Clinical trial • Phase III • Oncology
AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS for Cutaneous melanoma
Phase III trial of AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGE…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Cutaneous melanoma
- Trial Stage
- Phase III
- Drug Modality
- Cell therapy | Monoclonal antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 15-01-2025
- First CTIS Authorization Date
- 16-04-2025
Trial design
Randomised, open-label, investigator’s choice of treatment: options include nivolumab plus relatlimab (opdualag®), lifileucel, nivolumab, pembrolizumab, ipilimumab, or chemotherapy (examples provided: dacarbazine, temozolomide, paclitaxel, albumin-bound paclitaxel, paclitaxel plus carboplatin). (no dose/schedule specified in the part i/ii descriptive text.)-controlled Phase III trial across 17 sites in Germany, Netherlands, France.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Investigator’s choice of treatment: options include nivolumab plus relatlimab (Opdualag®), lifileucel, nivolumab, pembrolizumab, ipilimumab, or chemotherapy (examples provided: dacarbazine, temozolomide, paclitaxel, albumin-bound paclitaxel, paclitaxel plus carboplatin). (No dose/schedule specified in the Part I/II descriptive text.)
- Target Sample Size
- 276
Eligibility
Recruits 276 Vulnerable population selected. Subject information sheets and informed consent forms are provided for adults and for legal guardians (documents include titles such as 'L1_SIS and ICF_adults legal guardian' in English and German), indicating consent/guardian consent procedures are in place; information and ICFs are available in multiple languages (English, German, French, Dutch) as evidenced by available document versions..
- Pregnancy Exclusion
- The patient is pregnant or is breastfeeding.
- Vulnerable Population
- Vulnerable population selected. Subject information sheets and informed consent forms are provided for adults and for legal guardians (documents include titles such as 'L1_SIS and ICF_adults legal guardian' in English and German), indicating consent/guardian consent procedures are in place; information and ICFs are available in multiple languages (English, German, French, Dutch) as evidenced by available document versions.
Inclusion criteria
- {"criterion_text":"- Patients ≥ 18 years of age"}
- {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1"}
- {"criterion_text":"- Confirmed HLA status"}
- {"criterion_text":"- Adequate renal, hepatic and pulmonary function, acceptable coagulation status, adequate organ and marrow function"}
- {"criterion_text":"- Measurable disease according to RECIST 1.1"}
- {"criterion_text":"- Pathologically confirmed and documented cutaneous melanoma, CM patients with unresectable or metastatic (= advanced) disease who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor"}
- {"criterion_text":"- Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy unless deemed not clinically indicated at Investigator’s discretion due to concurrent medical condition, prior toxicity, or if declined by the patient"}
- {"criterion_text":"- The patient must have recovered from any side effects of prior therapy to grade 1 or lower prior to randomization, and prior to LD and subsequent treat-ment"}
Exclusion criteria
- {"criterion_text":"- Primary mucosal or uveal melanoma"}
- {"criterion_text":"- History of other malignancies within the last 3 years"}
- {"criterion_text":"- Patients with prior allogeneic stem-cell transplantation or solid-organ transplantation"}
- {"criterion_text":"- The patient is pregnant or is breastfeeding."}
- {"criterion_text":"- History of hypersensitivity to treatment in the IMA203 arm or rescue medications or presence of any contraindications and other limitations for planned treatment with investigator’s choice"}
- {"criterion_text":"- Any condition contraindicating leukapheresis"}
- {"criterion_text":"- The patient has concurrent severe and/or uncontrolled medical disease. Any other condition that would, in the investigator’s judgement, contraindicate the patient’s participation in the clinical trial because of safety concerns or com-pliance with clinical trial procedures"}
- {"criterion_text":"- Patients with active brain metastases or leptomeningeal metastases at VA/VB"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free survival (PFS), centrally assessed by a Blinded Independent Central Review (BICR) using RECIST 1.1","definition_or_measurement_approach":"Centrally assessed by a Blinded Independent Central Review (BICR) using RECIST 1.1"}
Recruitment
- Digital Remote Recruitment
- True - digital methods explicitly referenced include trial website materials and social media recruitment posts (country-specific versions exist).
- Planned Sample Size
- 276
- Recruitment Window Months
- 79
- Consent Approach
- Informed consent is obtained using subject information sheets and ICFs for adults; legal guardian ICFs are provided where applicable. Multiple language versions of ICF and information materials are available (English, German, French, Dutch). Specific documents include 'L1_SIS and ICF_adults ICF1/ICF2' and 'L1_SIS and ICF_adults legal guardian' (EN/DE/NL/FR) and other related privacy and pregnancy follow-up ICFs.
