Clinical trial • Phase III • Oncology|Ophthalmology
TEBENTAFUSP for Uveal melanoma
Phase III trial of TEBENTAFUSP for Uveal melanoma.
Overview
- Trial Therapeutic Area
- Oncology|Ophthalmology
- Trial Disease
- Uveal melanoma
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-05-2024
- First CTIS Authorization Date
- 18-09-2024
Trial design
Randomised, open-label, adjuvant tebentafusp (kimmtrak 100 micrograms/0.5 ml concentrate for solution for infusion; active substance tebentafusp) versus observation (no active treatment). dosing schedule not specified in ctis record.-controlled Phase III trial in France, Germany, Ireland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Adjuvant tebentafusp (KIMMTRAK 100 micrograms/0.5 mL concentrate for solution for infusion; active substance tebentafusp) versus observation (no active treatment). Dosing schedule not specified in CTIS record.
- Target Sample Size
- 110
Eligibility
Recruits 110 Vulnerable population flag is set (isVulnerablePopulationSelected: true). Consent requirements: written pre-screening informed consent and written informed consent according to ICH/GCP and local regulations are required. Only adults (18 years or older) are eligible, so consent is provided by the participant; no assent/parental consent procedures for minors are described. Participant information and consent documents are provided (languages and versions available in the repository)..
- Pregnancy Exclusion
- Screening: Evidence of post-menopausal status or negative urinary or serum pregnancy test for women of childbearing potential (WOCBP) within 3 days prior to randomization.
- Vulnerable Population
- Vulnerable population flag is set (isVulnerablePopulationSelected: true). Consent requirements: written pre-screening informed consent and written informed consent according to ICH/GCP and local regulations are required. Only adults (18 years or older) are eligible, so consent is provided by the participant; no assent/parental consent procedures for minors are described. Participant information and consent documents are provided (languages and versions available in the repository).
Inclusion criteria
- {"criterion_text":"- Pre-screening: Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy\n- Screening: Time-interval between the end of primary treatment and the randomization less than or equal to 12 weeks\n- Screening: Evidence of post-menopausal status or negative urinary or serum pregnancy test for women of childbearing potential (WOCBP) within 3 days prior to randomization.\n- Screening: For patients of childbearing / reproductive potential, agreement to use adequate birth control measures during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n- Screening: For female subjects who are breast feeding, agreement to discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment.\n- Screening: Written informed consent according to ICH/GCP and local regulations\n- Pre-screening: Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks)\n- Pre-screening: High-risk according to either 1) clinical criteria: TNM (AJCC8) stage III or 2) genetic criteria: monosomy 3 or GEP class 2. Prior to enrolment of the first patient, each site will declare which of the two genetic criteria it uses. Patients with stage I and stage II are only eligible if they meet the genetic criterion declared by the site\n- Pre-screening: ECOG performance status of 0 or 1\n- Pre-screening: 18 years or older\n- Pre-screening: Written pre-screening informed consent according to ICH/GCP and local regulations\n- Screening: HLA-A*02:01 positivity by local assessment\n- Screening: No evidence of UM recurrence, as evidenced by the required baseline imaging performed within 4 weeks prior to randomization\n- Screening: Adequate organ function:• Serum creatinine ≤ 1.5 × ULN and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) ≥ 40 mL/minute • Total bilirubin ≤ 1.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin ≥1.5 × ULN • Alanine aminotransferase ≤ 3 × ULN • Aspartate aminotransferase ≤ 3 × ULN • Absolute neutrophil count ≥ 1.0 × 10^9/L • Absolute lymphocyte count ≥ 0.5 × 10^9/L • Platelet count ≥ 150 × 10^9/L • Haemoglobin ≥ 10 g/dL"}
Exclusion criteria
- {"criterion_text":"- Clinically significant cardiac disease or impaired cardiac function, including any of the following: • Clinically significant and/or uncontrolled heart disease such as congestive heart failure (New York Heart Association grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia currently requiring medical treatment • QTcF > 470 msec on screening electrocardiogram (ECG) or congenital long QT syndrome based on at least 3 ECGs obtained over a brief time interval (i.e., within 30 minutes) • Acute myocardial infarction or unstable angina pectoris < 6 months prior to screening\n- Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to randomization\n- Any evidence of severe or uncontrolled systemic disease or active infection including hepatitis B, hepatitis C and known active human immunodeficiency virus (HIV) defined as >200 copies of HIV per ml of blood, active bleeding diatheses or renal transplant. • Participant with history of HBV infection will be eligible if on stable anti-viral therapy for > 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable during Screening. • Participant with history of HBC infection will be eligible the participant has received curative treatment and viral load was confirmed as undetectable during Screening.