Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
310
Countries
9
Sites
20
Uveal Melanoma
To prospectively assess whether adjuvant treatment with tebentafusp improves recurrence-free survival (RFS) as compared to observation.
Key facts
- Sponsor
- European Organisation For Research And Treatment Of Cancer
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 20 Aug 2025 → ongoing
- Decision date (initial)
- 2024-09-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Immunocore Limited
External identifiers
- EU CT number
- 2023-510333-28-00
- ClinicalTrials.gov
- NCT06246149
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Therapy, Others
To prospectively assess whether adjuvant treatment with tebentafusp improves recurrence-free survival (RFS) as compared to observation.
Secondary objectives 2
- To prospectively assess whether adjuvant tebentafusp improves OS as compared to observation;
- To prospectively assess safety of adjuvant tebentafusp
Conditions and MedDRA coding
Uveal Melanoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10081431 | Uveal melanoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 14
- Pre-screening: Primary non-metastatic UM, except iris melanoma, after definitive treatment either by surgery or radiotherapy
- Pre-screening: Time from primary treatment smaller than 11 weeks (note that the maximum time between primary treatment and randomization is 12 weeks)
- 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
- Pre-screening: ECOG performance status of 0 or 1
- Pre-screening: 18 years or older
- Pre-screening: Written pre-screening informed consent according to ICH/GCP and local regulations
- Screening: HLA-A*02:01 positivity by local assessment
- Screening: No evidence of UM recurrence, as evidenced by the required baseline imaging performed within 4 weeks prior to randomization
- 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
- Screening: Time-interval between the end of primary treatment and the randomization less than or equal to 12 weeks
- 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.
- 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.
- 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.
- Screening: Written informed consent according to ICH/GCP and local regulations
Exclusion criteria 7
- 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
- Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to randomization
- 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.
- 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
- 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
- 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
- Known contraindication to imaging tracer or any product of contrast media and MRI and/or CT contraindications.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- RFS, defined as time between randomization and local recurrence, distant recurrence, or death, whichever occurs first.
Secondary endpoints 2
- OS, defined as time between randomization and death
- Safety of tebentafusp.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
KIMMTRAK 100 micrograms/0.5 mL concentrate for solution for infusion
PRD9617266 · Product
- Active substance
- Tebentafusp
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 68 µg microgram(s)
- Max total dose
- 1682 µg microgram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- NOTASSIGN — -
- Marketing authorisation
- EU/1/22/1630/001
- MA holder
- IMMUNOCORE IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2397
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
European Organisation For Research And Treatment Of Cancer
- Sponsor organisation
- European Organisation For Research And Treatment Of Cancer
- Address
- Emmanuel Mounierlaan 83 Bus 11
- City
- Sint-Lambrechts-Woluwe
- Postcode
- 1200
- Country
- Belgium
Scientific contact point
- Organisation
- European Organisation For Research And Treatment Of Cancer
- Contact name
- Stéphanie Kromar
Public contact point
- Organisation
- European Organisation For Research And Treatment Of Cancer
- Contact name
- Vassilis Golfinopoulos
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Institut Curie ORG-100009227
|
Paris, France | Other |
| Alcura Health Espana S.A. ORG-100020590
|
Viladecans, Spain | Code 14 |
| Azienda Ospedaliera Universitaria Integrata Verona ORG-100010372
|
Verona, Italy | Other |
| Cryoport France ORG-100040164
|
Clermont Ferrand, France | Other |
| Stichting EuroQol Research Foundation ORG-100048809
|
Rotterdam, Netherlands | Other |
