IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18) (NCT05155254)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Mid Florida Hematology and Oncology Center — Orange City, Florida
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (112 Sites)
Showing the first 25 of 112 sites.
- Mid Florida Hematology and Oncology Center — Orange City, Florida
- Orlando Health Cancer Institute — Orlando, Florida
- Roswell Park Cancer Institute — Buffalo, New York
- VCU Massey Cancer Center — Richmond, Virginia
- Border Medical Oncology Research Unit — Albury, New South Wales
- Westmead Hospital — Westmead, New South Wales
- Southern Medical Day Care Centre — Wollongong, New South Wales
- Cairns Hospital — Cairns, Queensland
- Flinders Medical Centre — Bedford Park, South Australia
- The Queen Elizabeth Hospital — Woodville South, South Australia
- Sunshine Coast University Hospital — Birtinya,
- Peter MacCallum Cancer Centre PMCC - East Melbourne — Melbourne,
- Universitair Ziekenhuis Gent UZ Gent — Ghent, Oost-Vlaanderen
- 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,
- Herlev og Gentofte Hospital — Herlev,
- Odense University Hospital — Odense,
- Centre Hospitalier Universitaire de Besançon Jean Minjoz — Besançon,
- Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre — Bordeaux,
- Hopital Ambroise — Boulogne-Billancourt,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Melanoma
- Abbreviated MAPK Targeted Therapy Plus Pembrolizumab in Melanoma — Boston, Massachusetts
- Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies — Jacksonville, Florida
- Genetically Modified T-Cells Followed by Aldesleukin in Treating Patients With Stage III-IV Melanoma — Houston, Texas
- Adjuvant, Combined Interleukin 2 (Proleukin) and DTIC (Dacarbazine) in High-risk Melanoma Patients — Louisville, Kentucky
- Comparison of High-dose IL-2 and High-dose IL-2 With Radiation Therapy in Patients With Metastatic Melanoma. — Portland, Oregon
Explore by condition: All Metastatic Melanoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.