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.

View Eligibility Criteria

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.

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT05155254

Recruitment Status:

Recruiting

Sponsor:

IO Biotech

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There are 74 Locations for this study

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Saint John's Cancer Institute
Santa Monica California, 90404, United States More Info
Kim Margolin, M.D.
Contact
[email protected]
Kim Margolin, M.D.
Principal Investigator
Mid Florida Hematology and Oncology Center
Orange City Florida, 32763, United States More Info
Santosh Nair
Contact
[email protected]
Santosh Nair, MD
Principal Investigator
Orlando Health Cancer Institute
Orlando Florida, 32806, United States More Info
Sajeve Thomas, MD
Contact
[email protected]
Sajeve Thomas, MD
Principal Investigator
University of Kentucky Markey Cancer Center
Lexington Kentucky, 40536, United States More Info
Yvonne Taul
Contact
[email protected]
Peng Wang, MD, PhD
Principal Investigator
Roswell Park Cancer Institute
Buffalo New York, 14221, United States More Info
Igor Puzanov, M.D.
Contact
[email protected]
Igor Puzanov, M.D.
Principal Investigator
VCU Massey Cancer Center
Richmond Virginia, 23219, United States More Info
Andrew Poklepovic
Contact
[email protected]
Andrew Poklepovic
Principal Investigator
Border Medical Oncology Research Unit
Albury New South Wales, 2640, Australia More Info
Craig Underhill, M.D.
Contact
[email protected]
Craig Underhill, M.D.
Principal Investigator
Westmead Hospital
Westmead New South Wales, 2145, Australia More Info
Matteo Carlino, M.D.
Contact
[email protected]
Matteo Carlino, M.D.
Principal Investigator
Southern Medical Day Care Centre
Wollongong New South Wales, 2500, Australia More Info
Daniel Brungs, M.D./Prof.
Contact
[email protected]
Daniel Brungs, M.D. A/Prof.
Principal Investigator
Cairns Hospital
Cairns Queensland, 4870, Australia More Info
Megan Lyle, M.D.
Contact
[email protected]
Megan Lyle, M.D.
Principal Investigator
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia More Info
Amitesh Roy
Contact
[email protected]
Amitesh Roy
Principal Investigator
Sunshine Coast University Hospital
Birtinya , 4575, Australia More Info
Mary Azer, M.D.
Contact
[email protected]
Mary Azer, M.D.
Principal Investigator
Peter MacCallum Cancer Centre PMCC - East Melbourne
Melbourne , 3052, Australia More Info
Shahneen Sandhu, M.D.
Contact
[email protected]
Shahneen Sandhu, M.D.
Principal Investigator
Universitair Ziekenhuis Gent UZ Gent
Gent Oost-Vlaanderen, 9000, Belgium More Info
Celine Jacobs, M.D.
Contact
[email protected]
Celine Jacobs, M.D.
Principal Investigator
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan
Brugge , 8000, Belgium More Info
Alain Bols, MD
Contact
[email protected]
Alain Bols, MD
Principal Investigator
CHIREC
Brussels , 1160, Belgium More Info
Corinne Gregoire
Contact
[email protected]
Corinne Gregoire
Principal Investigator
AZ Nikolaas
Sint-Niklaas , 9100, Belgium More Info
Vibeke Kruse, MD
Contact
[email protected]
Vibeke Kruse, MD
Principal Investigator
FNHK Klinika onkologie a radioterapie
Hradec Králové , 500 0, Czechia More Info
Jindrich Kopecky, MD
Contact
[email protected]
Jindrich Kopecky, MD
Principal Investigator
Fakultni Nemocnice Olomouc