\n- History of another primary malignancy except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and with the following exception. Patients with a history of another primary cancer treated with curative intent more than 3 years before study entry, who are not receiving any anti-cancer therapy, have a risk of disease recurrence lower than 10% as evaluated by the local Investigator, and who have no toxicity from previous treatment are eligible\n- Participants with active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn’s disease), within 2 years of screening. NOTE: The following exceptions are permitted: • Vitiligo • Alopecia • Managed hypothyroidism (on stable replacement doses) • Asymptomatic adrenal insufficiency (on stable replacement doses) • Psoriasis • Resolved childhood asthma/atopy • Well-controlled asthma • Type I diabetes mellitus\n- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial\n- Known contraindication to imaging tracer or any product of contrast media and MRI and/or CT contraindications."}
Endpoints
Primary endpoints
- {"endpoint_text":"- RFS, defined as time between randomization and local recurrence, distant recurrence, or death, whichever occurs first.","definition_or_measurement_approach":"Time between randomization and local recurrence, distant recurrence, or death, whichever occurs first."}
Secondary endpoints
- {"endpoint_text":"- OS, defined as time between randomization and death","definition_or_measurement_approach":"Time between randomization and death."}
- {"endpoint_text":"- Safety of tebentafusp.","definition_or_measurement_approach":""}
Other endpoints
- {"endpoint_text":"- Biobanking, quality of life, Biomarker driven trial","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 110
- Recruitment Window Months
- 97
- Consent Approach
- Written informed consent is required according to ICH/GCP and local regulations; a written pre-screening informed consent is also specified. Consent is provided by adult participants (≥18 years). Subject information and informed consent forms (pre‑screening and enrolment) are available in multiple languages (English, French, Spanish, Italian, Dutch, Polish, German, Swedish and local language versions where provided).
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 200
France
- Earliest CTIS Part Ii Submission Date
- 27-08-2024
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 475
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncology
- Principal Investigator Name
- Agnes Ducoulombier
- Principal Investigator Email
- Agnes.DUCOULOMBIER@nice.unicancer.fr
- Contact Person Name
- Agnes Ducoulombier
- Contact Person Email
- Agnes.DUCOULOMBIER@nice.unicancer.fr
- Site Name
- Institut Curie
- Department Name
- Oncology
- Principal Investigator Name
- Manuel Rodrigues
- Principal Investigator Email
- manuel.rodrigues@curie.fr
- Contact Person Name
- Manuel Rodrigues
- Contact Person Email
- manuel.rodrigues@curie.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 09-09-2024
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 610
- Number Of Sites
- 4
- Number Of Participants
- 48
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik fuer Haematologie, Onkologie und Tumorimmunologie
- Principal Investigator Name
- Caroline Anna Peuker
- Principal Investigator Email
- Caroline-Anna.Peuker@charite.de
- Contact Person Name
- Caroline Anna Peuker
- Contact Person Email
- Caroline-Anna.Peuker@charite.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Dermatology
- Principal Investigator Name
- Christoffer Gebhardt
- Principal Investigator Email
- ch.gebhardt@uke.de
- Contact Person Name
- Christoffer Gebhardt
- Contact Person Email
- ch.gebhardt@uke.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Hautklinik
- Principal Investigator Name
- Jessica Hassel
- Principal Investigator Email
- jessica.hassel@med.uni-heidelberg.de
- Contact Person Name
- Jessica Hassel
- Contact Person Email
- jessica.hassel@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Medical Oncology
- Principal Investigator Name
- Halime Kalkavan
- Principal Investigator Email
- Halime.kalkavan@uk-essen.de
- Contact Person Name
- Halime Kalkavan
- Contact Person Email
- Halime.kalkavan@uk-essen.de
Ireland
- Earliest CTIS Part Ii Submission Date
- 25-08-2025
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 259
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- St Vincent's University Hospital
- Department Name
- Oncology
- Principal Investigator Name
- Sarah Lochrin
- Principal Investigator Email
- sarahlochrin@svhg.ie
- Contact Person Name
- Sarah Lochrin
- Contact Person Email
- sarahlochrin@svhg.ie
Netherlands
- Earliest CTIS Part Ii Submission Date
- 11-09-2024
