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Looking for participantsPhase3

Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

Sponsor: Immunocore Ltd

NCT ID: NCT05549297

View on ClinicalTrials.gov ↗

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.

Advanced Melanoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

BRAF

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
Inclusion Criteria: * 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-measurable disease per RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * If applicable, must agree to use highly effective contraception * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol * Must agree to provide protocol specified samples for biomarker analyses. Exclusion Criteria: * Pregnant or lactating women * diagnosis of ocular or metastatic 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 symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis * previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb) * active autoimmune disease requiring immunosuppressive treatment * known psychiatric or substance abuse disorders * received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication or who have not completed adequate washout from prior medications. * received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose * received cellular therapies within 90 days of study intervention * ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically significant who in the opinion of the investigator could affect the outcome of the study * received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose * have not progressed on treatment with an anti-PD(L)1 mAb * have not received prior treatment with an approved anti-CTLA-4 mAb * have a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen * currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose * known history of chronic viral infections such as hepatitis B virus (HBV) or hepatitis C virus (HCV) * known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function * Out of range Laboratory values * history of allogenic tissue/solid organ transplant

Where Is This Study? (9 UK sites)

Addenbrooke's Hospital

Cambridge CB2 0QQ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Stephen Kelleher

cuh.research@nhs.net01223 348490

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

Queen Elizabeth Hospital

Birmingham B15 2TH, United Kingdom

Recruiting
Hospital R&D contact (matched)

Tom Dymond

research&development@qehkl.nhs.uk01553 613532

Leeds General Infirmary

Leeds LS1 3EX, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Guys & St Thomas' NHS Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.RandD@nhs.net

gstt.RandD@nhs.net---

Sarah Cannon Research Institute UK

London SE1 9RT, United Kingdom

Recruiting

Royal Marsden Hospital - Chelsea

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

Mount Vernon Cancer Center

Middlesex HA6 2RN, United Kingdom

Recruiting

Royal Marsden Hospital - Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Immunocore Medical Information

Sponsor contact

CONTACT

844-466-8661 medical.information@immunocore.com

Immunocore Medical Information EU

Sponsor contact

CONTACT

+00 800-744-51111 medinfo.eu@immunocore.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-02