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Adjuvant Tebentafusp in High Risk Ocular Melanoma

ConditionUveal Melanoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tebentafusp

    Drug

    Tebentafusp will be administered weekly i.v.

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: TebentafuspExperimental treatment 1 intervention
Group B: ObservationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Recurrence-Free survival (RFS)

RFS is defined as the time between randomization and local recurrence, distant recurrence, or death, whichever occurs first

Time frame
8.1 years from first patient in

Secondary outcomes

1

Overall Survival (OS)

OS is defined as the time between randomization and death

Time frame
8.1 years from first patient in
2

Occurrence of Adverse Events

This study will use the International Common Terminology Criteria for Adverse Events (CTCAE), version 4.0, for adverse event reporting

Time frame
8.1 years from first patient in
3

Health-related Quality of Life

It will be evaluated using self-administered EORTC QLQ-C30 questionnaire

Time frame
8.1 years from first patient in

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Organisation for Research and Treatment of Cancer - EORTC

Lead sponsor

Northwell Health

Collaborator

Immunocore Ltd

Collaborator

Source ClinicalTrials.gov
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