Olomouc , 779 0, Czechia More Info
Bohuslav Melichar, MD
Contact
[email protected]
Bohuslav Melichar, MD
Principal Investigator
FN Ostrava
Ostrava , 708 5, Czechia More Info
Yvetta Vantuchova, MD
Contact
[email protected]
Yvetta Vantuchova, MD
Principal Investigator
Aalborg University Hospital
Aalborg , 9000, Denmark More Info
Charlotte Haslund, MD
Contact
[email protected]
Charlotte Haslund, MD
Principal Investigator
Aarhus University Hospital
Aarhus , 8200, Denmark More Info
Henrik Schmidt, MD
Contact
[email protected]
Henrik Schmidt, MD
Principal Investigator
Herlev og Gentofte Hospital
Herlev , 2730, Denmark More Info
Inge M. Svane, M.D.
Contact
[email protected]
Inge M. Svane, M.D.
Principal Investigator
Odense University Hospital
Odense , 5000, Denmark More Info
Lars Bastholt
Contact
[email protected]
Lars Bastholt
Principal Investigator
Centre Hospitalier Universitaire de Besançon Jean Minjoz
Besancon , 25000, France More Info
Charlee Nardin, Dr.
Contact
Charlee Nardin, Dr.
Principal Investigator
Centre Hospitalier Universitaire de Bordeaux Hospital Saint Andre
Bordeaux , 33075, France More Info
Caroline Dutriaux, M.D.
Contact
[email protected]
Caroline Dutriaux, M.D.
Principal Investigator
Hopital Ambroise
Boulogne Billancourt , 92100, France More Info
Philippe Saiag, Prof.
Contact
Philippe Saiag, Prof
Principal Investigator
Chu Grenoble - Hopital Albert Michallon
La Tronche , 38700, France More Info
Marie Enquebecq, MD
Contact
[email protected]
Marie Enquebecq, MD
Principal Investigator
Centre Hospitalier Universitaire de Lille
Lille , 59000, France More Info
Laurent Mortier, M.D.
Contact
[email protected]
Laurent Mortier, M.D.
Principal Investigator
Hôpital de La Timone
Marseille cedex 05 , 13385, France More Info
Caroline Gaudy, Prof
Contact
[email protected]
Caroline Gaudy, Prof
Principal Investigator
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France More Info
Stephane Dalle, M.D.
Contact
478861679
[email protected]
Stephane Dalle, M.D.
Principal Investigator
Centre Eugene Marquis
Rennes Cedex , 35042, France More Info
Thierry Lesimple, M.D.
Contact
[email protected]
Thierry Lesimple, M.D.
Principal Investigator
Institut de Cancérologie de L'Ouest
Saint Herblain , 44805, France More Info
Melanie Saint-Jean
Contact
[email protected]
Melanie Saint-Jean, MD
Principal Investigator
Centre Hospitalier de Valence (CHV)
Valence , 26 95, France More Info
Florent Grange, M.D.
Contact
[email protected]
Florent Grange, M.D.
Principal Investigator
Gustave Roussy
Villejuif Cedex , 94805, France More Info
Caroline Robert, M.D.
Contact
[email protected]
Caroline Robert, M.D.
Principal Investigator
Charite Universitaetsmedizin Berlin
Berlin , 13353, Germany More Info
Max Schlaak, M.D.
Contact
[email protected]
Max Schlaak, M.D.
Principal Investigator
St. Josef Hospital - Ruhr-Universitt Bochum
Bochum , 44791, Germany More Info
Thilo Gamblichler
Contact
[email protected]
Thilo Gamblicher
Principal Investigator
University Hospital Erlangen
Erlangen , 90054, Germany More Info
Carola Berking, MD
Contact
[email protected]
Carola Berking, MD
Principal Investigator
Universitaetsklinikum Essen
Essen , 45147, Germany More Info
Dirk Schadendorf, M.D.
Contact
2017232325
[email protected]
Dirk Schadendorf, M.D.
Principal Investigator
Elbe Klinikum Buxtehude
Hamburg , 22045, Germany More Info
Peter Mohr
Contact
[email protected]
Peter Mohr