| Radionix LLC ORG-100052492
|
Tenafly, United States | Other |
Locations
9 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 21 | 1 |
| France | Ongoing, recruiting | 24 | 4 |
| Germany | Ongoing, recruiting | 48 | 4 |
| Ireland | Authorised, recruitment pending | 6 | 1 |
| Italy | Authorised, recruitment pending | 24 | 3 |
| Netherlands | Ongoing, recruiting | 24 | 2 |
| Poland | Ongoing, recruiting | 15 | 1 |
| Spain | Ongoing, recruiting | 24 | 3 |
| Sweden | Authorised, recruiting | 14 | 1 |
| Rest of world
United States, United Kingdom
|
— | 110 | — |
Investigational sites
Cliniques Universitaires Saint-Luc
Oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre Jean Perrin
oncology, 58 Rue Montalembert, 63011, Clermont Ferrand Cedex1
Centre Antoine Lacassagne
Oncology, 33 Avenue De Valombrose, 06189, Nice Cedex 2
Institut Curie
Oncology, 26 Rue D Ulm, 75005, Paris
Centre De Lutte Contre Le Cancer Eugene Marquis
Medical Oncology, Avenue La Bataille Flandre Dunkerque, Cs 44229, Rennes Cedex
Universitaetsklinikum Heidelberg AöR
Hautklinik, Im Neuenheimer Feld 440, Neuenheim, Heidelberg
Charite Universitaetsmedizin Berlin KöR
Klinik fuer Haematologie, Onkologie und Tumorimmunologie, Hindenburgdamm 30, Lichterfelde, Berlin
Universitaetsklinikum Essen AöR
Medical Oncology, Hufelandstrasse 55, Holsterhausen, Essen
University Medical Center Hamburg-Eppendorf
Dermatology, Martinistrasse 52, Eppendorf, Hamburg
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Melanoma, Cancer Immunotherapy and Development Therapeutics, Via Mariano Semmola 52, 80131, Naples
Fondazione IRCCS Istituto Nazionale Dei Tumori
Medical Oncology, Via Giacomo Venezian 1, 20133, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncology, Largo Francesco Vito 1, 00168, Rome
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Oncology and Radiology & Nuclear Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Leids Universitair Medisch Centrum (LUMC)
Medical, Albinusdreef 2, 2333 ZA, Leiden
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oncology, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Clinico Universitario De Valladolid
Oncology, Avenida Ramon Y Cajal 3, 47003, Valladolid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Oncology, Avenida De Cordoba Sn, 28041, Madrid
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2025-04-03 | 2025-04-28 | |||
| France | 2024-11-27 | 2025-02-27 | |||
| Germany | 2024-11-12 | 2024-11-13 | |||
| Netherlands | 2025-02-07 | 2025-05-09 | |||
| Poland | 2024-12-05 | 2025-05-07 | |||
| Spain | 2025-05-23 | 2025-06-17 | |||
| Sweden | 2026-01-30 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 7 · Art. 38 CTR
Temporary halt TH-92727
- Halt date
- 2025-07-22
- Member states concerned
- Netherlands
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Immunocore, the Marketing Authorisation Holder, initiated a Class III voluntary recall of batch 3D009A of the investigational medicinal product IMCgp100 (Tebentafusp), due to an unexpected decrease in an in-vitro potency assay (EMA (QD2025-192/H/Defective Product Report)).
As a result, the sponsor (EORTC) has decided to temporarily halt recruitment until a new study-specific batch of Tebentafusp is made available at all participating sites. - Follow-up measures
- • 22 July 2025: All participating sites were formally notified of the temporary halt.
• A follow-up communication was sent to investigators, detailing:
The recall and prohibition of batch 3D009A use (to be quarantined and not used).
• Guidance for treatment continuity using:
Commercial IMP: Sites may use available commercial stock, if permitted by national/local regulations, until the new supply is delivered (expected by 05 August 2025).
New study-specific batch: Expected to be available by the end of August 2025.
• For patients already under treatment: switch to an alternative batch as per above.
• For patients registered but not yet randomized: randomization may proceed if commercial IMP use is permitted by national/local regulations.
Of note: the above measures do not concern Poland. The batch 3D009A recall in Poland is managed as per USM of 9 July 2025. Following the first 5 weeks indicated in the USM, the patient will continue receiving 6 more weeks of treatment coming from the same study mentioned in the USM: Tebentafusp from IMCgp100203 (TEBE AM).
• A notification to patients has been prepared in response to RFI UE-89129. It will be presented to all patients who received batch 3D009A.
