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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first dose to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose to approximately 2 years
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 moreTrial 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
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a serious allergic reaction to a different kind of antibody treatment before.I cannot receive pembrolizumab again due to a past side effect.My melanoma cannot be removed with surgery and is advanced.My condition has not worsened after treatment with an anti-PD(L)1 mAb.I have provided a sample of my tumor, either from stored tissue or a new biopsy.I have never been treated with ipilimumab.I have an autoimmune disease needing treatment and significant heart issues.My cancer has a BRAF V600 mutation and I haven't had BRAF/MEK inhibitors.I am fully active or restricted in physically strenuous activity but can do light work.You have a disease that can be measured or observed using a specific medical guideline called RECIST 1.1.Your lab test results are not within the normal range.I've been treated with an ImmTAC medication but haven't completed the washout period.I haven't taken steroids or immunosuppressants in the last 2 weeks.I have a history of chronic hepatitis B or C.I have had a transplant of an organ or tissue from another person.I have untreated brain metastases or cancer in my brain's lining.I have side effects from treatment that are moderate to severe.I have been diagnosed with a type of eye cancer called uveal melanoma.I have had cancer other than the one being treated in this study.I have the HLA-A*02:01 gene.I haven't had certain cancer treatments in the last 14 days.I have not had cell therapy in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C
- Group 2: Arm A
- Group 3: Arm B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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