034, Czechia
Aalborg University Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital
Aarhus, 8200, Denmark
Herlev og Gentofte Hospital
Herlev, 2730, Denmark
Odense University Hospital
Odense, 5000, Denmark
Centre Hospitalier Universitaire de Besançon Jean Minjoz
Besançon, 25000, France
Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre
Bordeaux, 33075, France
Hopital Ambroise
Boulogne-Billancourt, 92100, France
Centre Georges Francois Leclerc
Dijon, 21079, France
Chu Grenoble - Hopital Albert Michallon
La Tronche, 38700, France
Centre Hospitalier Universitaire de Lille
Lille, 59000, France
Hôpital de La Timone
Marseille, 13385, France
CHU de Nice Hpital de lArchet 2
Nice, 6200, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Eugene Marquis
Rennes, 35042, France
Institut de Cancérologie de L'Ouest
Saint-Herblain, 44805, France
Centre Hospitalier de Valence (CHV)
Valence, 26 953, France
Gustave Roussy
Villejuif, 94805, France
Universitatsklinikum Augsburg Medizincampus Sued
Augsburg, 86179, Germany
Charite Universitaetsmedizin Berlin
Berlin, 13353, Germany
St. Josef Hospital - Ruhr-Universitt Bochum
Bochum, 44791, Germany
University Hospital Erlangen
Erlangen, 90054, Germany
Universitaetsklinikum Essen
Essen, 45147, Germany
University Hospital Frankfurt Theodor-Stern-Kai
Frankfurt, 60590, Germany
Universitatsklinik fur Dermatologie und Venerologie der MLU Halle-Wittenberg
Halle, 6120, Germany
Elbe Klinikum Buxtehude
Hamburg, 22045, Germany
Nationales Centrum fr Tumorerkrankungen NCT
Heidelberg, 69120, Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, 74078, Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Department of Dermatology University of Mainz
Mainz, 55131, Germany
Universitatsmedizin Mannheim Dermatologie
Mannheim, 68167, Germany
Mühlenkreiskliniken AöR, University Hospital Ruhr University Bochum Campus Minden
Minden, 32429, Germany
LMU Muenchen
München, 80337, Germany
Universitaetsklinikum Muenster
Münster, 48149, Germany
Hospital Tubingen
Tübingen, 72076, Germany
Universittsklinikum Wuerzburg
Würzburg, 97080, Germany
Orszagos Onkologiai Intezet
Budapest, 1122, Hungary
Bor, -Nemikortani es Onkodermatologiai Klinika
Pécs, 7632, Hungary
Hetenyi G Korhaz, Onkologiai Kozpont
Szolnok, 5000, Hungary
Emek Medical Center
Afula, Israel
Ben-Gurion University of the Negev - Soroka University Medical Center - Soroka Clinical Research Center
Beersheba, 84101, Israel
Hadassah University Hospital
Jerusalem, 91120, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
The Chaim Sheba Medical Center - The Ella Lemelbaum Institute for Immuno-Oncology
Tel Litwinsky, 5262100, Israel
Clinica Oncologica, AOU Riuniti ancona
Ancona, 60126, Italy
Centro di Riferimento Oncologico
Aviano, 33081, Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, 70124, Italy
IRCCS Ospedale San Raffaele
Candiolo, 10060, Italy
IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
Istituto Romagnolo per lo Studio dei Tumori " DINO AMADORI"
Meldola, 47014, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, 20133, Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, 80131, Italy
Veneto Oncology Institute
Padua, 35128, Italy
Ospedale S. Maria della Misericordia
Perugia, 6156, Italy
IRCCS Istituti Fisioterapici Ospitalieri
Roma, 144, Italy
Idi-Irccs
Rome, 00167, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, 53100, Italy
The Netherlands Cancer Institute
Amsterdam, 1066, Netherlands
AMC Amsterdam, locatie VUMC
Amsterdam, 1081, Netherlands
LUMC
Leiden, 2300 RC, Netherlands
UMC Maastricht
Maastricht, 6229HX, Netherlands
Erasmus MC
Rotterdam, 1054 ZG, Netherlands
University Medical Center Utrecht
Utrecht, 3584, Netherlands
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Masovian Voivodeship, 02-781, Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan, 60-780, Poland
Cape Town Oncology Trials (Pty) Ltd.
Cape Town, 7570, South Africa
Mary Potter Oncology Centre Groenkloof
Pretoria, 0181, South Africa
Hospital Universitario Virgen Macarena
Seville, Andalusia, 41009, Spain
CH Universitario de A Coruña (CHUAC)
A Coruña, 15006, Spain
Hospital Clinic i Provincial
Barcelona, 08036, Spain
Instituto Oncologico Dr. Rosell IOR - Hospital Universitari Quiron Dexeus
Barcelona, 8028, Spain
Hospital Universitari Germans Trias i Pujol HUGTP, ICO-Badalona
Barcelona, 8916, Spain
Hospital Vall d'hebron
Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, 33011, Spain
Clinica Universidad de Navarra
Pamplona, 31008, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Miguel Servet University Hospital
Zaragoza, 50009, Spain
Adana City Education and Research Hospital
Adana, 1060, Turkey (Türkiye)
Gulhane School of Medicine
Ankara, 6010, Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, 6520, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, 7059, Turkey (Türkiye)
Ege university Faculty of Medicine, T. Aktas Oncology Hospital, Bornova
Bornova, 35100, Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, 34722, Turkey (Türkiye)
Guy's Hospital
London, SE1 9RT, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4BX, United Kingdom
Christie Hospital NHS Trust
Manchester, M20 4XB, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 7LE, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inge Marie Svane, MD, Prof
Institut for Klinisk Medicin, Herlev-Gentofte Hospital; Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2021
First Posted
December 13, 2021
Study Start
May 17, 2022
Primary Completion
May 30, 2025
Study Completion (Estimated)
September 1, 2027
Last Updated
August 28, 2025
Record last verified: 2025-05