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Tebentafusp

Phase 1b/2 Study of the Combination of IMCgp100 With Durvalumab and/or Tremelimumab in Advanced Cutaneous Melanoma

Ensayo de Immunocore Holdings plc en Melanoma maligno.

Más ensayos de: Melanoma maligno.

Fase

Fase 1/2

Estado

Retirado antes de empezar

Centros

4

Fin del objetivo primario

jun 2023

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en nov 2015.

Qué mide

Phase 2: Objective Response Rate (ORR) (Up to ~2 years) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis study was a mixed phase Ib/II, multi-center, open-label study of tebentafusp (IMCgp100) as a single agent, and in combination with durvalumab and/or tremelimumab, in metastatic cutaneous melanoma. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and to evaluate the anti-tumor activity of tebentafusp (IMCgp100) in combination with durvalumab (MEDI4736, programmed death-ligand 1 \[PD-L1\] inhibitor), tremelimumab (CLTA-4 inhibitor), and the combination of durvalumab with tremelimumab compared to single-agent tebentafusp (IMCgp100) alone administered as an intravenous or subcutaneous. The study will enroll patients who have metastatic melanoma that is refractory to treatment with an anti-PD-1 inhibitor in the metastatic setting. This study will also evaluate the safety, tolerability, and anti-tumor activity of tebentafusp (IMCgp100) monotherapy in patients with advanced non-uveal melanoma who progressed on prior PD-1 inhibitors approved for the treatment of advanced melanoma; patients with BRAF mutations must be refractory to approved BRAF-based therapy.

Más ensayos de IMCR

Todos los de IMCR, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02535078), actualizada en jul 2024.