Study Comparing Tebentafusp Treatment to Other Options in Previously Treated Advanced Melanoma

Sponsor: Immunocore Ltd

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05549297

Provider View

This clinical trial is testing the effectiveness and safety of a new treatment called tebentafusp, either alone or with another drug, pembrolizumab, compared to other standard treatments or supportive care in patients with advanced melanoma that is not in the eye.

Patient Parameters

Program Overview

The study aims to find out if tebentafusp, used alone or with pembrolizumab, is better at treating advanced melanoma that has already been treated with other therapies. It compares these treatments to the usual care options available, including other clinical trials, standard therapies, or supportive care.

Description

This trial is a Phase 2/3 study conducted at multiple centers. It is open-label, meaning both the researchers and participants know which treatment is being given. The study is testing tebentafusp as a single treatment (Arm A) and in combination with pembrolizumab (Arm B) against standard care or supportive care (Arm C) in patients with advanced melanoma that is not in the eye. Participants must have previously been treated with anti-PD(L)1 therapy, ipilimumab, and, if they have a BRAF mutation, a BRAF inhibitor.

Eligibility Criteria

Inclusion Criteria

  • Must have a specific genetic marker called HLA-A*02:01.
  • Have advanced melanoma that cannot be removed by surgery and is not in the eye.
  • Provide a tumor sample from a biopsy or previous surgery.
  • Have cancer that can be measured or tracked by doctors.
  • Be in good overall health with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Agree to use effective birth control if applicable.
  • Be able to understand and sign a consent form agreeing to the study's requirements.
  • Agree to provide samples for research purposes.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have melanoma in the eye or a specific type called uveal melanoma.
  • Have had another type of cancer not being treated in this study.
  • Cannot be treated again with pembrolizumab due to previous side effects.
  • Have untreated or symptomatic brain cancer or cancer in the brain's lining.
  • Have had severe allergic reactions to similar treatments.
  • Have active autoimmune diseases needing treatment or serious heart problems.
  • Have mental health or substance abuse issues.
  • Have taken certain immune therapies recently without a break.
  • Have had chemotherapy or biological therapy recently.
  • Have had cell-based therapies recently.
  • Have ongoing significant side effects from previous treatments.
  • Have used steroids or immunosuppressive drugs recently.
  • Have not progressed on anti-PD(L)1 treatment.
  • Have not received ipilimumab before.
  • Have a BRAF mutation but have not been treated with BRAF/MEK inhibitors.
  • Are in another clinical trial or using an investigational device recently.
  • Have chronic viral infections like hepatitis B or C.
  • Have abnormal lab results.
  • Have had a tissue or organ transplant.

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