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RecruitingLast updated: 28 March 2024

TEBE-AM: This study is evaluating the safety and efficacy of immunotherapy (called tebentafusp) based treatments, when given alone or in combination with another type of immunotherapy (called pembrolizumab), compared to standard of care treatment, in people with advanced melanoma who have progressed on prior treatmentPhase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma

Clinical summary


Eligible participants will be randomly allocated to one of three treatment arms. 

In Arm A, participants will receive tebentafusp, a type of immunotherapy, by itself.

In Arm B, participants will receive tebentafusp in combination with pembrolizumab immunotherapy.

In Arm C, participants will receive Investigator's choice of standard treatment. 


This trial is treating patients with HLA-A*02:01-positive, non-ocular melanoma who have progressed on prior treatment


Skin Cancers Skin





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Trial Identifiers

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Trial sponsor

Immunocore Ltd

Scientific Title

Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma



  • 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.


  • 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 with clinically significant cardiac disease or impaired cardiac function
  • known psychiatric or substance abuse disorders
  • received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication 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 ipilimumab
  • 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)
  • Out of range Laboratory values
  • history of allogenic tissue/solid organ transplant


  • You have had a certain type of treatment or surgical procedure.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.


  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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