Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Nevus, Pigmented

Nevus

Nevus, Blue

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Acral Lentiginous Melanoma

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Pembrolizumab

Atezolizumab

Immunomodulating Agents

Muromonab-CD3

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Tebentafusp in combination with Pembrolizumab

Straight to on protocol survival follow up including investigators choice of therapy

soluble gp100-specific T cell receptor with anti-CD3 scFV

Tebentafusp

soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with Pembrolizumab

Tebentafusp with Pembrolizumab

Investigators Choice

Immunocore Medical Information

Immunocore Medical Information EU

To evaluate the efficacy and safety of tebentafusp-based regimens tebentafusp monotherapy and in combination with anti-PD1 vs investigator choice (including clinical trials of investigational agents, salvage therapy per local standard of care (SoC), best supportive care (BSC)) on protocol survivor follow up) in patients with advanced non-ocular melanoma

This is a Phase 2/3, multicenter, open-label study to evaluate the efficacy and safety of tebentafusp as monotherapy (Arm A) and in combination with pembrolizumab (Arm B) compared with standard of care or best supportive care (Arm C) in participants with non-ocular advanced melanoma who have progressed on a prior anti-PD(L)1 regimen, received prior ipilimumab and, if the participant has a BRAF mutation, a prior BRAF tyrosine kinase inhibitor (TKI) regimen.

Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)

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

ctDNA reduction on treatment relative to baseline

Incidence and severity of AEs, SAEs and changes from baseline in laboratory parameters, vital signs, and ECGs

Dose Interruptions and discontinuations; Dose Reductions

Tebentafusp concentration. Tebentafusp PK parameters (eg, Cmax, Tmax, Cavg, t1/2)

Spots Global Cancer Trial Database for investigators choice