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Tebentafusp-Tebn · 1 trial · 1 indication
Regression is defined as ≥ 20% reduction in tumor volume. All estimates of rates will be presented with corresponding 95% exact confidence intervals. For regression rate, the method of Atkinson and Brown will be used to allow for the two-stage design.
| Arm | Type | Description |
|---|---|---|
| Neoadjuvant Tebentafusp in Patients Locally Advanced, Unresectable Primary Uveal Melanoma | EXPERIMENTAL | Tebentafusp administration: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter. Eye evaluations including clinical examination, ophthalmic ultrasound, optical coherence tomography, and wide-angle fundus imaging will be performed at baseline, Cycle 1 day 1, Cycle 1 day 8, Cycle 2 day 1, prior to definitive treatment for primary uveal melanoma (post-Tebentafusp), and at post-eye treatment evaluation at 3 months. Additionally optical coherence tomography angiography, autofluorescence, fluorescein angiography and MRI orbit will be performed at baseline, post-tebentafusp, and at post-eye treatment evaluation. Blood circulating tumor-derived DNA will be performed at baseline, Cycle 2 day 1, post-Tebentafusp, and at post-eye treatment evaluation at 3 months. Primary eye tumor biopsy (collected by fine-needle aspiration) and aqueous circulating tumor-derived DNA will be performed at baseline and post-Tebentafusp. |
| Name | Type | Description |
|---|---|---|
| Tebentafusp-Tebn | DRUG | Tebentafusp will be administered as follows: 20mcg on Day 1, 30mcg on Day 8, 68 mcg on Day 15, and weekly doses of 68 mcg thereafter. |
Inclusion Criteria: Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: 1. Male or female patient age ≥ 18 years of age at the time of informed consent. 2. Ability to provide and understand written informed consent prior to any study p...
Tebentafusp-Tebn is an investigational therapy being studied for the treatment of locally advanced unresectable uveal melanoma, a rare eye cancer. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial to assess its safety and efficacy in this patient population.
Tebentafusp-Tebn is being developed by Immunocore Holdings plc, a biopharmaceutical company traded on the stock exchange under the ticker symbol IMCR. The company is conducting clinical trials to evaluate the drug's potential as a treatment for locally advanced unresectable uveal melanoma.
Tebentafusp-Tebn is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval for commercial use. The ongoing Phase 2 trial is recruiting patients to further evaluate the treatment for locally advanced unresectable uveal melanoma.
Tebentafusp-Tebn is being studied in a Phase 2 clinical trial with the identifier NCT06414590, titled 'Neoadjuvant Tebentafusp for Uveal Melanoma.' This single-arm, uncontrolled trial is recruiting 19 participants in the United States, with an age minimum of 18 years, and is not blinded or randomized.
Tebentafusp-Tebn is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials for locally advanced unresectable uveal melanoma. The drug is still in clinical development, and its safety and efficacy have not been established for regulatory approval.