Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma

Sponsor
University of Oxford
Study ID
NCT05315258
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Melanoma (Skin)
  • Melanoma, Uveal

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tebentafusp — DRUG
    Tebentafusp supplied as concentrate for solution for infusion and diluted prior to administration. 0.2 mg/mL drug product will be provided as a sterile, refrigerated solution in glass vials.

Study Details

Researchers are trying to find ways to improve the management of people with intermediate or high risk resected cutaneous melanoma or with primary uveal melanoma. This research study is investigating using a new blood test to decide when to give a drug called tebentafusp. Tebentafusp has been used in clinical trials in patients with advanced cutaneous and uveal melanoma. This study is designed to determine if tebentafusp can help patients with cutaneous or uveal melanoma live longer.

Key Dates

Start date
Jul 25, 2022
Status verified
Jul 2025
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
850 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Cutaneous melanoma with molecular relapsed disease
    tebentafusp weekly IV escalating in the first treatment cycle with dose 20 mcg on day 1, 30 mcg on day 8, 68 mcg on days 15 and 22. Thereafter weekly doses will be 68 mcg IV for 6 months.
  • Experimental: Uveal melanoma with molecular relapsed disease
    tebentafusp weekly IV escalating in the first treatment cycle with dose 20 mcg on day 1, 30 mcg on day 8, 68 mcg on days 15 and 22. Thereafter weekly doses will be 68 mcg IV for 6 months.

Primary Outcome Measure

Estimate the rate of molecular response (MR) to tebentafusp in each of 2 cohorts A. Cutaneous melanoma with MRD B. Uveal melanoma with MRD [ Time Frame: ctDNA taken at baseline until end of treatment (maximum of 6 months) ]

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