Melanoma Clinical Trial
IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
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: Unresectable stage IIID or stage 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 corresponding to around 2 years of 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, corresponding to around 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.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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There are 106 Locations for this study
Orange City Florida, 32763, United States
Orlando Florida, 32806, United States
Buffalo New York, 14221, United States
Richmond Virginia, 23219, United States
Albury New South Wales, 2640, Australia
Westmead New South Wales, 2145, Australia
Wollongong New South Wales, 2500, Australia
Cairns Queensland, 4870, Australia
Bedford Park South Australia, 5042, Australia
Woodville South South Australia, 5011, Australia
Birtinya , 4575, Australia
Melbourne , 3052, Australia
Gent Oost-Vlaanderen, 9000, Belgium
Sint-Niklaas , 9100, Belgium
Hradec Králové , 500 0, Czechia
Olomouc , 779 0, Czechia
Ostrava , 708 5, Czechia
Praha , 10034, Czechia
Aalborg , 9000, Denmark
Aarhus , 8200, Denmark
Herlev , 2730, Denmark
Odense , 5000, Denmark
Besancon , 25000, France
Bordeaux , 33075, France
Boulogne Billancourt , 92100, France
Dijon , 21079, France
La Tronche , 38700, France
Lille , 59000, France
Marseille cedex 05 , 13385, France
Nice , 6200, France
Pierre Benite , 69495, France
Rennes Cedex , 35042, France
Saint Herblain , 44805, France
Valence , 26 95, France
Villejuif Cedex , 94805, France
Augsburg , 86179, Germany
Berlin , 13353, Germany
Bochum , 44791, Germany
Erlangen , 90054, Germany
Essen , 45147, Germany
Frankfurt , 60590, Germany
Halle (Saale) , 6120, Germany
Hamburg , 22045, Germany
Heidelberg , 69120, Germany
Heilbronn , 74078, Germany
Kiel , 24105, Germany
Mainz , 55131, Germany
Mannheim , 68167, Germany
Minden , 32429, Germany
Muenchen , 80337, Germany
Münster , 48149, Germany
Tubingen , 72076, Germany
Wuerzburg , 97080, Germany
Budapest , 1122, Hungary
Pecs , 7632, Hungary
Szolnok , 5000, Hungary
Afula , , Israel
Beer Sheva , 84101, Israel
Jerusalem , 91120, Israel
Petah Tikva , 49414, Israel
Tel Aviv-Yafo , , Israel
Tel Hashomer , 52621, Israel
Ancona , 60126, Italy
Aviano , 33081, Italy
Bari , 70124, Italy
Candiolo , 10060, Italy
Genova , 16132, Italy
Meldola , 47014, Italy
Milano , 20133, Italy
Napoli , 80131, Italy
Padova , 35128, Italy
Perugia , 6156, Italy
Roma , 144, Italy
Rome , 00167, Italy
Siena , 53100, Italy
Amsterdam , 1066, Netherlands
Amsterdam , 1081, Netherlands
Leiden , 2300 , Netherlands
Maastricht , 6229H, Netherlands
Rotterdam , 1054 , Netherlands
Utrecht , 3584, Netherlands
Warsaw Masovian, 02-78, Poland
Poznan , 60-78, Poland
Cape Town , 7570, South Africa
Pretoria , 0181, South Africa
Seville Andalusia, 41009, Spain
A Coruña , 15006, Spain
Barcelona , 08036, Spain
Barcelona , 8028, Spain
Barcelona , 8916, Spain
Barcelona , , Spain
Madrid , 28007, Spain
Madrid , 28027, Spain
Madrid , 28034, Spain
Madrid , 28050, Spain
Malaga , 29010, Spain
Oviedo , 33011, Spain
Pamplona , 31008, Spain
Valencia , 46014, Spain
Valencia , 46026, Spain
Zaragoza , 50009, Spain
Adana , 1060, Turkey
Ankara , 6010, Turkey
Ankara , 6520, Turkey
Antalya , 7059, Turkey
Bornova , 35100, Turkey
Istanbul , 34098, Turkey
Istanbul , 34722, Turkey
London , SE1 9, United Kingdom
Manchester , M20 4, United Kingdom
Manchester , M20 4, United Kingdom
Oxford , OX3 7, United Kingdom
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