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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05549297

Studienbeginn:
Dezember 2022

Letztes Update:
07.03.2024

Wirkstoff:
Tebentafusp, Tebentafusp with Pembrolizumab, Investigators Choice

Indikation (Clinical Trials):
Melanoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Immunocore Ltd

Collaborator:
-

Kontakt

Immunocore Medical Information
Kontakt:
Phone: 844-466-8661
E-Mail: medical.information@immunocore.com» Kontaktdaten anzeigen
Immunocore Medical Information EU
Kontakt:
Phone: +00 800-744-51111
E-Mail: medinfo.eu@immunocore.com» Kontaktdaten anzeigen

Studienlocations
(3 von 71)

Universitaetsklinikum Schleswig-Holstein
24105 Schleswig
(Schleswig-Holstein)
GermanyRekrutierend» Google-Maps
Klinische Studien Hauttumorcentrum
10115 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Universitatsklinikum Carl Gustav Carus Dresden
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Onkologische Studienxentrale Houtklinik Erlangen
91054 Erlangen
(Bayern)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Essen
45147 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Hamburg-Eppendorf
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Heidelberg
69120 Heidelberg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Schleswig-Holstein
24105 Kiel
(Schleswig-Holstein)
GermanyNoch nicht rekrutierend» Google-Maps
Johannes Wesling Klinikum Minden
32429 Minden
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
LMU-Campus Innenstadt
80336 Munich
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Tübingen
72076 Tübingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Mayo Clinic Florida
32224 Jacksonville
United StatesRekrutierend» Google-Maps
Orlando Health Cancer Institute
32806 Orlando
United StatesRekrutierend» Google-Maps
Winship Cancer Institute of Emory University
30322 Atlanta
United StatesNoch nicht rekrutierend» Google-Maps
Massachusetts General Hospital
02114 Boston
United StatesRekrutierend» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
University of Minnesota Medical Center - Masonic Cancer Center
55455 Minneapolis
United StatesNoch nicht rekrutierend» Google-Maps
Mayo Clinic Minnesota
55905 Rochester
United StatesRekrutierend» Google-Maps
Rutgers Cancer Institute of New Jersey
08901 New Brunswick
United StatesRekrutierend» Google-Maps
Northwell Health Cancer Institute - Zuckerberg Cancer Center
11042 Lake Success
United StatesNoch nicht rekrutierend» Google-Maps
Memorial Sloan Kettering Cancer Center
10065 New York
United StatesRekrutierend» Google-Maps
OU Health Stephenson Cancer Center
73104 Oklahoma City
United StatesRekrutierend» Google-Maps
Thomas Jefferson University Medical Oncology Clinic
19107 Philadelphia
United StatesRekrutierend» Google-Maps
UPMC Hillman Cancer Center
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
Gibbs Cancer Center and Research Institute
29303 Spartanburg
United StatesNoch nicht rekrutierend» Google-Maps
University of Tennessee Medical Center
37920 Knoxville
United StatesRekrutierend» Google-Maps
Houston Methodist Hospital/Houston Methodist Cancer Center
77030 Houston
United StatesRekrutierend» Google-Maps
University of Utah - Huntsman Cancer Institute
84112 Salt Lake City
United StatesNoch nicht rekrutierend» Google-Maps
Melanoma Institute Australia
2065 Wollstonecraft
AustraliaRekrutierend» Google-Maps
Gallipoli Medical Research Foundation (GMRF)
4120 Greenslopes
AustraliaRekrutierend» Google-Maps
Princess Alexandra Hospital
4102 Woolloongabba
AustraliaRekrutierend» Google-Maps
LKH - Universitaetsklinikum Graz
8036 Graz
AustriaNoch nicht rekrutierend» Google-Maps
Kepler Universitätsklinikum
4020 Linz
AustriaNoch nicht rekrutierend» Google-Maps
Universitatsklinik fur Innere Medizin 3