• A guideline on patients’ management will be implemented immediately for patients under treatment and those in screening. This guideline will be included in the next protocol amendment and submitted via Substantial Modification on the CTIS portal. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92551
- Halt date
- 2025-07-22
- Member states concerned
- Spain
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Immunocore, the Marketing Authorisation Holder, initiated a Class III voluntary recall of batch 3D009A of the investigational medicinal product IMCgp100 (Tebentafusp), due to an unexpected decrease in an in-vitro potency assay (EMA (QD2025-192/H/Defective Product Report)).
As a result, the sponsor (EORTC) has decided to temporarily halt recruitment until a new study-specific batch of Tebentafusp is made available at all participating sites. - Follow-up measures
- • 22 July 2025: All participating sites were formally notified of the temporary halt.
• A follow-up communication was sent to investigators, detailing:
The recall and prohibition of batch 3D009A use (to be quarantined and not used).
• Guidance for treatment continuity using:
Commercial IMP: Sites may use available commercial stock, if permitted by national/local regulations, until the new supply is delivered (expected by 05 August 2025).
New study-specific batch: Expected to be available by the end of August 2025.
• For patients already under treatment: switch to an alternative batch as per above.
• For patients registered but not yet randomized: randomization may proceed if commercial IMP use is permitted by national/local regulations.
Of note: the above measures do not concern Poland. The batch 3D009A recall in Poland is managed as per USM of 9 July 2025. Following the first 5 weeks indicated in the USM, the patient will continue receiving 6 more weeks of treatment coming from the same study mentioned in the USM: Tebentafusp from IMCgp100203 (TEBE AM).
• A notification to patients has been prepared in response to RFI UE-89129. It will be presented to all patients who received batch 3D009A.
• A guideline on patients’ management will be implemented immediately for patients under treatment and those in screening. This guideline will be included in the next protocol amendment and submitted via Substantial Modification on the CTIS portal. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92554
- Halt date
- 2025-07-22
- Member states concerned
- Germany
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Immunocore, the Marketing Authorisation Holder, initiated a Class III voluntary recall of batch 3D009A of the investigational medicinal product IMCgp100 (Tebentafusp), due to an unexpected decrease in an in-vitro potency assay (EMA (QD2025-192/H/Defective Product Report)).
As a result, the sponsor (EORTC) has decided to temporarily halt recruitment until a new study-specific batch of Tebentafusp is made available at all participating sites. - Follow-up measures
- • 22 July 2025: All participating sites were formally notified of the temporary halt.
• A follow-up communication was sent to investigators, detailing:
The recall and prohibition of batch 3D009A use (to be quarantined and not used).
• Guidance for treatment continuity using:
Commercial IMP: Sites may use available commercial stock, if permitted by national/local regulations, until the new supply is delivered (expected by 05 August 2025).
New study-specific batch: Expected to be available by the end of August 2025.
• For patients already under treatment: switch to an alternative batch as per above.
• For patients registered but not yet randomized: randomization may proceed if commercial IMP use is permitted by national/local regulations.
Of note: the above measures do not concern Poland. The batch 3D009A recall in Poland is managed as per USM of 9 July 2025. Following the first 5 weeks indicated in the USM, the patient will continue receiving 6 more weeks of treatment coming from the same study mentioned in the USM: Tebentafusp from IMCgp100203 (TEBE AM).
• A notification to patients has been prepared in response to RFI UE-89129. It will be presented to all patients who received batch 3D009A.
• A guideline on patients’ management will be implemented immediately for patients under treatment and those in screening. This guideline will be included in the next protocol amendment and submitted via Substantial Modification on the CTIS portal. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92556
- Halt date
- 2025-07-22
- Member states concerned
- France
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Immunocore, the Marketing Authorisation Holder, initiated a Class III voluntary recall of batch 3D009A of the investigational medicinal product IMCgp100 (Tebentafusp), due to an unexpected decrease in an in-vitro potency assay (EMA (QD2025-192/H/Defective Product Report)).
As a result, the sponsor (EORTC) has decided to temporarily halt recruitment until a new study-specific batch of Tebentafusp is made available at all participating sites. - Follow-up measures
- • 22 July 2025: All participating sites were formally notified of the temporary halt.
