Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
The purpose of this study is to evaluate the efficacy and safety of tebentafusp-based regimens, including 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.
Study details:
This is a phase 3 (as upon conversion to phase 3 there were no changes to the arms listed herein), 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 an approved anti-CTLA4 regimen and, if the participant has a BRAF mutation, a prior BRAF tyrosine kinase inhibitor (TKI) regimen.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
- Must agree to provide protocol specified samples for biomarker analyses.
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 cardiac or pulmonary disease or impaired cardiac function
- known psychiatric or substance abuse disorders
- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication or who have not completed adequate washout from prior medications.
- 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 study intervention
- ongoing Common Terminology Criteria for Adverse Events(CTCAE) Grade ≥ 2 clinically significant who in the opinion of the investigator could affect the outcome of the study
- 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 treatment with an approved anti-CTLA-4 mAb
- 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 such as hepatitis B virus (HBV) or hepatitis C virus (HCV)
- known clinically significant pulmonary or cardiac disease or impaired lung or cardiac function
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT05549297
Intervention or treatment
DRUG: Tebentafusp
DRUG: Tebentafusp with Pembrolizumab
DRUG: Investigators Choice
Conditions
- Advanced Melanoma
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Research sites nearby
Closest Location:
Melanoma Institute Australia
Select from list below to view details:
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia
Gallipoli Medical Research Foundation (GMRF)
Greenslopes, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Alfred Health
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Immunocore Ltd
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Arm A: Tebentafusp Monotherapy
| Drug: Tebentafusp |
EXPERIMENTAL: Arm B: Tebentafusp + Pembrolizumab
| Drug: Tebentafusp with Pembrolizumab |
EXPERIMENTAL: Arm C: Investigator's Choice
| Drug: Investigators Choice |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is the time from randomization to death due to any cause. | Up to ~4 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Circulating Tumor DNS (ctDNA) | Change from baseline in ctDNA will be assessed. | Up to ~9 weeks |
| Number of participants with ≥1 adverse event (AE) | Number of participants with AEs. | Up to ~4 years |
| Number of participants with ≥1 serious adverse event (SAEs) | Number of participants with SAEs. | Up to ~4 years |
| Number of participants with dose interruptions, reductions, and discontinuations from study therapy due to AEs | Number of participants with tolerability issues. | Up to ~4 years |
| Number of participants with Grade ≥2 cytokine release syndrome (CRS) | CRS based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria. | Up to ~4 years |
| Responses to the EORTC Core Quality of Life (EORTC-QLQ-C30) | Participant-reported quality of life. | At designated time points up to ~4 years |
| Responses to the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) | Participant-reported quality of life. | At designated time points up to ~4 years |
| Plasma Concentration of Tebentafusp | Plasma concentration of tebentafusp. | At designated time points up to ~4 years |
| Number of participants with anti-tebentafusp antibodies | The number of participants with anti drug antibodies (ADA) to tebentafusp. | At designated time points up to ~4 years |
References
Clinical Trials Gov: Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)Other trials to consider
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