Methods
- Recruitment materials and arrangements documented (country-specific documents for Germany, France, Netherlands).
- Trial website (documents titled 'K2_Recruitment material_IMA203-301 trial website' available in multiple languages).
- Social media posts (documents titled 'K2_Recruitment material_social media posts_Redacted').
- Graphical overview materials (documents titled 'K2_Recruitment material_graphical overview' in EN/DE/NL/FR).
Geography
- Total Number Of Sites
- 17
- Total Number Of Participants
- 108
Germany
- Earliest CTIS Part Ii Submission Date
- 21-03-2025
- Latest Decision Or Authorization Date
- 04-03-2026
- Processing Time Days
- 348
- Number Of Sites
- 11
- Number Of Participants
- 84
Sites
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Jan Simon
- Principal Investigator Email
- jan.simon@medizin.uni-leipzig.de
- Contact Person Name
- Jan Simon
- Contact Person Email
- jan.simon@medizin.uni-leipzig.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Klinik und Poliklinik für Dermatologie und Venerologie
- Principal Investigator Name
- Christoffer Gebhardt
- Principal Investigator Email
- studien-htz@uke.de
- Contact Person Name
- Christoffer Gebhardt
- Contact Person Email
- studien-htz@uke.de
- Site Name
- University Hospital Cologne AöR
- Department Name
- Klinik und Poliklinik für Dermatologie und Venerologie
- Principal Investigator Name
- Cindy Franklin
- Principal Investigator Email
- Cindy.Franklin@uk-koeln.de
- Contact Person Name
- Cindy Franklin
- Contact Person Email
- Cindy.Franklin@uk-koeln.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Medizinische Klinik und Poliklinik III
- Principal Investigator Name
- Friederike Schmitz
- Principal Investigator Email
- Friederike.Schmitz@ukbonn.de
- Contact Person Name
- Friederike Schmitz
- Contact Person Email
- Friederike.Schmitz@ukbonn.de
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- III. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Eva Maria Wagner-Drouet
- Principal Investigator Email
- eva.wagner@unimedizin-mainz.de
- Contact Person Name
- Eva Maria Wagner-Drouet
- Contact Person Email
- eva.wagner@unimedizin-mainz.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- DermatoOnkologie der Hautklinik im Nationalen Centrum für Tumorerkrankungen (NCT)
- 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
- Technische Universitaet Dresden
- Department Name
- Early Clinical Trial Unit (NCT/UCC ECTU)
- Principal Investigator Name
- Martin Wermke
- Principal Investigator Email
- martin.wermke@uniklinikum-dresden.de
- Contact Person Name
- Martin Wermke
- Contact Person Email
- martin.wermke@uniklinikum-dresden.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Department for Dermatology
- Principal Investigator Name
- Dirk Schadendorf
- Principal Investigator Email
- Hautklinik.Studienzentrum@heh.uk-essen.de
- Contact Person Name
- Dirk Schadendorf
- Contact Person Email
- Hautklinik.Studienzentrum@heh.uk-essen.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- Department of Dermatology
- Principal Investigator Name
- Carola Berking
- Principal Investigator Email
- onkstudienzentrale.de@uk-erlangen.de
- Contact Person Name
- Carola Berking
- Contact Person Email
- onkstudienzentrale.de@uk-erlangen.de
- Site Name
- Goethe University Frankfurt
- Department Name
- Abteilung für Dermatologie, Venerologie und Allergologie
- Principal Investigator Name
- Bastian Schilling
- Principal Investigator Email
- bastian.schilling@ukffm.de
- Contact Person Name
- Bastian Schilling
- Contact Person Email
- bastian.schilling@ukffm.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Hämatologie und Onkologie, Comprehensive Cancer Center (CCC)
- Principal Investigator Name
- Antonia Busse
- Principal Investigator Email
- antonia.busse@charite.de
- Contact Person Name
- Antonia Busse
- Contact Person Email
- antonia.busse@charite.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 08-04-2026
- Latest Decision Or Authorization Date
- 13-04-2026
- Processing Time Days
- 5
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Medical Oncology
- 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
- Universitair Medisch Centrum Groningen
- Department Name
- Medical Oncology
- Principal Investigator Name
- M Jalving
- Principal Investigator Email
- researchcoordinator@onco.umcg.nl
- Contact Person Name
- M Jalving
- Contact Person Email
- researchcoordinator@onco.umcg.nl
- Site Name
- Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
- Department Name
- Centrum voor Celtherapie
- Principal Investigator Name
- John Haanen
- Principal Investigator Email
- j.haanen@nki.nl
- Contact Person Name
- John Haanen
- Contact Person Email
- j.haanen@nki.nl
France