• A follow-up communication was sent to investigators, detailing:
The recall and prohibition of batch 3D009A use (to be quarantined and not used).
• Guidance for treatment continuity using:
Commercial IMP: Sites may use available commercial stock, if permitted by national/local regulations, until the new supply is delivered (expected by 05 August 2025).
New study-specific batch: Expected to be available by the end of August 2025.
• For patients already under treatment: switch to an alternative batch as per above.
• For patients registered but not yet randomized: randomization may proceed if commercial IMP use is permitted by national/local regulations.
Of note: the above measures do not concern Poland. The batch 3D009A recall in Poland is managed as per USM of 9 July 2025. Following the first 5 weeks indicated in the USM, the patient will continue receiving 6 more weeks of treatment coming from the same study mentioned in the USM: Tebentafusp from IMCgp100203 (TEBE AM).
• A notification to patients has been prepared in response to RFI UE-89129. It will be presented to all patients who received batch 3D009A.
• A guideline on patients’ management will be implemented immediately for patients under treatment and those in screening. This guideline will be included in the next protocol amendment and submitted via Substantial Modification on the CTIS portal. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-89924
- Halt date
- 2025-07-04
- Member states concerned
- Poland
- Publication date
- 2025-07-11
- Reason
- Medicinal Product related
- Explanation
- The site has one patient under treatment. The patient had a scheduled visit on 3 July 2025; however, the Hospital Pharmacy confirmed that the study drug batch could not be released for patient use, in line with the notification received from the Polish Authorities. Consequently, the planned dosing could not take place.
On 11 June 2025, Immunocore (MAH) informed the EORTC about the medical / health hazard assessment leading to the voluntary and precautionary Class III recall of Kimmtrak drug product batch 3D009A and EORTC did declare it as an unexpected event via CTIS. However, EORTC has not been notified by Immunocore about decision of Polish regulators, although they received the notification on 24 June 2025 from the Chief Pharmaceutical Inspector of Poland. - Follow-up measures
- The patient was treated on 9th of July and for the next 5 weeks with Tebentafusp from IMCgp100-203 (TEBE AM) study which is conducted at the same site. Certain identified IMCgpl00 vials will be transferred from the IMCgpl00-203 (TEBE AM) study for patient treatment on the EORTC-2022-MG (ATOM) study.
To maintain continuity of patient care, IMCgpl00 stock labelled for IMCgpl00-203 (TEBE AM) and drug product batch 4A010A will be used for a patient on EORTC-2022-MG. This use will only occur until the new supply of properly labelled IMCgpl00 for EORTC-2022-MG is on site and ready for clinical use. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92559
- Halt date
- 2025-07-22
- Member states concerned
- Belgium
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Immunocore, the Marketing Authorisation Holder, initiated a Class III voluntary recall of batch 3D009A of the investigational medicinal product IMCgp100 (Tebentafusp), due to an unexpected decrease in an in-vitro potency assay (EMA (QD2025-192/H/Defective Product Report)).
As a result, the sponsor (EORTC) has decided to temporarily halt recruitment until a new study-specific batch of Tebentafusp is made available at all participating sites. - Follow-up measures
- • 22 July 2025: All participating sites were formally notified of the temporary halt.
• A follow-up communication was sent to investigators, detailing:
The recall and prohibition of batch 3D009A use (to be quarantined and not used).
• Guidance for treatment continuity using:
Commercial IMP: Sites may use available commercial stock, if permitted by national/local regulations, until the new supply is delivered (expected by 05 August 2025).
New study-specific batch: Expected to be available by the end of August 2025.
• For patients already under treatment: switch to an alternative batch as per above.
• For patients registered but not yet randomized: randomization may proceed if commercial IMP use is permitted by national/local regulations.
Of note: the above measures do not concern Poland. The batch 3D009A recall in Poland is managed as per USM of 9 July 2025. Following the first 5 weeks indicated in the USM, the patient will continue receiving 6 more weeks of treatment coming from the same study mentioned in the USM: Tebentafusp from IMCgp100203 (TEBE AM).
