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Metastatic MelanomaPhase 3NCT05155254

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

A Phase 3 study testing IO102-IO103 and Pembrolizumab in people with Metastatic Melanoma and Unresectable Melanoma, run by IO Biotech at 112 sites in 16 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Melanoma, Unresectable Melanoma
What is being tested?
IO102-IO103 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
407 participants
Where
112 sitesin 16 countries
Study dates
17 May 2022to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • 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.

Who cannot join

  • 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.
  • Other protocol defined inclusion/exclusion criteria may apply.

Trial locations and contacts

112 sites in 16 countries.

112 sites in 16 countries

Germany18 sites

  • Universitatsklinikum Augsburg Medizincampus Sued

    Augsburg, 86179

  • Charite Universitaetsmedizin Berlin

    Berlin, 13353

  • St. Josef Hospital - Ruhr-Universitt Bochum

    Bochum, 44791

  • University Hospital Erlangen

    Erlangen, 90054

  • Universitaetsklinikum Essen

    Essen, 45147

  • University Hospital Frankfurt Theodor-Stern-Kai

    Frankfurt, 60590

  • Universitatsklinik fur Dermatologie und Venerologie der MLU Halle-Wittenberg

    Halle, 6120

  • Elbe Klinikum Buxtehude

    Hamburg, 22045

  • Nationales Centrum fr Tumorerkrankungen NCT

    Heidelberg, 69120

  • SLK-Kliniken Heilbronn GmbH

    Heilbronn, 74078

  • Universitaetsklinikum Schleswig-Holstein

    Kiel, 24105

  • Department of Dermatology University of Mainz

    Mainz, 55131

  • Universitatsmedizin Mannheim Dermatologie

    Mannheim, 68167

  • Mühlenkreiskliniken AöR, University Hospital Ruhr University Bochum Campus Minden

    Minden, 32429

  • LMU Muenchen

    München, 80337

  • Universitaetsklinikum Muenster

    Münster, 48149

  • Hospital Tubingen

    Tübingen, 72076

  • Universittsklinikum Wuerzburg

    Würzburg, 97080

Other trials in Germany

Spain16 sites

  • CH Universitario de A Coruña (CHUAC)

    A Coruña, 15006

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Instituto Oncologico Dr. Rosell IOR - Hospital Universitari Quiron Dexeus

    Barcelona, 8028

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

    Barcelona, 8916

  • Hospital Vall d'hebron

    Barcelona

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario Central de Asturias (HUCA)

    Oviedo, 33011

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Miguel Servet University Hospital

    Zaragoza, 50009

Other trials in Spain

France13 sites

  • Centre Hospitalier Universitaire de Besançon Jean Minjoz

    Besançon, 25000

  • Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre

    Bordeaux, 33075

  • Hopital Ambroise

    Boulogne-Billancourt, 92100

  • Centre Georges Francois Leclerc

    Dijon, 21079

  • Chu Grenoble - Hopital Albert Michallon

    La Tronche, 38700

  • Centre Hospitalier Universitaire de Lille

    Lille, 59000

  • Hôpital de La Timone

    Marseille, 13385

  • CHU de Nice Hpital de lArchet 2

    Nice, 6200

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Eugene Marquis

    Rennes, 35042

  • Institut de Cancérologie de L'Ouest

    Saint-Herblain, 44805

  • Centre Hospitalier de Valence (CHV)

    Valence, 26 953

  • Gustave Roussy

    Villejuif, 94805

Other trials in France

Italy13 sites

  • Clinica Oncologica, AOU Riuniti ancona

    Ancona, 60126

  • Centro di Riferimento Oncologico

    Aviano, 33081

  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

    Bari, 70124

  • IRCCS Ospedale San Raffaele

    Candiolo, 10060

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132

  • Istituto Romagnolo per lo Studio dei Tumori " DINO AMADORI"

    Meldola, 47014

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

  • Veneto Oncology Institute

    Padova, 35128

  • Ospedale S. Maria della Misericordia

    Perugia, 6156

  • IRCCS Istituti Fisioterapici Ospitalieri

    Roma, 144

  • Idi-Irccs

    Rome, 00167

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    Siena, 53100

Other trials in Italy

Australia8 sites

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 2640

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Sunshine Coast University Hospital

    Birtinya, 4575

  • Cairns Hospital

    Cairns, Queensland, 4870

  • Peter MacCallum Cancer Centre PMCC - East Melbourne

    Melbourne, 3052

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

Other trials in Australia

Turkey (Türkiye)7 sites

  • Adana City Education and Research Hospital

    Adana, 1060

  • Gulhane School of Medicine

    Ankara, 6010

  • Memorial Ankara Hospital

    Ankara, 6520

  • Akdeniz University Medical Faculty

    Antalya, 7059

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

    Bornova, 35100

  • Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty

    Istanbul, 34098

  • Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, 34722

Other trials in Turkey (Türkiye)

Israel6 sites

  • Emek Medical Center

    Afula

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

    Beersheba, 84101

  • Hadassah University Hospital

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center

    Tel Aviv

  • The Chaim Sheba Medical Center - The Ella Lemelbaum Institute for Immuno-Oncology

