Donnerstag, 2. Mai 2024
Navigation öffnen
Anzeige:
Wefra Programatic
 
JOURNAL ONKOLOGIE – STUDIE

Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Rekrutierend

NCT-Nummer:
NCT05287113

Studienbeginn:
November 2022

Letztes Update:
23.02.2024

Wirkstoff:
Retifanlimab, INCAGN02385, INCAGN02390, Placebo

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Incyte Biosciences International Sàrl

Collaborator:
-

Kontakt

Incyte Corporation Call Center (ex-US)
Kontakt:
Phone: +800 00027423
E-Mail: globalmedinfo@incyte.com» Kontaktdaten anzeigen

Studienlocations
(3 von 91)

University of Cologne
50937 Cologne
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitatsklinikum Hamburg Eppendorf
20246 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Asklepios Klinik Altona
22763 Hamburg
(Hamburg)
GermanyNoch nicht rekrutierend» Google-Maps
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
55131 Mainz
(Rheinland-Pfalz)
GermanyNoch nicht rekrutierend» Google-Maps
Mayo Clinic Rochester
85259 Scottsdale
United StatesNoch nicht rekrutierend» Google-Maps
City of Hope National Medical Center
91010-9200 Duarte
United StatesNoch nicht rekrutierend» Google-Maps
City of Hope Orange County
92618 Irvine
United StatesRekrutierend» Google-Maps
University of California San Diego Medical Center, Moores Cancer Center
92093 La Jolla
United StatesNoch nicht rekrutierend» Google-Maps
City of Hope-Antelope Valley
93534 Lancaster
United StatesRekrutierend» Google-Maps
Innovative Clinical Research Institute
90805 Long Beach
United StatesRekrutierend» Google-Maps
City of Hope National Medical Center
90813 Long Beach
United StatesRekrutierend» Google-Maps
University of California San Francisco Comprehensive Cancer Center
94115 San Francisco
United StatesRekrutierend» Google-Maps
Georgetown University
20057 Washington
United StatesRekrutierend» Google-Maps
Mayo Clinic Jacksonville
32224 Jacksonville
United StatesRekrutierend» Google-Maps
Moffitt Cancer Center
33612-9416 Tampa
United StatesNoch nicht rekrutierend» Google-Maps
University of Illinois At Chicago
60612 Chicago
United StatesRekrutierend» Google-Maps
University of Iowa
52242-1316 Iowa City
United StatesRekrutierend» Google-Maps
University of Kansas Hospital Authority
66103 Kansas City
United StatesRekrutierend» Google-Maps
University of Maryland-Greenebaum Cancer Center
21201 Baltimore
United StatesRekrutierend» Google-Maps
Dana Farber Cancer Institute
02215 Boston
United StatesRekrutierend» Google-Maps
University of Michigan Cancer Center
48109 Ann Arbor
United StatesNoch nicht rekrutierend» Google-Maps
Barbara Ann Karmanos Cancer Hospital
48201 Detroit
United StatesRekrutierend» Google-Maps
Hackensack University Medical Center
07601 Hackensack
United StatesRekrutierend» Google-Maps
Fox Chase Cancer Center
19111 Philadelphia
United StatesRekrutierend» Google-Maps
Huntsman Cancer Institute At University of Utah
84112 Salt Lake City
United StatesRekrutierend» Google-Maps
University of Virginia - Emily Couric Clinical Cancer Center
22903 Charlottesville
United StatesRekrutierend» Google-Maps
Kadlec Clinic Hematology and Oncology
99336 Kennewick
United StatesRekrutierend» Google-Maps
Grand Hospital de Charleroi
06000 Charleroi
BelgiumAbgeschlossen» Google-Maps
McGill University Health Centre/Glen Site/Cedars Cancer Centre
H2X 3E4 Montreal
CanadaRekrutierend» Google-Maps
Chum Hospital Notre Dame
H2X3E4 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
McGill University Jewish General Hospital
H3T 1E2 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Centre Hospitalier Universitaire de Bordeaux
33000 Bordeaux
FranceRekrutierend» Google-Maps
Centre de Lutte Contre Le Cancer - Institut de Cancerologie de L'Ouest - Rene Gauducheau
44805 St Herblain
FranceNoch nicht rekrutierend» Google-Maps
Icans - Institut de Cancerologie Strasbourg Europe
67200 Strasbourg
FranceRekrutierend» Google-Maps
Jsc Evex Corporation-Caraps Medline
00159 Tbilisi
GeorgiaRekrutierend» Google-Maps
University Hospital of West Attica - Attikon
12462 Chaidari
GreeceRekrutierend» Google-Maps
Theagenio Anticancer Hospital
54007 Thessaloniki
GreeceRekrutierend» Google-Maps
Bioclinic Thessaloniki (Galinos Clinic)
54622 Thessaloniki
GreeceRekrutierend» Google-Maps
