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NCT05155254 · ClinicalTrials.gov registry record · Phase 3
IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
A Phase 3 study of Metastatic Melanoma and Unresectable Melanoma, sponsored by IO Biotech.
- Active
- Registry status
- Phase 3
- Development phase
- 407
- Enrollment target
- 20
- Study locations
NCT05155254: Active Phase 3 study of Metastatic Melanoma and Unresectable Melanoma, sponsored by IO Biotech.
NCT05155254 is a Phase 3 study of Metastatic Melanoma and Unresectable Melanoma that is active but no longer recruiting, run by IO Biotech. The registered enrollment target is 407 participants, above the 79-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (415% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05155254, a Phase 3 study of Metastatic Melanoma and Unresectable Melanoma, is active but no longer recruiting, sponsored by IO Biotech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 407 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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.
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 |
What the registry record for NCT05155254 still lists
NCT05155254 is an interventional study that assigns participants to a tested intervention. The registered 407 participants enrollment target is mid-sized for trials with a published cap, above the 79-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (415% higher).
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.
NCT05155254 names 20 study sites across 8 states, led by Other, New South Wales, Florida.
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.
What interventions are being tested in trial NCT05155254?
The interventions under investigation include: Pembrolizumab (DRUG), IO102-IO103 (DRUG).
Who is sponsoring clinical trial NCT05155254?
This trial is sponsored by IO Biotech, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05155254's enrollment target sits among peer trials
407 4th of 91 higher than 88 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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