    Tel HaShomer, 5262100

Other trials in Israel

Netherlands6 sites

  • The Netherlands Cancer Institute

    Amsterdam, 1066

  • AMC Amsterdam, locatie VUMC

    Amsterdam, 1081

  • LUMC

    Leiden, 2300 RC

  • UMC Maastricht

    Maastricht, 6229HX

  • Erasmus MC

    Rotterdam, 1054 ZG

  • University Medical Center Utrecht

    Utrecht, 3584

Other trials in Netherlands

United States4 sites

  • Roswell Park Cancer Institute

    Buffalo, New York, 14221

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • VCU Massey Cancer Center

    Richmond, Virginia, 23219

Other trials in United States

Czechia4 sites

  • FNHK Klinika onkologie a radioterapie

    Hradec Králové, 500 05

  • Fakultni Nemocnice Olomouc

    Olomouc, 779 00

  • FN Ostrava

    Ostrava, 708 52

  • FNKV Department of Dermatology

    Prague, 10034

Other trials in Czechia

Denmark4 sites

  • Aalborg University Hospital

    Aalborg, 9000

  • Aarhus University Hospital

    Aarhus, 8200

  • Herlev og Gentofte Hospital

    Herlev, 2730

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

United Kingdom4 sites

  • Guy's Hospital

    London, SE1 9RT

  • Christie Hospital NHS Trust

    Manchester, M20 4BX

  • Christie Hospital NHS Trust

    Manchester, M20 4XB

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

Other trials in United Kingdom

Hungary3 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Bor, -Nemikortani es Onkodermatologiai Klinika

    Pécs, 7632

  • Hetenyi G Korhaz, Onkologiai Kozpont

    Szolnok, 5000

Other trials in Hungary

Belgium2 sites

  • Universitair Ziekenhuis Gent UZ Gent

    Ghent, Oost-Vlaanderen, 9000

  • AZ Nikolaas

    Sint-Niklaas, 9100

Other trials in Belgium

Poland2 sites

  • Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

    Poznan, 60-780

  • Maria Sklodowska-Curie National Research Institute of Oncology

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

South Africa2 sites

  • Cape Town Oncology Trials (Pty) Ltd.

    Cape Town, 7570

  • Mary Potter Oncology Centre Groenkloof

    Pretoria, 0181

Other trials in South Africa

About this study

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)

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.

Read more

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.

Being tested
IO102-IO103, Pembrolizumab
Keywords
Metastatic melanoma, Unresectable melanoma, Immunotherapy, Progression free survival, IO102-IO103, Pembrolizumab
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IO102-IO103Drug

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

  • PembrolizumabDrug

    Pembrolizumab administered intravenously

Study groups in NCT05155254
Study groupRoleWhat they receive
IO102-IO103 + pembrolizumabExperimentalIO102-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.
Receives: Drug: IO102-IO103; Drug: Pembrolizumab
pembrolizumabActive comparatorPembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment).
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Approximately 3.5 years

Secondary outcomes (9)

  1. Overall Response Rate (ORR)

    ORR defined as the percentage of patients achieving a confirmed PR or CR. ORR will be determined by an IRC in accordance with RECIST v1.1.

    Measured: Approximately 2.5 years

  2. Overall survival (OS)

    OS defined as the time from randomisation until death from any cause. months. This will be determined by an IRC in accordance with RECIST v1.1.

    Measured: Approximately 5.5 years

  3. Durable Objective response rate (DRR)

    DRR is defined as the percentage of patients achieving a PR or CR > 6 months. This will be determined by an IRC in accordance with RECIST v1.1.

    Measured: Approximately 3.5 years

  4. Complete response rate (CRR)

    Percentage of patients with a visit response of CR, which will be determined by the IRC in accordance with RECIST v1.1.

    Measured: Approximately 3.5 years

  5. Duration of response (DoR)

    DoR will be measured from the date of first observed objective response until disease progression or death (whichever is earlier) (based on IRC).

    Measured: Approximately 3.5 years

  6. Time to response (TTR)

    TTR is defined as the time from the date of randomization to the date of first observed PR or CR (based on IRC).

    Measured: Approximately 3.5 years

  7. Time to complete response (TTCR)

    TTCR is defined as the time from the date of randomization to the date of first observed CR (based on IRC).

    Measured: Approximately 3.5 years

  8. Disease control rate (DCR)

    DCR is defined as the percentage of patients achieving a PR or CR or SD (based on IRC).

    Measured: Approximately 3.5 years

  9. Incidence of e.g. AEs and SAEs (Safety and Tolerability)

    Incidence of AEs and SAEs, and treatment related AEs and SAEs. Incidence of AEs causing discontinuation of trial treatment.

    Measured: Approximately 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2021
  2. Study start17 May 2022
  3. Primary completion30 May 2025
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomised 1:1 to receive either dual-antigen IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone
Masking
None (open label)
Enrolment
407 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05155254
Sponsor's protocol ID
IO102-IO103-013 / KEYNOTE-D18
Other IDs
2021-004594-32
Status last verified
May 2025
First submitted
30 Nov 2021
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing IO102-IO103 and Pembrolizumab in people with Metastatic Melanoma and Unresectable Melanoma, run by IO Biotech at 112 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 112 sites in Germany, Spain, France, Italy, Australia and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Approximately 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05155254.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.

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