IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
NCT ID: NCT05155254
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
407 participants
INTERVENTIONAL
2022-05-17
2027-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IO102-IO103 + pembrolizumab
IO102-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.
IO102-IO103
IO102-IO103 comprises IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103) emulsified with adjuvant (Montanide ISA 51 VG) administered subcutaneously
Pembrolizumab
Pembrolizumab administered intravenously
pembrolizumab
Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment).
Pembrolizumab
Pembrolizumab administered intravenously
Interventions
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IO102-IO103
IO102-IO103 comprises IDO peptide antigen (IO102) and PD-L1 peptide antigen (IO103) emulsified with adjuvant (Montanide ISA 51 VG) administered subcutaneously
Pembrolizumab
Pembrolizumab administered intravenously
Eligibility Criteria
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Inclusion Criteria
2. Patients are treatment naive, that is, no previous systemic anticancer therapy for unresectable or metastatic melanoma. For clarification, the following patients are eligible:
1. 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.
2. Patients who have received previous adjuvant and/or neoadjuvant therapy with targeted therapy or immune therapy are eligible if administered the last dose at least 6 months before inclusion in this trial (randomization), and if relapse did not occur during active treatment or within 6 months of treatment discontinuation.
3. At least 1 measurable lesion according to response evaluation criteria for solid tumors (RECIST v1.1) and confirmed by IRC.
4. 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.
Exclusion Criteria
• 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.
2. 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.
3. 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.
18 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Merck Sharp & Dohme LLC
INDUSTRY
IO Biotech
INDUSTRY
Responsible Party
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Principal Investigators
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Inge Marie Svane, MD, Prof
Role: PRINCIPAL_INVESTIGATOR
Institut for Klinisk Medicin, Herlev-Gentofte Hospital; Denmark
Locations
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Mid Florida Hematology and Oncology Center
Orange City, Florida, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
VCU Massey Cancer Center
Richmond, Virginia, United States
Border Medical Oncology Research Unit
Albury, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Cairns Hospital
Cairns, Queensland, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Sunshine Coast University Hospital
Birtinya, , Australia
Peter MacCallum Cancer Centre PMCC - East Melbourne
Melbourne, , Australia
Universitair Ziekenhuis Gent UZ Gent
Ghent, Oost-Vlaanderen, Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
FNHK Klinika onkologie a radioterapie
Hradec Králové, , Czechia
Fakultni Nemocnice Olomouc
Olomouc, , Czechia
FN Ostrava
Ostrava, , Czechia
FNKV Department of Dermatology
Prague, , Czechia
Aalborg University Hospital
Aalborg, , Denmark
Aarhus University Hospital
Aarhus, , Denmark
Herlev og Gentofte Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Centre Hospitalier Universitaire de Besançon Jean Minjoz
Besançon, , France
Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre
Bordeaux, , France
Hopital Ambroise
Boulogne-Billancourt, , France
Centre Georges Francois Leclerc
Dijon, , France
Chu Grenoble - Hopital Albert Michallon
La Tronche, , France
Centre Hospitalier Universitaire de Lille
Lille, , France
Hôpital de La Timone
Marseille, , France
CHU de Nice Hpital de lArchet 2
Nice, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Centre Eugene Marquis
Rennes, , France
Institut de Cancérologie de L'Ouest
Saint-Herblain, , France
Centre Hospitalier de Valence (CHV)
Valence, , France
Gustave Roussy
Villejuif, , France
Universitatsklinikum Augsburg Medizincampus Sued
Augsburg, , Germany
Charite Universitaetsmedizin Berlin
Berlin, , Germany
St. Josef Hospital - Ruhr-Universitt Bochum
Bochum, , Germany
University Hospital Erlangen
Erlangen, , Germany
Universitaetsklinikum Essen
Essen, , Germany
University Hospital Frankfurt Theodor-Stern-Kai
Frankfurt, , Germany
Universitatsklinik fur Dermatologie und Venerologie der MLU Halle-Wittenberg
Halle, , Germany
Elbe Klinikum Buxtehude
Hamburg, , Germany
Nationales Centrum fr Tumorerkrankungen NCT
Heidelberg, , Germany
SLK-Kliniken Heilbronn GmbH
Heilbronn, , Germany
Universitaetsklinikum Schleswig-Holstein
Kiel, , Germany
Department of Dermatology University of Mainz
Mainz, , Germany
Universitatsmedizin Mannheim Dermatologie
Mannheim, , Germany
Mühlenkreiskliniken AöR, University Hospital Ruhr University Bochum Campus Minden
Minden, , Germany
LMU Muenchen
München, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Hospital Tubingen
Tübingen, , Germany
Universittsklinikum Wuerzburg
Würzburg, , Germany
Orszagos Onkologiai Intezet
Budapest, , Hungary
Bor, -Nemikortani es Onkodermatologiai Klinika
Pécs, , Hungary
Hetenyi G Korhaz, Onkologiai Kozpont
Szolnok, , Hungary
Emek Medical Center
Afula, , Israel
Ben-Gurion University of the Negev - Soroka University Medical Center - Soroka Clinical Research Center
Beersheba, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
The Chaim Sheba Medical Center - The Ella Lemelbaum Institute for Immuno-Oncology
Tel Litwinsky, , Israel
Clinica Oncologica, AOU Riuniti ancona
Ancona, , Italy
Centro di Riferimento Oncologico
Aviano, , Italy
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, , Italy
IRCCS Ospedale San Raffaele
Candiolo, , Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
Istituto Romagnolo per lo Studio dei Tumori " DINO AMADORI"
Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, , Italy
Veneto Oncology Institute
Padua, , Italy
Ospedale S. Maria della Misericordia
Perugia, , Italy
IRCCS Istituti Fisioterapici Ospitalieri
Roma, , Italy
Idi-Irccs
Rome, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, , Italy
The Netherlands Cancer Institute
Amsterdam, , Netherlands
AMC Amsterdam, locatie VUMC
Amsterdam, , Netherlands
LUMC
Leiden, , Netherlands
UMC Maastricht
Maastricht, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Masovian Voivodeship, Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan, , Poland
Cape Town Oncology Trials (Pty) Ltd.
Cape Town, , South Africa
Mary Potter Oncology Centre Groenkloof
Pretoria, , South Africa
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain
CH Universitario de A Coruña (CHUAC)
A Coruña, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Instituto Oncologico Dr. Rosell IOR - Hospital Universitari Quiron Dexeus
Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol HUGTP, ICO-Badalona
Barcelona, , Spain
Hospital Vall d'hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Clinica Universidad de Navarra
Madrid, , Spain
Hospital Universitario Ramon y Cajal
Madrid, , Spain
Hospital Universitario HM Sanchinarro
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitario Central de Asturias (HUCA)
Oviedo, , Spain
Clinica Universidad de Navarra
Pamplona, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Miguel Servet University Hospital
Zaragoza, , Spain
Adana City Education and Research Hospital
Adana, , Turkey (Türkiye)
Gulhane School of Medicine
Ankara, , Turkey (Türkiye)
Memorial Ankara Hospital
Ankara, , Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, , Turkey (Türkiye)
Ege university Faculty of Medicine, T. Aktas Oncology Hospital, Bornova
Bornova, , Turkey (Türkiye)
Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
Guy's Hospital
London, , United Kingdom
Christie Hospital NHS Trust
Manchester, , United Kingdom
Christie Hospital NHS Trust
Manchester, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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Other Identifiers
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2021-004594-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
IO102-IO103-013 / KEYNOTE-D18
Identifier Type: -
Identifier Source: org_study_id
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