A Phase 2/3 Study of Tebentafusp Alone or With Pembrolizumab Immunotherapy Versus Standard Treatment in People With Previously Treated Melanoma

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Full Title

A Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination with Pembrolizumab Versus Investigator’s Choice in HLA-A*02:01-positive Patients with Previously Treated Advanced Melanoma (TEBE-AM)

Purpose

Researchers want to see if giving tebentafusp alone or with pembrolizumab is better than standard treatment for advanced melanoma. People in this study have melanoma that keeps growing even after treatment. Their melanoma also contains an immune system protein called HLA type A*0201.

Tebentafusp works to help your immune system fight cancer. Pembrolizumab also works by boosting the immune system to find and kill cancer cells. Both drugs are given intravenously (by vein). If you join this study, you will be randomly assigned to get one of these treatments.

  • Tebentafusp alone
  • Tebentafusp plus pembrolizumab
  • Another treatment chosen by your doctor

Who Can Join

To join this study, there are a few conditions. You must:

  • Have stage 3 or 4 melanoma that has grown even with immunotherapy. If you have melanoma with a mutation called BRAF V600, the cancer must have grown even with targeted therapy.
  • Have the HLA type A*0201 protein. We will test for this protein at Memorial Sloan Kettering.
  • Be willing to get tebentafusp treatment once a week.
  • Have recovered from the serious side effects of previous treatments before getting the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information and to see if you can join this study, please call Dr. Alexander Shoushtari’s office 646-888-4161.

Protocol

23-087

Phase

Phase II/III (phases 2 and 3 combined)

Disease Status

Relapsed or Refractory
Margaret Callahan

Diseases

ClinicalTrials.gov ID

NCT05549297