IO102-IO103 in Combination With Pembrolizumab Versus Pembrolizumab Alone in Advanced Melanoma (IOB-013 / KN-D18)
Metastatic Melanoma, Unresectable Melanoma
About this trial
This is an interventional treatment trial for Metastatic Melanoma focused on measuring Metastatic melanoma, Unresectable melanoma, Immunotherapy, Progression free survival, IO102-IO103, Pembrolizumab
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 proto-oncogene B-Raf (BRAFV600) mutation-positive melanoma are eligible if treatment naive and without rapidly progressive disease as per investigator assessment.
- 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 (not a cutaneous 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.
Sites / Locations
- Providence Saint John's Health Center
- Mid Florida Hematology and Oncology CenterRecruiting
- Orlando Health Cancer InstituteRecruiting
- University of Kentucky Markey Cancer Center
- Roswell Park Cancer InstituteRecruiting
- VCU Massey Cancer CenterRecruiting
- Border Medical Oncology Research UnitRecruiting
- Westmead HospitalRecruiting
- Southern Medical Day Care CentreRecruiting
- Cairns HospitalRecruiting
- Flinders Medical CentreRecruiting
- The Queen Elizabeth Hospital
- Sunshine Coast University HospitalRecruiting
- Peter MacCallum Cancer Centre PMCC - East MelbourneRecruiting
- Universitair Ziekenhuis Gent UZ GentRecruiting
- AZ Sint-Jan Brugge - Oostende AV - Campus Sint-JanRecruiting
- CHIRECRecruiting
- AZ NikolaasRecruiting
- FNHK Klinika onkologie a radioterapieRecruiting
- Fakultni Nemocnice OlomoucRecruiting
- FN OstravaRecruiting
- FNKV Department of DermatologyRecruiting
- Aalborg University HospitalRecruiting
- Aarhus University HospitalRecruiting
- Herlev og Gentofte HospitalRecruiting
- Odense University HospitalRecruiting
- Centre Hospitalier Universitaire de Besançon Jean MinjozRecruiting
- Centre Hospitalier Universitaire de Bordeaux Hospital Saint AndreRecruiting
- Hopital AmbroiseRecruiting
- Centre Georges Francois LeclercRecruiting
- Chu Grenoble - Hopital Albert MichallonRecruiting
- Centre Hospitalier Universitaire de LilleRecruiting
- Hôpital de La TimoneRecruiting
- CHU de Nice Hpital de lArchet 2Recruiting
- Centre Hospitalier Lyon SudRecruiting
- Centre Eugene MarquisRecruiting
- Institut de Cancérologie de L'OuestRecruiting
- Centre Hospitalier de Valence (CHV)Recruiting
- Gustave RoussyRecruiting
- Universitatsklinikum Augsburg Medizincampus SuedRecruiting
- Charite Universitaetsmedizin BerlinRecruiting
- St. Josef Hospital - Ruhr-Universitt BochumRecruiting
- University Hospital ErlangenRecruiting
- Universitaetsklinikum EssenRecruiting
- University Hospital Frankfurt Theodor-Stern-KaiRecruiting
- Elbe Klinikum BuxtehudeRecruiting
- Nationales Centrum fr Tumorerkrankungen NCTRecruiting
- SLK-Kliniken Heilbronn GmbHRecruiting
- Universitaetsklinikum Schleswig-HolsteinRecruiting
- Department of Dermatology University of MainzRecruiting
- Universitatsmedizin Mannheim DermatologieRecruiting
- Mühlenkreiskliniken AöR, University Hospital Ruhr University Bochum Campus MindenRecruiting
- LMU MuenchenRecruiting
- Hospital TubingenRecruiting
- Universittsklinikum WuerzburgRecruiting
- Orszagos Onkologiai IntezetRecruiting
- Bor, -Nemikortani es Onkodermatologiai KlinikaRecruiting
- Hetenyi G Korhaz, Onkologiai KozpontRecruiting
