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

• Status: Not yet recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immunocore Ltd
• Treatments: Pembrolizumab

Criteria

Inclusion Criteria:

• HLA-A*02:01-positive.

• unresectable Stage III or Stage IV non-ocular melanoma

• archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.

• measurable or non-measurable disease per RECIST 1.1

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

• If applicable, must agree to use highly effective contraception

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol

Exclusion Criteria:

• Pregnant or lactating women

• diagnosis of ocular or metastatic uveal melanoma

• history of a malignant disease other than those being treated in this study

• ineligible to be retreated with pembrolizumab due to a treatment-related AE

• known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis

• previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)

• active autoimmune disease requiring immunosuppressive treatment

• clinically significant medical condition

• known psychiatric or substance abuse disorders

• received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication

• received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose

• received cellular therapies within 90 days of first dose

• received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose

• have not progressed on treatment with an anti-PD(L)1 mAb

• have not received prior ipilimumab

• a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen

• currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose

• known history of chronic viral infections

• Out of range Laboratory values

• history of allogenic tissue/solid organ transplant