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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05549297
Recruitment Status : Not yet recruiting
First Posted : September 22, 2022
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Brief 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

Condition or disease Intervention/treatment Phase
Advanced Melanoma Drug: Tebentafusp Drug: Tebentafusp with Pembrolizumab Drug: Investigators Choice Phase 2 Phase 3

Detailed Description:
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.

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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)
Estimated Study Start Date : November 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




Primary Outcome Measures :
  1. Phase 2 Primary [ Time Frame: from randomization to approximately 9 weeks ]
    ctDNA reduction on treatment relative to baseline

  2. Phase 2 Primary [ Time Frame: from randomization to approximately 2 years ]
    Overall Survival


Secondary Outcome Measures :
  1. 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

  2. Safety: Tolerability [ Time Frame: from first dose to approximately 2 years ]
    Dose Interruptions and discontinuations

  3. Safety: Tolerability [ Time Frame: from first dose to approximately 2 years ]
    Dose Reductions

  4. Serum Pharmacokinetics [ Time Frame: from first dose to approximately 2 years ]
    Tebentafusp concentration. Tmax: The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)

  5. Phase 2 Secondary [ Time Frame: from first dose to approximately 2 years ]
    Incidence of anti-tebentafusp antibodies

  6. Efficacy: Disease Control Rate [ Time Frame: from first dose to approximately 3 weeks ]
    Incidence of Grade ≥ 2 Cytokine Release Syndrome based on ASTCT grade

  7. Efficacy: Disease Control Rate [ Time Frame: from first dose to approximately 3 weeks ]
    time to onset of CRS component event

  8. Efficacy: Disease Control Rate [ Time Frame: from first dose to approximately 3 weeks ]
    duration of defined CRS component events

  9. Efficacy: Disease Control Rate [ Time Frame: from first dose to approximately 3 weeks ]
    incidence of prolonged hospitalization during the first 3 weeks of dosing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Howard Goodall +447458128573 clinicaltrials@immunocore.com
Contact: Shaad Abdullah 484-534-5261 clinicaltrials@immunocore.com

Sponsors and Collaborators
Immunocore Ltd
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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: September 22, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immunocore Ltd:
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
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents