Montag, 29. April 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE
eVOLVE-HNSCC

A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy

Rekrutierend

NCT-Nummer:
NCT06129864

Studienbeginn:
Dezember 2023

Letztes Update:
08.04.2024

Wirkstoff:
Volrustomig

Indikation (Clinical Trials):
Carcinoma, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Studienleiter

Robert Haddad, MD
Study Chair
Dana Farber Cancer Institute Massachusetts, USA
Lisa Licitra, MD
Study Chair
Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan Milan, Italy

Kontakt

AstraZeneca Clinical Study Information Center
Kontakt:
Phone: 1-877-240-9479
E-Mail: information.center@astrazeneca.com» Kontaktdaten anzeigen

Studienlocations
(3 von 196)

Research Site
45122 Essen
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
17475 Greifswald
(Mecklenburg-Vorpommern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
20246 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
23538 Lübeck
(Schleswig-Holstein)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
81675 München
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
18059 Rostock
(Mecklenburg-Vorpommern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
72076 Tübingen
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
97070 Würzburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
Research Site
35233 Birmingham
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
86314 Prescott Valley
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
72762 Springdale
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
90024 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
92868 Orange
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
94143 San Francisco
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
80045 Aurora
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
80124 Lone Tree
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
32909 Palm Bay
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
60714 Niles
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
50309 Des Moines
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
66160 Kansas City
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
40202 Louisville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
70817 Baton Rouge
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
71101 Shreveport
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
21044 Columbia
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
20782 Hyattsville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
21204 Towson
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
02215 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
48105 Ann Arbor
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
48109 Ann Arbor
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
55417 Minneapolis
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
65211 Columbia
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
63110 Saint Louis
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
08816 East Brunswick
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
07601 Hackensack
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
08901 New Brunswick
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
87108 Albuquerque
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
10075 New York
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
11794 Stony Brook
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
28204 Charlotte
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
27157 Winston-Salem
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
44106 Cleveland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
97213 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
97239 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
19107 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
15261 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
37212 Nashville
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
78745 Austin
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
75251 Dallas
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
77030 Houston
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
79761 Odessa
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
84112 Salt Lake City
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
22031 Fairfax
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
23502 Norfolk
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
23230 Richmond
United StatesNoch nicht rekrutierend» Google-Maps
Research Site
14784-400 Barretos
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
88034-000 Florianópolis
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
60336-045 Fortaleza
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
35162-189 Ipatinga
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
86015-520 Londrina
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
91350200 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
14051-140 Ribeirão Preto
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
20231-050 Rio de Janeiro
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
01509-900 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
04538-132 Sao Paulo
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
64049-200 Teresina
BrazilNoch nicht rekrutierend» Google-Maps
Research Site
84918 Avignon Cedex 09
FranceNoch nicht rekrutierend» Google-Maps
Research Site
44805 Saint Herblain
FranceNoch nicht rekrutierend» Google-Maps
Research Site
31059 Toulouse Cedex 09
FranceNoch nicht rekrutierend» Google-Maps
Research Site
4400 Nyíregyháza
HungaryNoch nicht rekrutierend» Google-Maps
Research Site
695011 Thiruvananthapuram
IndiaNoch nicht rekrutierend» Google-Maps
Research Site
466-8560 Nagoya-shi
JapanNoch nicht rekrutierend» Google-Maps
Research Site
700-8558 Okayama-shi
JapanNoch nicht rekrutierend» Google-Maps
Research Site
980-8574 Sendai-shi
JapanNoch nicht rekrutierend» Google-Maps
Research Site
410-769 Goyang-si
Korea, Republic ofRekrutierend» Google-Maps
Research Site
13620 Gyeonggi-do
Korea, Republic ofRekrutierend» Google-Maps
Research Site
10450 George Town
MalaysiaNoch nicht rekrutierend» Google-Maps
Research Site
81100 Johor Bahru
MalaysiaNoch nicht rekrutierend» Google-Maps
Research Site
50586 Kuala Lumpur
MalaysiaNoch nicht rekrutierend» Google-Maps
Research Site
59100 Kuala Lumpur
MalaysiaNoch nicht rekrutierend» Google-Maps
Research Site
AB25 2ZN Aberdeen
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
SO16 6YD Hampshire
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
LS9 7TF Leeds
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
SE1 9RT London
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
SW3 6JJ London
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
M20 4BX Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
HA6 2RN Northwood
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
SM2 5PT Sutton
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
TA1 5DA Taunton
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
CH63 4JY Wirral
United KingdomNoch nicht rekrutierend» Google-Maps
Research Site
700000 Ho Chi Minh City
VietnamNoch nicht rekrutierend» Google-Maps
Research Site
700000 Ho Chi Minh
VietnamNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The main purpose of this study is to assess the efficacy and safety of volrustomig compared

to observation in participants with unresected locally advanced head and neck squamous cell

carcinoma (LA-HNSCC) who have not progressed after receiving definitive concurrent

chemoradiotherapy (cCRT).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically documented locally advanced squamous cell carcinoma of

the oropharynx, hypopharynx, oral cavity, or larynx with no evidence of metastatic

disease (i.e. M0).