• A notification to patients has been prepared in response to RFI UE-89129. It will be presented to all patients who received batch 3D009A.
• A guideline on patients’ management will be implemented immediately for patients under treatment and those in screening. This guideline will be included in the next protocol amendment and submitted via Substantial Modification on the CTIS portal. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-92548
- Halt date
- 2025-07-22
- Member states concerned
- Netherlands
- Publication date
- 2025-07-31
- Reason
- Medicinal Product related
- Explanation
- Immunocore, the Marketing Authorisation Holder, initiated a Class III voluntary recall of batch 3D009A of the investigational medicinal product IMCgp100 (Tebentafusp), due to an unexpected decrease in an in-vitro potency assay (EMA (QD2025-192/H/Defective Product Report)).
As a result, the sponsor (EORTC) has decided to temporarily halt recruitment until a new study-specific batch of Tebentafusp is made available at all participating sites. - Follow-up measures
- • 22 July 2025: All participating sites were formally notified of the temporary halt.
• A follow-up communication was sent to investigators, detailing:
The recall and prohibition of batch 3D009A use (to be quarantined and not used).
• Guidance for treatment continuity using:
Commercial IMP: Sites may use available commercial stock, if permitted by national/local regulations, until the new supply is delivered (expected by 05 August 2025).
New study-specific batch: Expected to be available by the end of August 2025.
• For patients already under treatment: switch to an alternative batch as per above.
• For patients registered but not yet randomized: randomization may proceed if commercial IMP use is permitted by national/local regulations.
Of note: the above measures do not concern Poland. The batch 3D009A recall in Poland is managed as per USM of 9 July 2025. Following the first 5 weeks indicated in the USM, the patient will continue receiving 6 more weeks of treatment coming from the same study mentioned in the USM: Tebentafusp from IMCgp100203 (TEBE AM).
• A notification to patients has been prepared in response to RFI UE-89129. It will be presented to all patients who received batch 3D009A.
• A guideline on patients’ management will be implemented immediately for patients under treatment and those in screening. This guideline will be included in the next protocol amendment and submitted via Substantial Modification on the CTIS portal. - Benefit-risk balance changed
- No
- Treatment stopped
- No
Urgent safety measures 1 · Art. 54 CTR
Urgent safety measure US-92579
- Event date
- 2025-07-22
- Submission date
- 2025-08-06
- In response to
- OTHER
- Member states affected
- Belgium, France, Germany, Italy, Spain, Netherlands, Poland, Ireland, Sweden
- Event description
- Immunocore, the Marketing Authorisation Holder, initiated a Class III voluntary recall of batch 3D009A of the investigational medicinal product IMCgp100 (Tebentafusp), due to an unexpected decrease in an in-vitro potency assay (EMA (QD2025-192/H/Defective Product Report)).
As a result, the sponsor (EORTC) has decided to temporarily halt recruitment until a new study-specific batch of Tebentafusp is made available at all participating sites.
Please note that due to technical issues related to this study in CTIS, the USM was declared via email on 28 July. As soon as we were aware of the resolution of the situation we proceeded with the submission on CTIS without delay. - Measures taken
- • 22 July 2025: All participating sites were formally notified of the temporary halt.
• A follow-up communication was sent to investigators, detailing:
The recall and prohibition of batch 3D009A use (to be quarantined and not used).
• Guidance for treatment continuity using:
Commercial IMP: Sites may use available commercial stock, if permitted by national/local regulations, until the new supply is delivered (expected by 05 August 2025).
New study-specific batch: Expected to be available by the end of August 2025.
• For patients already under treatment: switch to an alternative batch as per above.
• For patients registered but not yet randomized: randomization may proceed if commercial IMP use is permitted by national/local regulations.
Of note: the above measures do not concern Poland. The batch 3D009A recall in Poland is managed as per USM of 9 July 2025. Following the first 5 weeks indicated in the USM, the patient will continue receiving 6 more weeks of treatment coming from the same study mentioned in the USM: Tebentafusp from IMCgp100203 (TEBE AM).
