Trial Title:
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
NCT ID:
NCT05549297
Condition:
Advanced Melanoma
Conditions: Official terms:
Melanoma
Pembrolizumab
Conditions: 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
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tebentafusp
Description:
soluble gp100-specific T cell receptor with anti-CD3 scFV
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Tebentafusp with Pembrolizumab
Description:
soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with
Pembrolizumab
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Investigators Choice
Description:
Investigators choice of therapy
Arm group label:
Arm C
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic Arizona
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Facility:
Name:
Orlando Health Cancer Institute
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Facility:
Name:
Winship Cancer Institute of Emory University
Address:
City:
Atlanta
Zip:
30322
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Minnesota Medical Center - Masonic Cancer Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Mayo Clinic Minnesota
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Facility:
Name:
Rutgers Cancer Institute of New Jersey
Address:
City:
New Brunswick
Zip:
08901
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwell Health Cancer Institute - Zuckerberg Cancer Center
Address:
City:
Lake Success
Zip:
11042
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Facility:
Name:
OU Health Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Facility:
Name:
Thomas Jefferson University Medical Oncology Clinic
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Facility:
Name:
UPMC Hillman Cancer Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Facility:
Name:
Gibbs Cancer Center and Research Institute
Address:
City:
Spartanburg
Zip:
29303
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Tennessee Medical Center
Address:
City:
Knoxville
Zip:
37920
Country:
United States
Status:
Recruiting
Facility:
Name:
Houston Methodist Hospital/Houston Methodist Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Utah - Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Melanoma Institute Australia
Address:
City:
Wollstonecraft
Zip:
2065
Country:
Australia
Status:
Recruiting
Facility:
Name:
Gallipoli Medical Research Foundation (GMRF)
Address:
City:
Greenslopes
Zip:
4120
Country:
Australia
Status:
Recruiting
Facility:
Name:
Princess Alexandra Hospital
Address:
City:
Woolloongabba
Zip:
4102
Country:
Australia
Status:
Recruiting
Facility:
Name:
Alfred Health
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
LKH - Universitaetsklinikum Graz
Address:
City:
Graz
Zip:
8036
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Kepler Universitätsklinikum
Address:
City:
Linz
Zip:
4020
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Universitatsklinik fur Innere Medizin 3
Address:
City:
Salzburg
Zip:
5020
Country:
Austria
Status:
Recruiting
Facility:
Name:
AKH - Medizinische Universität Wien
Address:
City:
Wien
Zip:
1090
Country:
Austria
Status:
Not yet recruiting
Facility:
Name:
Cliniques Universitaires Sain-Luc
Address:
City:
Bruxelles
Zip:
1200
Country:
Belgium
Status:
Recruiting
Facility:
Name:
UZ Brussel
Address:
City:
Jette
Zip:
1090
Country:
Belgium
Status:
Recruiting
Facility:
Name:
UZ Leuven
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Not yet recruiting
Facility:
Name:
Centre Leon Berard
Address:
City:
Lyon
Zip:
69373
Country:
France
Status:
Recruiting
Facility:
Name:
Institute Claudius Regaud
Address:
City:
Toulouse
Zip:
31059
Country:
France
Status:
Recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Villejuif
Zip:
94805
Country:
France
Status:
Recruiting
Facility:
Name:
CHU de Bordeaux - Hopital Saint Andre
Address:
City:
Bordeaux
Zip:
22075
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital de la Timone [Recruiting]
Address:
City:
Marseille
Zip:
13005
Country:
France
Status:
Recruiting
Facility:
Name:
Hopital Saint Lous - APHP
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Schleswig-Holstein
Address:
City:
Schleswig
Zip:
24105
Country:
Germany
Status:
Recruiting
Facility:
Name:
Klinische Studien Hauttumorcentrum
Address:
City:
Berlin
Zip:
10115
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitatsklinikum Carl Gustav Carus Dresden
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Facility:
Name:
Onkologische Studienxentrale Houtklinik Erlangen
Address:
City:
Erlangen
Zip:
91054
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Essen
Address:
City:
Essen
Zip:
45147
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitaetsklinikum Hamburg-Eppendorf
Address:
City:
Hamburg
Zip:
20246
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Heidelberg
Address:
City:
Heidelberg
Zip:
69120
Country:
Germany
Status:
Recruiting
Facility:
Name:
Universitaetsklinikum Schleswig-Holstein
Address:
City:
Kiel
Zip:
24105
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Johannes Wesling Klinikum Minden
Address:
City:
Minden
Zip:
32429
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
LMU-Campus Innenstadt
Address:
City:
Munich
Zip:
80336
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Universitaetsklinikum Tübingen
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Not yet recruiting
Facility:
Name:
Fondazione IRCCS Istituto Nazionale dei Tumori
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Instituto Nazionale Tumori Fondazione G. Pascale
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Italy, Perugia Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
Address:
City:
Perugia
Zip:
06129
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
A.O.U Senese Policlinico Santa Maria alle Scotte
Address:
City:
Siena
Zip:
53100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
Address:
City:
Bydgoszcz
Zip:
85-796
Country:
Poland
Status:
Recruiting
Facility:
Name:
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
Address:
City:
Gdańsk
Zip:
80214
Country:
Poland
Status:
Recruiting
Facility:
Name:
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
Address:
City:
Poznań
Zip:
60355
Country:
Poland
Status:
Not yet recruiting
Facility:
Name:
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Address:
City:
Warsaw
Zip:
02781
Country:
Poland
Status:
Recruiting
Facility:
Name:
Hospital Universitari Vall d'Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Clinico de Barcelona
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital General Universitario Gregorio Marañon
Address:
City:
Madrid
Zip:
28007
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital Universitario Ramon y Cajal
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Regional Universitario de Malaga
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Hospital General Universitario de Valencia
Address:
City:
Valencia
Zip:
46014
Country:
Spain
Status:
Not yet recruiting
Facility:
Name:
Kantonsspital St. Gallen
Address:
City:
Saint Gallen
Zip:
9000
Country:
Switzerland
Status:
Not yet recruiting
Facility:
Name:
Universitaetsspital Zurich
Address:
City:
Zürich
Zip:
8058
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Addenbrooke's Hospital
Address:
City:
Cambridge
Zip:
CB2 0QQ
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Guy's & St Thomas' NHS Foundation Trust
Address:
City:
Lambeth
Zip:
SE1 7EH
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Queen Elizabeth Hospital
Address:
City:
Birmingham
Zip:
B15 2TH
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Leeds General Infirmary
Address:
City:
Leeds
Zip:
LS1 3EX
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Barts Hospital
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Royal Marsden Hospital - Chelsea
Address:
City:
London
Zip:
SW3 6JJ
Country:
United Kingdom
Status:
Not yet recruiting
Facility:
Name:
Mount Vernon Cancer Center
Address:
City:
Middlesex
Zip:
HA6 2RN
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Royal Marsden Hospital - Sutton
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Status:
Not yet recruiting
Start date:
December 19, 2022
Completion date:
September 2027
Lead sponsor:
Agency:
Immunocore Ltd
Agency class:
Industry
Source:
Immunocore Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05549297
