Informations générales (source: ClinicalTrials.gov)
Adjuvant Tebentafusp (IMCgp100) Versus Observation in HLA-A*02:01 Positive Patients Following Definitive Treatment of High-risk Uveal Melanoma: an EORTC Randomized Phase III Study (ATOM Trial) (ATOM)
Interventional
Phase 3
European Organisation for Research and Treatment of Cancer - EORTC (Voir sur ClinicalTrials)
novembre 2024
novembre 2032
13 décembre 2024
At least 50% of patients with high-risk primary uveal melanoma will develop a recurrence
following treatment of the primary tumour. Observation is currently the standard of care
in the non-metastatic setting. Tebentafusp is the first agent proven to improve overall
survival in patients with metastatic uveal melanoma in a randomized trial. Based on the
results in the advanced setting, it is hypothesized that treatment with tebentafusp may
reduce the risk of development of disease recurrence.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/12/2024 12:44:10 | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Primary non-metastatic UM, except iris melanoma, after definitive treatment either
by surgery or radiotherapy
- Time from primary treatment smaller than 11 weeks (note that the maximum time
between primary treatment and randomization is 12 weeks )
- 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.
- ECOG performance status of 0 or 1
- 18 years or older
- HLA-A*02:01 positivity by local assessment
- No evidence of UM recurrence, as evidenced by the required baseline imaging
performed within 4 weeks prior to randomization
- Adequate organ function
- Time-interval between the end of primary treatment and the randomization less than
or equal to 12 weeks
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for
women of childbearing potential (WOCBP) within 3 days prior to randomization.
- 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.
- 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.
- Written informed consent according to ICH/GCP and local regulations
- Primary non-metastatic UM, except iris melanoma, after definitive treatment either
by surgery or radiotherapy
- Time from primary treatment smaller than 11 weeks (note that the maximum time
between primary treatment and randomization is 12 weeks )
- 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.
- ECOG performance status of 0 or 1
- 18 years or older
- HLA-A*02:01 positivity by local assessment
- No evidence of UM recurrence, as evidenced by the required baseline imaging
performed within 4 weeks prior to randomization
- Adequate organ function
- Time-interval between the end of primary treatment and the randomization less than
or equal to 12 weeks
- Evidence of post-menopausal status or negative urinary or serum pregnancy test for
women of childbearing potential (WOCBP) within 3 days prior to randomization.
- 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.
- 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.
- Written informed consent according to ICH/GCP and local regulations
- 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. NOTE: testing for HIV, HBV, and HCV status prior to enrolment is
not necessary unless clinically indicated.
- 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