• A notification to patients has been prepared in response to RFI UE-89129. It will be presented to all patients who received batch 3D009A.
• A guideline on patients’ management will be implemented immediately for patients under treatment and those in screening. This guideline will be included in the next protocol amendment and submitted via Substantial Modification on the CTIS portal. - Justification
- We resubmitted the attached documents, as they were not saved due to technical issues, despite having been originally submitted via CTIS on 31 July 2025 .
Unexpected events 1 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-89129
- Event date
- 2025-06-10
- Date aware
- 2025-06-11
- Submission date
- 2025-07-03
- Member states affected
- Belgium, France, Germany, Italy, Spain, Netherlands, Poland, Ireland, Sweden
- Event description
- Medical / health hazard assessment related to lower potency in drug product batch 3D009A
This medical / health hazard assessment is with reference to the voluntary and precautionary Class III recall of Kimmtrak drug product batch 3D009A initiated by Immunocore on June 10, 2025.
The reason for recall was due to an unexpected decrease in an in vitro potency assay in this one batch which was determined as part of routine stability testing. All other stability test results remain within specification. No other batches are affected.
•Safety
To date, no patient safety issue has been identified or is expected
•Efficacy
Based on all available data to date, we do not believe there will be a material impact on KIMMTRAK (tebentafusp) activity
•Continuity of care
Patients should continue being initiated and treated with impacted batch doses, rather than forego treatment, until an alternative Kimmtrak drug product batch is available.
Please find attached the original communication received from Immunocore.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 83 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-510333-28-00_Redacted | 5.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L BE_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L BE_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L DE_DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L ES_ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L FR_FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L IT_IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L NL_NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L PL_PL | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire EQ-5D-5L SE | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire QLQ-C30 and IL297 DE | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire QLQ-C30 and IL297 EN | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire QLQ-C30 and IL297 ES | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire QLQ-C30 and IL297 FR | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire QLQ-C30 and IL297 IT | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire QLQ-C30 and IL297 NL | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire QLQ-C30 and IL297 PL | 3.0 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire QLQ-C30 and IL297 SE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_tc | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_tc | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_tc | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_tc | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Enrolment_ES | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF PIS Enrolment_tc | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Pre-screening_ES | 1 |
| Subject information and informed consent form (for publication) | L1_GP letter | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient Card_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_Patient Card_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biobank | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Biobank_tc | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrollment_tc | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_BE NL | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_FR | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_FR | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_FR_tc | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_NL_tc | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_SE | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_tc | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_tc | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_tc | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Enrolment_tc | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_BE NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_FR_tc | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_NL_tc | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_SE | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_tc | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_tc | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_tc | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pre-screening_tc | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Partner_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Partner_NL | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC KIMMTRAK | 1 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol summary_EN 2023-510333-28-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR 2023-510333-28-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL 2023-510333-28-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE 2023-510333-28-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2023-510333-28-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2023-510333-28-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2023-510333-28-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL 2023-510333-28-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2023-510333-28-00 | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE_2023-510333-28-00 | 5.0 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-29 | Belgium | Acceptable with conditions 2024-09-18
|
2024-09-18 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-02 | Acceptable with conditions 2024-09-18
|
2024-12-02 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-03 | Belgium | Acceptable with conditions 2024-09-18
|
2024-12-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Belgium | Acceptable with conditions | 2025-01-21 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-11 | Acceptable with conditions | 2025-04-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-11 | Acceptable with conditions | 2025-05-14 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-11 | Acceptable with conditions | 2025-05-06 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-04-04 | Acceptable with conditions | 2025-07-10 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-06-24 | Acceptable with conditions 2024-09-18
|
2025-09-19 | |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2025-07-01 | Acceptable with conditions 2024-09-18
|
2025-08-19 | |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-09-25 | Acceptable with conditions 2024-09-18
|
2025-09-25 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-11-07 | Acceptable with conditions | 2025-12-15 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-06 | Belgium | Acceptable 2026-05-11
|
2026-05-11 |