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 608
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Oncology and Radiology & Nuclear Medicine
- Principal Investigator Name
- Astrid van der Veldt
- Principal Investigator Email
- a.vanderveldt@erasmusmc.nl
- Contact Person Name
- Astrid van der Veldt
- Contact Person Email
- a.vanderveldt@erasmusmc.nl
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Medical
- Principal Investigator Name
- Ellen Kapiteijn
- Principal Investigator Email
- h.w.kapiteijn@lumc.nl
- Contact Person Name
- Ellen Kapiteijn
- Contact Person Email
- h.w.kapiteijn@lumc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 23-08-2024
- Latest Decision Or Authorization Date
- 15-05-2026
- Processing Time Days
- 630
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Oncology
- Principal Investigator Name
- Piotr Rutkowski
- Principal Investigator Email
- piotr.rutkowski@nio.gov.pl
- Contact Person Name
- Piotr Rutkowski
- Contact Person Email
- piotr.rutkowski@nio.gov.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 698
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Oncology
- Principal Investigator Name
- Josep Piulats Rodriguez
- Principal Investigator Email
- jmpiulats@iconcologia.net
- Contact Person Name
- Josep Piulats Rodriguez
- Contact Person Email
- jmpiulats@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Oncology
- Principal Investigator Name
- Guillermo Antonio de Velasco Oria de Rueda
- Principal Investigator Email
- gdvelasco.gdv@gmail.com
- Contact Person Name
- Guillermo Antonio de Velasco Oria de Rueda
- Contact Person Email
- gdvelasco.gdv@gmail.com
- Site Name
- Hospital Clinico Universitario De Valladolid
- Department Name
- Oncology
- Principal Investigator Name
- Rafael Lopez Castro
- Principal Investigator Email
- rafalopezcastro@gmail.com
- Contact Person Name
- Rafael Lopez Castro
- Contact Person Email
- rafalopezcastro@gmail.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 08-08-2025
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 277
- Number Of Sites
- 1
- Number Of Participants
- 14
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Medical Oncology
- Principal Investigator Name
- Lars Ny
- Principal Investigator Email
- Lars.ny@oncology.gu.se
- Contact Person Name
- Lars Ny
- Contact Person Email
- Lars.ny@oncology.gu.se
Italy
- Earliest CTIS Part Ii Submission Date
- 27-08-2024
- Latest Decision Or Authorization Date
- 15-05-2026
- Processing Time Days
- 626
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- Melanoma, Cancer Immunotherapy and Development Therapeutics
- Principal Investigator Name
- Paolo Ascierto
- Principal Investigator Email
- p.ascierto@istitutotumori.na.it
- Contact Person Name
- Paolo Ascierto
- Contact Person Email
- p.ascierto@istitutotumori.na.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- Medical Oncology
- Principal Investigator Name
- Michele Del Vecchio
- Principal Investigator Email
- michele.delvecchio@istitutotumori.mi.it
- Contact Person Name
- Michele Del Vecchio
- Contact Person Email
- michele.delvecchio@istitutotumori.mi.it
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- Oncology
- Principal Investigator Name
- Ernesto Rossi
- Principal Investigator Email
- ernesto.rossi@policlinicogemelli.it
- Contact Person Name
- Ernesto Rossi
- Contact Person Email
- ernesto.rossi@policlinicogemelli.it
Belgium
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 621
- Number Of Sites
- 1
- Number Of Participants
- 21
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Oncology
- Principal Investigator Name
- Jean-Francois Baurain
- Principal Investigator Email
- jean-francois.baurain@uclouvain.be
- Contact Person Name
- Jean-Francois Baurain
- Contact Person Email
- jean-francois.baurain@uclouvain.be
Sponsor
Primary sponsor
- Full Name
- European Organisation For Research And Treatment Of Cancer
- Organisation Type
- Patient organisation/association
- Country Of Registered Address
- Belgium
Third parties
- {"country":"France","full_name":"Institut Curie","duties_or_roles":"External Imaging Reviewer","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Azienda Ospedaliera Universitaria Integrata Verona","duties_or_roles":"External Imaging Reviewer","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"France","full_name":"Cryoport France","duties_or_roles":"Sample Storage","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Stichting EuroQol Research Foundation","duties_or_roles":"Provider Quality of Life questionnaires","organisation_type":"Patient organisation/association"}
- {"country":"United States","full_name":"Radionix LLC","duties_or_roles":"External Imaging Reviewer","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- KIMMTRAK 100 micrograms/0.5 mL concentrate for solution for infusion
- Active Substance
- TEBENTAFUSP
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INFUSION
- Route
- INFUSION
- Authorisation Status
- Marketing authorisation EU/1/22/1630/001
- Orphan Designation
- Yes
- Maximum Dose
- 68 µg (maxDailyDoseAmount)
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