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IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
NCT05155254 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG IO102-IO103
Study Locations (20)
Other
- Sunshine Coast University Hospital — Birtinya
- Peter MacCallum Cancer Centre PMCC - East Melbourne — Melbourne
- AZ Nikolaas — Sint-Niklaas
- FNHK Klinika onkologie a radioterapie — Hradec Králové
- Fakultni Nemocnice Olomouc — Olomouc
- FN Ostrava — Ostrava
- FNKV Department of Dermatology — Prague
- Aalborg University Hospital — Aalborg
- Aarhus University Hospital — Aarhus
New South Wales
- Border Medical Oncology Research Unit — Albury
- Westmead Hospital — Westmead
- Southern Medical Day Care Centre — Wollongong
Florida
- Mid Florida Hematology and Oncology Center — Orange City
- Orlando Health Cancer Institute — Orlando
South Australia
- Flinders Medical Centre — Bedford Park
- The Queen Elizabeth Hospital — Woodville South
New York
- Roswell Park Cancer Institute — Buffalo
Virginia
- VCU Massey Cancer Center — Richmond
Queensland
- Cairns Hospital — Cairns
Oost-Vlaanderen
- Universitair Ziekenhuis Gent UZ Gent — Ghent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2022-05-17 |
| Est. Completion | 2027-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05155254
The ClinicalTrials.gov registry entry for NCT05155254 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 407 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IO Biotech, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05155254 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, New South Wales, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05155254 about?
NCT05155254 is a clinical study titled "IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-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 ...
What is the current status of trial NCT05155254?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 407 participants. The study started on 2022-05-17. Estimated completion is 2027-09.
What conditions does trial NCT05155254 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Unresectable Melanoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05155254?
The interventions under investigation include: Pembrolizumab (DRUG), IO102-IO103 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05155254?
This trial is sponsored by IO Biotech, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05155254 being conducted?
This trial has 20 study locations across Florida, New York, Virginia, New South Wales, Queensland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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