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Immunotherapy

Tebentafusp for Advanced Melanoma

Phase 2 & 3
Recruiting
Research Sponsored by Immunocore Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Unresectable Stage III or Stage IV non-ocular melanoma
Archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first dose to approximately 2 years
Awards & highlights

Study Summary

This trial evaluates if a new drug is better than current treatments for advanced melanoma.

Who is the study for?
This trial is for adults with advanced non-ocular melanoma who are HLA-A*02:01-positive, have a good performance status (able to carry out daily activities), and can provide a tumor tissue sample. They must not be pregnant or breastfeeding, have no history of other cancers or severe psychiatric disorders, and cannot currently be in another clinical study.Check my eligibility
What is being tested?
The trial tests Tebentafusp alone or combined with Pembrolizumab against treatments chosen by the investigator, which could include standard care or supportive measures. It aims to see how well these tebentafusp-based regimens work and their safety compared to current options.See study design
What are the potential side effects?
Tebentafusp may cause immune-related reactions, fatigue, skin issues, fever-like symptoms and possibly affect liver function. When combined with Pembrolizumab, there might also be risks of inflammation in organs like lungs or intestines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma cannot be removed with surgery and is advanced.
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I have provided a sample of my tumor, either from stored tissue or a new biopsy.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have the HLA-A*02:01 gene.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose to approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2 Primary
Secondary outcome measures
Phase 2 Secondary
Safety: Adverse Events and Severe Adverse Events
Safety: Tolerability
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm CExperimental Treatment1 Intervention
Straight to on protocol survival follow up including investigators choice of therapy
Group II: Arm BExperimental Treatment1 Intervention
Tebentafusp in combination with Pembrolizumab
Group III: Arm AExperimental Treatment1 Intervention
Tebentafusp as single agent

Find a Location

Who is running the clinical trial?

Immunocore LtdLead Sponsor
13 Previous Clinical Trials
2,752 Total Patients Enrolled
9 Trials studying Melanoma
2,298 Patients Enrolled for Melanoma
Mohammed Dar, MDStudy DirectorImmunocore Ltd
3 Previous Clinical Trials
566 Total Patients Enrolled
2 Trials studying Melanoma
491 Patients Enrolled for Melanoma

Media Library

Tebentafusp (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05549297 — Phase 2 & 3
Melanoma Research Study Groups: Arm C, Arm A, Arm B
Melanoma Clinical Trial 2023: Tebentafusp Highlights & Side Effects. Trial Name: NCT05549297 — Phase 2 & 3
Tebentafusp (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05549297 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still available spots in this exploration of treatments?

"As published on clinicaltrials.gov, this research is actively searching for suitable candidates. The trial was posted in December of 2022 and the information has been updated as recently as February 2021."

Answered by AI

What is the scope of recruitment for this research endeavor?

"Affirmative. The research posted on clinicaltrials.gov reveals that this medical trial is actively looking for applicants, with the initial posting being on December 19th 2022 and an update occurring as recently as February 21st 2023. 460 participants must be enrolled from 2 different sites."

Answered by AI
~307 spots leftby Dec 2026