- Mater Public Hospital
- Emek Medical CenterRecruiting
- Ben-Gurion University of the Negev - Soroka University Medical Center - Soroka Clinical Research CenterRecruiting
- Hadassah University HospitalRecruiting
- Rabin Medical CenterRecruiting
- Tel Aviv Sourasky Medical CenterRecruiting
- The Chaim Sheba Medical Center - The Ella Lemelbaum Institute for Immuno-OncologyRecruiting
- Clinica Oncologica, AOU Riuniti anconaRecruiting
- Centro di Riferimento OncologicoRecruiting
- Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico BariRecruiting
- IRCCS Ospedale San RaffaeleRecruiting
- IRCCS Ospedale Policlinico San MartinoRecruiting
- Istituto Romagnolo per lo Studio dei Tumori " DINO AMADORI"Recruiting
- Fondazione IRCCS Istituto Nazionale dei TumoriRecruiting
- Istituto Nazionale Tumori IRCCS Fondazione PascaleRecruiting
- Veneto Oncology InstituteRecruiting
- Ospedale S. Maria della MisericordiaRecruiting
- Idi-IrccsRecruiting
- Azienda Ospedaliera Universitaria Senese Policlinico Le ScotteRecruiting
- The Netherlands Cancer InstituteRecruiting
- AMC Amsterdam, locatie VUMCRecruiting
- LUMCRecruiting
- UMC MaastrichtRecruiting
- Erasmus MCRecruiting
- University Medical Center UtrechtRecruiting
- Maria Sklodowska-Curie National Research Institute of OncologyRecruiting
- Szpital Kliniczny im. Heliodora Święcickiego UM w PoznaniuRecruiting
- Cape Town Oncology Trials (Pty) Ltd.Recruiting
- Mary Potter Oncology Centre GroenkloofRecruiting
- Hospital Universitario Virgen MacarenaRecruiting
- CH Universitario de A Coruña (CHUAC)Recruiting
- Hospital Clinic i ProvincialRecruiting
- Instituto Oncologico Dr. Rosell IOR - Hospital Universitari Quiron DexeusRecruiting
- Hospital Universitari Germans Trias i Pujol HUGTP, ICO-BadalonaRecruiting
- Hospital Vall d'hebronRecruiting
- Hospital General Universitario Gregorio MarañonRecruiting
- Clinica Universidad de NavarraRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Universitario HM SanchinarroRecruiting
- Hospital Regional Universitario de MalagaRecruiting
- Hospital Universitario Central de Asturias (HUCA)Recruiting
- Clinica Universidad de NavarraRecruiting
- Hospital General Universitario de ValenciaRecruiting
- Hospital Universitari i Politecnic La FeRecruiting
- Miguel Servet University HospitalRecruiting
- Adana City Education and Research Hospital
- Gulhane School of MedicineRecruiting
- Memorial Ankara HospitalRecruiting
- Akdeniz University Medical FacultyRecruiting
- Ege university Faculty of Medicine, T. Aktas Oncology Hospital, BornovaRecruiting
- Istanbul University-Cerrahpasa, Cerrahpasa Medical FacultyRecruiting
- Goztepe Prof. Dr. Suleyman Yalcin Sehir HastanesiRecruiting
- Guy's HospitalRecruiting
- Christie Hospital NHS Trust
- Christie Hospital NHS TrustRecruiting
- Oxford University Hospitals NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
IO102-IO103 + pembrolizumab
pembrolizumab
IO102-IO103 subcutaneous injections (85µg) every 3 weeks for a maximum 35 cycles (up to 2 years treatment). Additional dose given during the induction period on Day 8 of cycles 1 and 2. Each patient can be treated for a maximum of 37 administrations in total (up to 2 years treatment). Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles.
Pembrolizumab 200 mg intravenously every 3 weeks for a maximum of 35 cycles (up to 2 years treatment).