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

Primary Purpose

Advanced Melanoma

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tebentafusp
Tebentafusp with Pembrolizumab
Investigators Choice
Sponsored by
Immunocore Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Melanoma focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orlando Health Cancer InstituteRecruiting
  • Massachusetts General HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • OU Health Stephenson Cancer CenterRecruiting
  • Thomas Jefferson University Medical Oncology ClinicRecruiting
  • UPMC Hillman Cancer CenterRecruiting
  • University of Tennessee Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Tebentafusp as single agent

Tebentafusp in combination with Pembrolizumab

Straight to on protocol survival follow up including investigators choice of therapy

Outcomes

Primary Outcome Measures

Phase 2 Primary
ctDNA reduction on treatment relative to baseline
Phase 2 Primary
Overall Survival

Secondary Outcome Measures

Safety: Adverse Events and Severe Adverse Events
Incidence and severity of AEs, SAEs and changes from baseline in laboratory parameters, vital signs, and ECGs
Safety: Tolerability
Dose Interruptions and discontinuations; Dose Reductions
Serum Pharmacokinetics
Tebentafusp concentration. Tebentafusp PK parameters (eg, Cmax, Tmax, Cavg, t1/2)
Phase 2 Secondary
Incidence of anti-tebentafusp antibodies

Full Information

First Posted
August 26, 2022
Last Updated
September 26, 2023
Sponsor
Immunocore Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05549297
Brief Title
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunocore Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Melanoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Tebentafusp as single agent
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Tebentafusp in combination with Pembrolizumab
Arm Title
Arm C
Arm Type
Experimental
Arm Description
Straight to on protocol survival follow up including investigators choice of therapy
Intervention Type
Drug
Intervention Name(s)
Tebentafusp
Intervention Description
soluble gp100-specific T cell receptor with anti-CD3 scFV
Intervention Type
Drug
Intervention Name(s)
Tebentafusp with Pembrolizumab
Intervention Description
soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with Pembrolizumab
Intervention Type
Drug
Intervention Name(s)
Investigators Choice
Intervention Description
Investigators choice of therapy
Primary Outcome Measure Information:
Title
Phase 2 Primary
Description
ctDNA reduction on treatment relative to baseline
Time Frame
from randomization to approximately 9 weeks
Title
Phase 2 Primary
Description
Overall Survival
Time Frame
from randomization to approximately 2 years
Secondary Outcome Measure Information:
Title
Safety: Adverse Events and Severe Adverse Events
Description
Incidence and severity of AEs, SAEs and changes from baseline in laboratory parameters, vital signs, and ECGs
Time Frame
from first dose to approximately 2 years
Title
Safety: Tolerability
Description
Dose Interruptions and discontinuations; Dose Reductions
Time Frame
from first dose to approximately 2 years
Title
Serum Pharmacokinetics
Description
Tebentafusp concentration. Tebentafusp PK parameters (eg, Cmax, Tmax, Cavg, t1/2)
Time Frame
from first dose to approximately 2 years
Title
Phase 2 Secondary
Description
Incidence of anti-tebentafusp antibodies
Time Frame
from first dose to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Lead
Phone
+00 800-74451111
Email
clinicaltrials@immunocore.com
Facility Information:
Facility Name
Orlando Health Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
OU Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University Medical Oncology Clinic
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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