Principal Investigator
Nationales Centrum fr Tumorerkrankungen NCT
Heidelberg , 69120, Germany More Info
Jessica Hassel, M.D.
Contact
6221568562
[email protected]
Jessica Hassel, M.D.
Principal Investigator
SLK-Kliniken Heilbronn GmbH
Heilbronn , 74078, Germany More Info
Uwe Martens, M.D.
Contact
[email protected]
Uwe Martens, M.D.
Principal Investigator
Universitaetsklinikum Schleswig-Holstein
Kiel , 24105, Germany More Info
Patrick Terheyden, MD
Contact
[email protected]
Patrick Terheyden, MD
Principal Investigator
Department of Dermatology University of Mainz
Mainz , 55131, Germany More Info
Stephan Grabbe, MD
Contact
[email protected]ainz.de
Stephan Grabbe, MD
Principal Investigator
Universitatsmedizin Mannheim Dermatologie
Mannheim , 68167, Germany More Info
Jochen Utikal, MD
Contact
[email protected]
Jochen Utikal, MD
Principal Investigator
Mühlenkreiskliniken AöR, University Hospital Ruhr University Bochum Campus Minden
Minden , 32429, Germany More Info
Ralf Gutzmer, Prof.
Contact
Ralf Gutzmer, Prof.
Principal Investigator
Hospital Tubingen
Tubingen , 72076, Germany More Info
Teresa Amaral, MD
Contact
[email protected]
Teresa Amaral, MD
Principal Investigator
Universittsklinikum Wuerzburg
Wuerzburg , 97080, Germany More Info
Bastian Schilling, MD
Contact
[email protected]
Bastian Schilling, MD
Principal Investigator
Orszagos Onkologiai Intezet
Budapest , 1122, Hungary More Info
Gabriella Liszkay, M.D.
Contact
[email protected]
Gabriella Liszkay, M.D.
Principal Investigator
Bor, -Nemikortani es Onkodermatologiai Klinika
Pecs , 7632, Hungary More Info
Rolland Gyulai, M.D.
Contact
[email protected]
Rolland Gyulai, M.D.
Principal Investigator
Hetenyi G Korhaz, Onkologiai Kozpont
Szolnok , 5000, Hungary More Info
Tibor Csoszi, M.D.
Contact
[email protected]
Tibor Csoszi, M.D.
Principal Investigator
Emek Medical Center
Afula , , Israel More Info
Gil Bar-Sela, MD
Contact
[email protected]
Gil Bar-Sela, MD
Principal Investigator
Hadassah University Hospital
Jerusalem , 91120, Israel More Info
Michal Lotem, MD
Contact
[email protected]
Michal Lotem, MD
Principal Investigator
Tel Aviv Sourasky Medical Center
Tel Aviv-Yafo , , Israel More Info
Mor Miodovnik, MD
Contact
[email protected]
Mor Miodovnik, MD
Principal Investigator
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli , 80131, Italy More Info
Paolo Ascierto, MD
Contact
[email protected]
Paolo Ascierto, MD
Principal Investigator
Idi-Irccs
Rome , 00167, Italy More Info
Paolo Marchetti, MD
Contact
[email protected]
Paolo Marchetti, MD
Principal Investigator
AOUS Le Scotte
Siena , 53100, Italy More Info
Michele Maio, MD
Contact
[email protected]
Michele Maio, MD
Principal Investigator
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena , 53100, Italy More Info
Michele Maio, Prof
Contact
[email protected]
MIchele Maio, Prof
Principal Investigator
The Netherlands Cancer Institute
Amsterdam , 1066, Netherlands More Info
Christian Blank, M.D.
Contact
[email protected]
Christian Blank, M.D.
Principal Investigator
AMC Amsterdam, locatie VUMC
Amsterdam , 1081, Netherlands More Info
Fons van den Eertwegh, MD
Contact
[email protected]
Fons van den Eertwegh, MD
Principal Investigator
LUMC
Leiden , 2300 , Netherlands More Info
Ellen Kapiteijn, MD
Contact
[email protected]
Ellen Kapiteijn, MD
Principal Investigator
UMC Maastricht
Maastricht , 6229H, Netherlands More Info