- Earliest CTIS Part Ii Submission Date
- 16-02-2026
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 63
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Dermatology
- Principal Investigator Name
- Laurent Mortier
- Principal Investigator Email
- laurent.mortier@chru-lille.fr
- Contact Person Name
- Laurent Mortier
- Contact Person Email
- laurent.mortier@chru-lille.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Dermatology
- Principal Investigator Name
- Caroline Robert
- Principal Investigator Email
- caroline.robert@gustaveroussy.fr
- Contact Person Name
- Caroline Robert
- Contact Person Email
- caroline.robert@gustaveroussy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hôpital Saint Louis Dermatology
- Principal Investigator Name
- Celeste Lebbe
- Principal Investigator Email
- Celeste.lebbe@aphp.fr
- Contact Person Name
- Celeste Lebbe
- Contact Person Email
- Celeste.lebbe@aphp.fr
Sponsor
Primary sponsor
- Full Name
- Immatics US Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Metronomia Clinical Research GmbH
- Responsibilities
- Biostatistic data management
- Name
- CCR Creative Clinical Research GmbH Privates Institut fuer Kreative Klinische Forschung
- Name
- Winicker-Norimed GmbH Medizinische Forschung
Third parties
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"System Provider","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Germany","full_name":"Metronomia Clinical Research GmbH","duties_or_roles":"Biostatistic data management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"Discovery Life Sciences Biomarker Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Cogitars GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"CCR Creative Clinical Research GmbH Privates Institut fuer Kreative Klinische Forschung","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Imaging Endpoints II LLC","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"Cerba Research","duties_or_roles":"Storage of samples","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"ProtaGene CGT GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Genewiz Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"spm²-safety projects & more GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"ProtaGene CGT GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"MicroCoat Biotechnologie GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Angle Europe Limited","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Winicker-Norimed GmbH Medizinische Forschung","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- IMA203
- Active Substance
- AUTOLOGOUS T-CELLS TRANSDUCED WITH THE LENTIVIRAL LV-R11KEA ENCODING T-CELL RECEPTOR TARGETING PATIENT-SPECIFIC TUMOR-ASSOCIATED ANTIGENS
- Modality
- Cell therapy
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 10000000000 DF dosage form
- Investigational Product Name
- NIVOLUMAB
- Active Substance
- NIVOLUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous injection; Intravenous infusion
- Route
- Subcutaneous injection / Intravenous infusion
- Maximum Dose
- 1200 mg (maxDailyDoseAmount recorded for one formulation); 480 mg (for infusion formulation)
- Investigational Product Name
- PACLITAXEL
- Active Substance
- PACLITAXEL
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 225 mg/m2
- Investigational Product Name
- TEMOZOLOMIDE
- Active Substance
- TEMOZOLOMIDE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion; Oral
- Route
- Intravenous infusion / Oral
- Maximum Dose
- 200 mg/m2
- Investigational Product Name
- PACLITAXEL ALBUMIN-BOUND
- Active Substance
- PACLITAXEL ALBUMIN-BOUND
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 100 mg/m2
- Investigational Product Name
- Opdualag 240 mg/80 mg concentrate for solution for infusion
- Active Substance
- NIVOLUMAB, RELATLIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Authorisation Status
- EU/1/22/1679/001
- Maximum Dose
- 480 mg
- Investigational Product Name
- CARBOPLATIN
- Active Substance
- CARBOPLATIN
- Modality
- Small molecule
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 900 mg
- Investigational Product Name
- PEMBROLIZUMAB
- Active Substance
- PEMBROLIZUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 400 mg
- Investigational Product Name
- IPILIMUMAB
- Active Substance
- IPILIMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Intravenous infusion
- Route
- Intravenous infusion
- Maximum Dose
- 3 mg/kg
- Investigational Product Name
- DACARBAZINE
- Active Substance
- DACARBAZINE
- Modality
- Small molecule
- Routes Of Administration
- Intravenous injection/infusion
- Route
- Intravenous injection/infusion
- Maximum Dose
- 250 mg/m2
- Combination Treatment
- Yes
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