At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Tebentafusp (drug), Tebentafusp with Pembrolizumab (drug), Investigators Choice (drug)
- How long the study runs
- Study runs about 67 months (dates as stated)
- About the drug or intervention
- Tebentafusp — drug: Soluble gp100-specific T cell receptor with anti-CD3 scFV · Tebentafusp with Pembrolizumab — drug: Soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with pembrolizumab · Investigators Choice — drug: Investigators choice of therapy
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called TEBE-AM, is looking at a treatment called tebentafusp for people with advanced melanoma (a serious form of skin cancer) that has already been treated. It compares tebentafusp with a treatment chosen by the study doctor. It is paid for (sponsored) by Immunocore Ltd.
Who can take part
- Adults with advanced melanoma (stage III that cannot be removed by surgery, or stage IV) that is not in the eye
- A positive test for a marker called HLA-A*02:01
- Able to provide a stored tumour sample or a new biopsy (small piece of tissue) from a tumour that has not had radiotherapy
- Disease that can be measured or seen on scans using standard guidelines (RECIST 1.1)
- Fairly well and able to carry out normal activities (performance status score of 0 or 1)
- Willing to use highly effective contraception, if this applies
- Able to give informed consent and follow the study rules
- Willing to give samples for biomarker tests (tests on your body's markers)
- Have already had treatment with an approved anti-PD(L)1 medicine (a type of immunotherapy) and an approved anti-CTLA-4 medicine, and your cancer got worse on the anti-PD(L)1 treatment
- If you have a BRAF V600 gene change, you must have already had treatment with BRAF/MEK medicines
Who may not be able to
- Melanoma in the eye, or cancer that has spread from the eye (uveal melanoma)
- Pregnant or breastfeeding
- Another cancer in the past, apart from the one being treated in this study
- Not able to have pembrolizumab again because of side effects
- Untreated or symptom-causing cancer spread to the brain or spinal cord, or cancer in the lining of the brain and spine
- A severe allergic reaction to a monoclonal antibody (a type of medicine) before
- An active autoimmune disease needing treatment that dampens down the immune system
- Certain mental health or substance use problems
- Previous treatment with an ImmTAC medicine (the type of medicine being studied), or not enough time has passed since certain earlier treatments
- Chemotherapy or biological cancer therapy within 14 days before the first study dose (with some exceptions)
- Cell-based therapy within 90 days before the study treatment
- Ongoing side effects of grade 2 or worse that could affect the study results
- Steroids or other immune-dampening drugs within 2 weeks before the first dose
- Taking part in another study of an experimental drug or device within 30 days before the first dose
- Long-term viral infections such as hepatitis B or hepatitis C
- Serious lung or heart problems, or poor lung or heart function
- Blood test results outside the allowed range
- Previous transplant of tissue or an organ from another person
What taking part involves
- • Taking tebentafusp, or a treatment chosen by your study doctor (the details of how the treatments are given are not stated — ask the trial team)
- • Providing blood or tissue samples for biomarker testing
Time commitment: How long the study lasts and how many hospital visits are needed is not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 540
- Started
- 2022-12-19
- Last checked
- 2026-02
Plain English Summary
What is this study?
- • Testing a new treatment for advanced melanoma
- • Phase3 - 540 participants
- • The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \[SoC\], best supportive care \[BSC\] on protocol survivor follow up) in patients with advanced non-ocular melanoma
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced melanoma
Where?
- • Cambridge - Addenbrooke's Hospital
- • Manchester - The Christie NHS Foundation Trust
- • Birmingham - Queen Elizabeth Hospital
- • Leeds - Leeds General Infirmary
- • +5 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care \[SoC\], best supportive care \[BSC\] on protocol survivor follow up) in patients with advanced non-ocular melanoma.
More detail
This is a phase 3 (as upon conversion to phase 3 there were no changes to the arms listed herein), multicenter, open-label study to evaluate the efficacy and safety of tebentafusp as monotherapy (Arm A) and in combination with pembrolizumab (Arm B) compared with standard of care or best supportive care (Arm C) in participants with non-ocular advanced melanoma who have progressed on a prior anti-PD(L)1 regimen, received an approved anti-CTLA4 regimen and, if the participant has a BRAF mutation, a prior BRAF tyrosine kinase inhibitor (TKI) regimen.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓HLA-A\*02:01-positive
- ✓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.
- ✓measurable or non-cancer that can be measured on scans 1.1
- ✓activity scale (ECOG) performance status score of 0 or 1
Who cannot take part
- ✗Pregnant or lactating women
- ✗diagnosis of ocular or that has spread uveal melanoma
- ✗history of a malignant disease other than those being treated in this study
- ✗ineligible to be retreated with pembrolizumab due to a treatment-related AE
- ✗known untreated or causing symptoms central nervous system (CNS) metastases and/or carcinomatous meningitis
See the full criteria
Where Is This Study? (9 UK sites)
Addenbrooke's Hospital
Cambridge CB2 0QQ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Queen Elizabeth Hospital
Birmingham B15 2TH, United Kingdom
Leeds General Infirmary
Leeds LS1 3EX, United Kingdom
Guys & St Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
Sarah Cannon Research Institute UK
London SE1 9RT, United Kingdom
Royal Marsden Hospital - Chelsea
London SW3 6JJ, United Kingdom
Mount Vernon Cancer Center
Middlesex HA6 2RN, United Kingdom
Royal Marsden Hospital - Sutton
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Immunocore Medical Information
Sponsor contactCONTACT
Immunocore Medical Information EU
Sponsor contactCONTACT