Maureen Aarts, MD
Contact
[email protected]
Maureen Aarts, MD
Principal Investigator
Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw Masovian, 02-78, Poland More Info
Piotr Rutkowski
Contact
[email protected]
Piotr Rutkowski
Principal Investigator
Cape Town Oncology Trials (Pty) Ltd.
Cape Town , 7570, South Africa More Info
Conrad Jacobs, M.D.
Contact
[email protected]
Conrad Jacobs, M.D.
Principal Investigator
Mary Potter Oncology Centre Groenkloof
Pretoria , 0181, South Africa More Info
Cohen Graham, MD
Contact
[email protected]
Cohen Graham, MD
Principal Investigator
Hospital Universitario Virgen Macarena
Seville Andalusia, 41009, Spain More Info
Luis de la Cruz Merino, M.D.
Contact
[email protected]
Luis de la Cruz Merino, M.D.
Principal Investigator
CH Universitario de A Coruña (CHUAC)
A Coruña , 15006, Spain More Info
Maria Q. Varela, M.D.
Contact
[email protected]
Maria Q. Varela, M.D.
Principal Investigator
Hospital Clinic i Provincial
Barcelona , 08036, Spain More Info
Ana Maria A Fernandez, M.D.
Contact
[email protected]
Ana Maria A Fernandez, M.D.
Principal Investigator
Instituto Oncologico Dr. Rosell IOR - Hospital Universitari Quiron Dexeus
Barcelona , 8028, Spain More Info
Maria Gonzalez-Cao, M.D.
Contact
[email protected]
Maria Gonzalez-Cao, M.D.
Principal Investigator
Hospital Vall d'hebron
Barcelona , , Spain More Info
Eva Munoz Cosuelo
Contact
[email protected]
Eva Munoz Cosuelo
Principal Investigator
Hospital General Universitario Gregorio Marañon
Madrid , 28007, Spain More Info
Ivan Marquez Rodas, MD
Contact
[email protected]
Ivan Marquez Rodas, MD
Principal Investigator
Clinica Universidad de Navarra
Madrid , 28027, Spain More Info
EDUARDO CASTAÑON, MD
Contact
[email protected]
EDUARDO CASTAÑON, MD
Principal Investigator
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain More Info
Ainara S. Rivas, M.D.
Contact
[email protected]
Ainara S Rivas, M.D.
Principal Investigator
Hospital Universitario HM Sanchinarro
Madrid , 28050, Spain More Info
Juan Francisco Rodriguez, M.D.
Contact
[email protected]
Juan Francisco Rodriguez, M.D.
Principal Investigator
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain More Info
Miguel Berciano, MD
Contact
[email protected]
Miguel Berciano, MD
Principal Investigator
Hospital Universitario Central de Asturias (HUCA)
Oviedo , 33011, Spain More Info
Isabel Palacio Vazquez, MD
Contact
[email protected]
Isabel Palacio Vazquez, MD
Principal Investigator
Hospital General Universitario de Valencia
Valencia , 46014, Spain More Info
Alfonso Berrocal Jaime, MD
Contact
[email protected]
Alfonso Berrocal Jaime, MD
Principal Investigator
Hospital Universitari i Politecnic La Fe
Valencia , 46026, Spain More Info
Roberto D. Beveridge, M.D.
Contact
[email protected]
Roberto D. Beveridge, M.D.
Principal Investigator
Miguel Servet University Hospital
Zaragoza , 50009, Spain More Info
Teresa Puertolas Hernandez, MD
Contact
[email protected]
Teresa Puertolas Hernandez, MD
Principal Investigator
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom More Info
Paul Lorigan, MD
Contact
[email protected]
Paul Lorigan, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 3

Estimated Enrollment:

300

Study ID:

NCT05155254

Recruitment Status:

Recruiting

Sponsor:


IO Biotech

How clear is this clinincal trial information?

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