- Confirmed unresected Stage III, Stage IVA or IVB according to the eighth edition of

the American Joint Committee on Cancer (AJCC) staging manual (tumor, node, metastasis

(TNM) staging system).

- Participants will have completed definitive concurrent chemoradiotherapy (cCRT) with

curative intent within 12 weeks prior to randomization.

Exclusion Criteria:

- Histologically/cytologically confirmed head and neck cancer of any other primary

anatomic location in the head and neck not specified in the inclusion criteria

including participants with squamous cell carcinoma of unknown primary or non-squamous

histologies (eg, nasopharynx or salivary gland). Participants with >1 primary tumors

are not eligible for the study.

- Participants with any of the following:

1. Residual disease that needs further treatment with curative intent after

definitive cCRT administration;

2. LA-HNSCC that was resected before definitive cCRT

3. LA-HNSCC that was treated and is recurrent at the time of screening

- Participants who have received radiotherapy (RT) alone as definitive local therapy for

LA-HNSCC.

- Receipt of the last dose of anticancer therapy (chemotherapy and/or RT) > 12 weeks (84

days) prior to randomization.

Studien-Rationale

Primary outcome:

1. Progression-Free Survival (PFS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors (Time Frame - Up to approximately 7 years):
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by Blinded Independent Central Review (BICR), or death due to any cause (in the absence of progression). The analysis will include all randomized participants with PD-L1 expressing tumors.



Secondary outcome:

1. Progression-Free Survival (PFS) in the unresected LA-HNSCC intent-to-treat (ITT) population (Time Frame - Up to approximately 7 years):
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.

2. Landmark Progression-Free Survival (PFS) Rates (Time Frame - Up to approximately 7 years):
PFS is defined as time from randomization until first objective radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). These analyses will include participants with PD-L1 expressing tumors and all randomized participants.

3. Overall Survival (OS) in participants with unresected LA-HNSCC with PD-L1 expressing tumors (Time Frame - Up to approximately 7 years):
Overall survival (OS) is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants with PD-L1 expressing tumors.

4. Landmark Overall Survival (OS) Rates (Time Frame - Up to approximately 7 years):
OS is defined as the time from randomization until the date of death due to any cause. These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants.

5. Overall Survival (OS) in the unresected LA-HNSCC ITT population (Time Frame - Up to approximately 7 years):
OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.

6. Progression Free Survival 2 (PFS2) (Time Frame - Up to approximately 7 years):
PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice. These analyses will include participants with PD-L1 expressing tumors as randomized and all randomized participants.

7. Presence of Anti-Drug-Antibodies (ADAs) against volrustomig in serum (Time Frame - Up to approximately 7 years):
To investigate the immunogenicity of volrustomig.

8. Participant-reported physical functioning (Time Frame - Up to approximately 7 years):
Change from baseline of physical functioning as measured by scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form v.20 - Physical Function 8c are reported on a T score metric (mean = 50 and SD = 10), with higher scores reflecting better physical functioning. The analysis will include all randomized participants.

9. Participant-reported global health status (GHS)/quality of life (QoL) (Time Frame - Up to approximately 7 years):
Change from baseline of Global Health Status/Quality of Life subscale scores as measured by the European Organization for Research and Treatment of Cancer (EORTC) Item Library 172 are transformed to a 0-100 range; a higher score represents higher quality of life. The analysis will include all randomized participants.

10. Percentage of participants with Adverse Events (Time Frame - Up to approximately 7 years):
Adverse Events as assessed by Common Terminology Criteria for Adverse Events (CTCAE).

11. Area under the curve (AUC) (Time Frame - Up to approximately 7 years):
The concentration of MEDI5752 in serum will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered.

12. Maximum plasma concentration of the drug (Cmax) (Time Frame - Up to approximately 7 years):
The concentration of MEDI5752 in serum will be determined (Cmax will be derived).

13. The time taken to reach the maximum concentration (Tmax) (Time Frame - Up to approximately 7 years):
The concentration of MEDI5752 in serum will be determined (Tmax will be derived).

Studien-Arme

  • Experimental: Study Arm
    Participants in this arm will receive volrustomig.
  • No Intervention: Observation Arm
    Patients in this arm will undergo observation.

Geprüfte Regime

  • volrustomig (MEDI5752):
    volrustomig

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"A Global Study of Volrustomig (MEDI5752) for Participants With Unresected Locally Advanced Head and Neck Squamous Cell Carcinoma Following Definitive Concurrent Chemoradiotherapy"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!

Die Verwendung Ihrer Daten für den Newsletter können Sie jederzeit mit Wirkung für die Zukunft gegenüber der MedtriX GmbH - Geschäftsbereich rs media widersprechen ohne dass Kosten entstehen. Nutzen Sie hierfür etwaige Abmeldelinks im Newsletter oder schreiben Sie eine E-Mail an: rgb-info[at]medtrix.group.