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo
10060 Candiolo
ItalyRekrutierend» Google-Maps
Fondazione Irccs Istituto Nazionale Del Tumori Di Milano
20133 Milan
ItalyRekrutierend» Google-Maps
Istituto Nazionale Tumori Irccs Fondazione Pascale
80131 Naples
ItalyRekrutierend» Google-Maps
Iov - Istituto Oncologico Veneto Irccs
35128 Padova
ItalyRekrutierend» Google-Maps
Fondazione Irccs Policlinico San Matteo
27100 Pavia
ItalyAbgeschlossen» Google-Maps
Ausl-Irccs Di Reggio Emilia
42123 Reggio Emilia
ItalyRekrutierend» Google-Maps
Pusan National University Yangsan Hospital
49241 Busan
Korea, Republic ofRekrutierend» Google-Maps
Chonnam National University Hwasun Hospital
58128 Gwangju
Korea, Republic ofRekrutierend» Google-Maps
Cha Bundang Medical Center
13496 Seongnam-si
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Korea University Anam Hospital
02841 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Kangbuk Samsung Hospital
03181 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Kunkuk University Medical Center
05030 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Pusan National University Yangsan Hospital
50612 Yangsan
Korea, Republic ofRekrutierend» Google-Maps
The Dutch Cancer Institue
1066 CX Amsterdam
NetherlandsAbgeschlossen» Google-Maps
Leids Universitair Medisch Centrum (Lumc) (Leiden University Medical Center)
02333 Leiden
NetherlandsAbgeschlossen» Google-Maps
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka
85-796 Bydgoszcz
PolandNoch nicht rekrutierend» Google-Maps
Przychodnia Lekarska Komed Roman Karaszewski
62-500 Konin
PolandNoch nicht rekrutierend» Google-Maps
Centrum Onkologii Ziemi Lubelskiej Im. SW. Jana Z Dukli
20-090 Lublin
PolandNoch nicht rekrutierend» Google-Maps
Poznan University of Medical Sciences
60-780 Poznan
PolandNoch nicht rekrutierend» Google-Maps
Nzoz Provita Prolife Centrum Medyczne
97-200 Tomaszow Mazowiecki
PolandNoch nicht rekrutierend» Google-Maps
Centrum Onkologii - Instytut Im. Marii Sklodowskiej - Curie
02-781 Warszawa
PolandNoch nicht rekrutierend» Google-Maps
Centro Hospitalar Universitario Algarve
8000-386 Faro
PortugalRekrutierend» Google-Maps
Centro Hospitalar de Lisboa Norte E.P.E. - Hospital de Santa Maria
1649-035 Lisboa
PortugalRekrutierend» Google-Maps
Instituto Portugues de Oncologia Do Porto Francisco Gentil E.P.E.
4200-072 Porto
PortugalRekrutierend» Google-Maps
Centro Hospitalar de Sao Joao Alameda
4200-319 Porto
PortugalRekrutierend» Google-Maps
Centro Hospitalar de Vila Nova de Gaia/Espinho, Epe-Unidade L
4434-502 Vila Nova de Gaia
PortugalRekrutierend» Google-Maps
Catalans Institute of Oncology Barcelona
08916 Barcelona
SpainRekrutierend» Google-Maps
Ico Girona Hospital Universitari de Girona Dr Josep Trueta
17007 Girona
SpainRekrutierend» Google-Maps
Fundacion Jimenez Diaz University Hospital
00034 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Ramon Y Cajal
28036 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Quironsalud Madrid
28223 Madrid
SpainRekrutierend» Google-Maps
Hospital Regional Universitario Carlos Haya
29010 Malaga
SpainRekrutierend» Google-Maps
Complejo Hospitalario de Navarra
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitario Marques de Valdecilla
39008 Santander
SpainRekrutierend» Google-Maps
Hospital General Universitario de Valencia
46014 Valencia
SpainRekrutierend» Google-Maps
Hospital Universitari I Politecnic La Fe
46026 Valencia
SpainRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital
80708 Kaohsiung City
TaiwanRekrutierend» Google-Maps
Chang Gung Medical Foundation. Kaohsiung Branch
83301 Kaohsiung
TaiwanRekrutierend» Google-Maps
China Medical University Hospital
00112 Taichung City
TaiwanRekrutierend» Google-Maps
Institutional Review Board Taipei Veterans General Hospital
00112 Taipei
TaiwanRekrutierend» Google-Maps
National Taiwan University Hospital
10002 Taipei
TaiwanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to evaluate the safety and efficacy of the combination of

retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with

retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive

recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy

with curative intent. Participants who refuse potentially curative salvage surgery for

recurrent disease are ineligible.

- Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.

- Participants must not have received prior systemic therapy for R/M SCCHN.

- PD-L1 positive tumor status defined by CPS ≥ 1% per central laboratory determination.

- For participants with primary oropharyngeal tumors, documentation of HPV p16 status

based on local institutional standard is required. HPV p16 status is not required for

other eligible SCCHN primary tumor sites.

- Participant must have at least 1 measurable tumor lesion per RECIST v1.1.

- Availability of archival tissue for biomarker analysis from a core or excisional

biopsy or willingness to undergo a fresh biopsy.

- ECOG performance status of 0 or 1.

- Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

- Progressive or recurrent disease within 6 months of the last dose of systemic

treatment for locally advanced SCCHN. Prior PD-(L)1, LAG-3, or TIM-3 directed therapy,

or any other checkpoint inhibitor therapy, for SCCHN or any other malignancy.

- Treatment with anticancer therapies or participation in another interventional

clinical study within 21 days before the first administration of study treatment.

- Presence of tumors that invade major blood vessels, as shown unequivocally by imaging,

and with active bleeding.

- Participants with primary tumors of the nasopharynx, sinonasal cavity, or salivary and

are excluded.

- Less than 3-month life expectancy.

- Participant has not recovered to ≤ Grade 1 or baseline from residual toxicities of

prior therapy.

- Participant has not recovered adequately from toxicities and/or complications from

surgical intervention before starting study treatment.

- Palliative radiation therapy administered within 1 week before the first dose of study

treatment or radiation therapy in the thoracic region that is > 30 Gy within 6 months

before the first dose of study treatment.

- Known active CNS metastases and/or carcinomatous meningitis. Participants will be

excluded if it has been < 4 weeks since radiation therapy was delivered to the CNS.

Studien-Rationale

Primary outcome:

1. Progression Free Survival (PFS) (Time Frame - Up to 24 months):
Defined as the interval between the date of first dose of study treatment and the earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death due to any cause.



Secondary outcome:

1. Objective Response Rate (ORR) (Time Frame - Up to 24 months):
Defined as having a Complete Response (CR) or Partial Response (PR), determined based on investigator assessment per RECIST v1.1.

2. Duration of Response (DOR) (Time Frame - Up to 24 months):
Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, based on investigator assessment per RECIST v1.1, or death from any cause if occurring sooner than progression.

3. Disease Control Rate (DCR) (Time Frame - Up to 24 months):
Defined as having CR, PR, or SD (≥ 6 months) as best response, based on investigator assessment per RECIST v1.1.

4. Overall Survival (OS) (Time Frame - Up to 36 months):
Defined as the interval between the date of the date of first dose of study treatment until death due to any cause.

5. Participants with treatment-emergent adverse events (TEAE) (Time Frame - Up to 24 months):
TEAE is defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug

Studien-Arme

  • Experimental: Treatment Group 1: Retifanlimab Monotherapy
    Retifanlimab will be administered intravenously every 4 weeks. Placebos for INCAGN02385 and INCAGN02390 will be administered intravenously every 2 weeks.
  • Experimental: Treatment Group 2: Retifanlimab + INCAGN02385
    Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and Placebo for INCAGN02390 will be administered intravenously every 2 weeks.
  • Experimental: Treatment Group 3: Retifanlimab + INCAGN02385 + INCAGN02390
    Retifanlimab plus INCAGN02385 and INCAGN02390 will be administered intravenously. Retifanlimab will be administered intravenously every 4 weeks. INCAGN02385 and INCAGN02390 will be administered every 2 weeks.

Geprüfte Regime

  • Retifanlimab:
    Retifanlimab 500mg will be administered intravenously every 4 weeks.
  • INCAGN02385:
    INCAGN02385 350mg will be administered intravenously every 2 weeks.
  • INCAGN02390:
    INCAGN02390 400 mg will be administered intravenously every 2 weeks.
  • Placebo:
    Placebo will be administered intravenously.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck"

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.