5020 Salzburg
AustriaRekrutierend» Google-Maps
AKH - Medizinische Universität Wien
1090 Wien
AustriaNoch nicht rekrutierend» Google-Maps
Cliniques Universitaires Sain-Luc
1200 Bruxelles
BelgiumRekrutierend» Google-Maps
CHU de Bordeaux - Hopital Saint Andre
22075 Bordeaux
FranceRekrutierend» Google-Maps
Hopital de la Timone [Recruiting]
13005 Marseille
FranceRekrutierend» Google-Maps
Fondazione IRCCS Istituto Nazionale dei Tumori
20133 Milano
ItalyRekrutierend» Google-Maps
Instituto Nazionale Tumori Fondazione G. Pascale
80131 Napoli
ItalyRekrutierend» Google-Maps
Italy, Perugia Azienda Ospedaliera di Perugia Ospedale S. Maria della Misericordia
06129 Perugia
ItalyNoch nicht rekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
00168 Roma
ItalyRekrutierend» Google-Maps
A.O.U Senese Policlinico Santa Maria alle Scotte
53100 Siena
ItalyRekrutierend» Google-Maps
Centrum Onkologii im. prof. F. Lukaszczyka w Bydgoszczy
85-796 Bydgoszcz
PolandRekrutierend» Google-Maps
Uniwersyteckie Centrum Kliniczne (UCK) - Klinika Onkologii i Radioterapii
80214 Gdańsk
PolandRekrutierend» Google-Maps
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu
60355 Poznań
PolandNoch nicht rekrutierend» Google-Maps
Narodowy Instytut Onkologii-im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
02781 Warsaw
PolandRekrutierend» Google-Maps
Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainNoch nicht rekrutierend» Google-Maps
Hospital Clinico de Barcelona
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Marañon
28007 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal
28034 Madrid
SpainRekrutierend» Google-Maps
Hospital Regional Universitario de Malaga
29010 Málaga
SpainNoch nicht rekrutierend» Google-Maps
Hospital General Universitario de Valencia
46014 Valencia
SpainNoch nicht rekrutierend» Google-Maps
Kantonsspital St. Gallen
9000 Saint Gallen
SwitzerlandNoch nicht rekrutierend» Google-Maps
Universitaetsspital Zurich
8058 Zürich
SwitzerlandRekrutierend» Google-Maps
Addenbrooke's Hospital
CB2 0QQ Cambridge
United KingdomRekrutierend» Google-Maps
Guy's & St Thomas' NHS Foundation Trust
SE1 7EH Lambeth
United KingdomNoch nicht rekrutierend» Google-Maps
Queen Elizabeth Hospital
B15 2TH Birmingham
United KingdomRekrutierend» Google-Maps
Leeds General Infirmary
LS1 3EX Leeds
United KingdomNoch nicht rekrutierend» Google-Maps
Barts Hospital
EC1A 7BE London
United KingdomNoch nicht rekrutierend» Google-Maps
Royal Marsden Hospital - Chelsea
SW3 6JJ London
United KingdomNoch nicht rekrutierend» Google-Maps
Mount Vernon Cancer Center
HA6 2RN Middlesex
United KingdomRekrutierend» Google-Maps
Royal Marsden Hospital - Sutton
SM2 5PT Sutton
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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:

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; Dose Reductions

3. Serum Pharmacokinetics (Time Frame - from first dose to approximately 2 years):
Tebentafusp concentration. Tebentafusp PK parameters (eg, Cmax, Tmax, Cavg, t1/2)

4. Phase 2 Secondary (Time Frame - from first dose to approximately 2 years):
Incidence of anti-tebentafusp antibodies

Studien-Arme

  • Experimental: Arm A
    Tebentafusp as single agent
  • Experimental: Arm B
    Tebentafusp in combination with Pembrolizumab
  • Experimental: Arm C
    Straight to on protocol survival follow up including investigators choice of therapy

Geprüfte Regime

  • Tebentafusp:
    soluble gp100-specific T cell receptor with anti-CD3 scFV
  • Tebentafusp with Pembrolizumab:
    soluble gp100-specific T cell receptor with anti-CD3 scFV in combination with Pembrolizumab
  • Investigators Choice:
    Investigators choice of therapy

Quelle: ClinicalTrials.gov


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