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NCT05155254

PHASE3

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

Sponsor: IO Biotech

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

407

Start Date

2022-05-17

Completion Date

2027-09

Last Updated

2025-08-28

Healthy Volunteers

Conditions

Metastatic Melanoma Unresectable 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

Inclusion Criteria: 1. 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 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: 1. 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. 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. Other protocol defined inclusion/exclusion criteria may apply.

Locations (112)

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

Naples, Italy

Veneto Oncology Institute

Padova, 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 MaraÃ±on

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)