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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
Sponsor:
Information provided by (Responsible Party):
Immunocore Ltd

Tracking Information
First Submitted Date  ICMJE August 26, 2022
First Posted Date  ICMJE September 22, 2022
Last Update Posted Date March 7, 2024
Actual Study Start Date  ICMJE December 19, 2022
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2022)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2023)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2022)
  • 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
  • Safety: Tolerability [ Time Frame: from first dose to approximately 2 years ]
    Dose Reductions
  • 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)
  • Phase 2 Secondary [ Time Frame: from first dose to approximately 2 years ]
    Incidence of anti-tebentafusp antibodies
  • Efficacy: Disease Control Rate [ Time Frame: from first dose to approximately 3 weeks ]
    Incidence of Grade ≥ 2 Cytokine Release Syndrome based on ASTCT grade
  • Efficacy: Disease Control Rate [ Time Frame: from first dose to approximately 3 weeks ]
    time to onset of CRS component event
  • Efficacy: Disease Control Rate [ Time Frame: from first dose to approximately 3 weeks ]
    duration of defined CRS component events
  • Efficacy: Disease Control Rate [ Time Frame: from first dose to approximately 3 weeks ]
    incidence of prolonged hospitalization during the first 3 weeks of dosing
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
Official Title  ICMJE 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)
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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Melanoma
Intervention  ICMJE
  • Drug: Tebentafusp
    soluble gp100-specific T cell receptor with anti-CD3 scFV
  • Drug: Tebentafusp with Pembrolizumab
    soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with Pembrolizumab
  • Drug: Investigators Choice
    Investigators choice of therapy
Study Arms  ICMJE
  • Experimental: Arm A
    Tebentafusp as single agent
    Intervention: Drug: Tebentafusp
  • Experimental: Arm B
    Tebentafusp in combination with Pembrolizumab
    Intervention: Drug: Tebentafusp with Pembrolizumab
  • Experimental: Arm C
    Straight to on protocol survival follow up including investigators choice of therapy
    Intervention: Drug: Investigators Choice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 19, 2022)		 460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2027
Estimated Primary Completion Date December 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Immunocore Medical Information 844-466-8661 medical.information@immunocore.com
Contact: Immunocore Medical Information EU +00 800-744-51111 medinfo.eu@immunocore.com
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   France,   Germany,   Italy,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05549297
Other Study ID Numbers  ICMJE IMCgp100-203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Immunocore Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Immunocore Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Immunocore Ltd
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP