Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
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ClinicalTrials.gov Identifier: NCT05549297 |
Recruitment Status :
Recruiting
First Posted : September 22, 2022
Last Update Posted : March 7, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Melanoma | Drug: Tebentafusp Drug: Tebentafusp with Pembrolizumab Drug: Investigators Choice | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 460 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | December 19, 2022 |
Estimated Primary Completion Date : | December 2026 |
Estimated Study Completion Date : | September 2027 |
Arm | Intervention/treatment |
---|---|
Experimental: Arm A
Tebentafusp as single agent
|
Drug: Tebentafusp
soluble gp100-specific T cell receptor with anti-CD3 scFV |
Experimental: Arm B
Tebentafusp in combination with Pembrolizumab
|
Drug: Tebentafusp with Pembrolizumab
soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with Pembrolizumab |
Experimental: Arm C
Straight to on protocol survival follow up including investigators choice of therapy
|
Drug: Investigators Choice
Investigators choice of therapy |
- Phase 2 Primary [ Time Frame: from randomization to approximately 9 weeks ]ctDNA reduction on treatment relative to baseline
- Phase 2 Primary [ Time Frame: from randomization to approximately 2 years ]Overall Survival
- Safety: Adverse Events and Severe Adverse Events [ Time Frame: from first dose to approximately 2 years ]Incidence and severity of AEs, SAEs and changes from baseline in laboratory parameters, vital signs, and ECGs
- Safety: Tolerability [ Time Frame: from first dose to approximately 2 years ]Dose Interruptions and discontinuations; Dose Reductions
- Serum Pharmacokinetics [ Time Frame: from first dose to approximately 2 years ]Tebentafusp concentration. Tebentafusp PK parameters (eg, Cmax, Tmax, Cavg, t1/2)
- Phase 2 Secondary [ Time Frame: from first dose to approximately 2 years ]Incidence of anti-tebentafusp antibodies
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 with clinically significant cardiac 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 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 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 such as hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05549297
Contact: Immunocore Medical Information | 844-466-8661 | medical.information@immunocore.com | |
Contact: Immunocore Medical Information EU | +00 800-744-51111 | medinfo.eu@immunocore.com |
Responsible Party: | Immunocore Ltd |
ClinicalTrials.gov Identifier: | NCT05549297 |
Other Study ID Numbers: |
IMCgp100-203 |
First Posted: | September 22, 2022 Key Record Dates |
Last Update Posted: | March 7, 2024 |
Last Verified: | March 2024 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Melanoma IMCgp100 Tebentafusp Cutaneous Melanoma Immunotherapy gp100 TCR Pembrolizumab Bispecific T cell receptor fusion protein |
ImmTAC (Immune-mobilizing monoclonal T-cell receptor Against Cancer) Immune mobilizing monoclonal T cell receptor against cancer KIMMTRAK Acral Melanoma Mucosal Melanoma Blue Nevus anti-PDL1 checkpoint therapy |
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas |
Skin Neoplasms Neoplasms by Site Skin Diseases Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |