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

Running, not enrolling · Phase 3

Conditions studied: Metastatic Melanoma, Unresectable Melanoma

In brief

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.

Key facts

Study ID: NCT05155254
Run by: IO Biotech
People needed: 407
Starts: 2022-05-17
Expected to finish: 2027-09-01
Last updated by the study team: 2025-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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
Mid Florida Hematology and Oncology Center — Orange City, Florida, United States

Full record on ClinicalTrials.gov

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