JOURNAL ONKOLOGIE – STUDIE

ARTEMIDE-Bil01

Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06109779

Studienbeginn:
Dezember 2023

Letztes Update:
03.04.2024

Wirkstoff:
Rilvegostomig, Placebo, Capecitabine, Gemcitabine/Cisplatin, S-1 [Tegafur/Oteracil/gimeracil]

Indikation (Clinical Trials):
Biliary Tract Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
AstraZeneca

Collaborator:
-

Kontakt

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

Studienlocations
(3 von 158)

Research Site
13353 Berlin
(Berlin)
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Research Site
53127 Bonn
(Nordrhein-Westfalen)
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44137 Dortmund
(Nordrhein-Westfalen)
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01307 Dresden
(Sachsen)
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91054 Erlangen
(Bayern)
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45122 Essen
(Nordrhein-Westfalen)
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73730 Esslingen
(Baden-Württemberg)
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60488 Frankfurt
(Hessen)
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22763 Hamburg
(Hamburg)
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69120 Heidelberg
(Baden-Württemberg)
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50937 Köln
(Nordrhein-Westfalen)
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4103 Leipzig
(Sachsen)
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23538 Luebeck
(Schleswig-Holstein)
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81377 München
(Bayern)
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81737 München
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48149 Münster
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70174 Stuttgart
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89081 Ulm
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35233 Birmingham
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85054 Phoenix
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90089 Los Angeles
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92868 Orange
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94305 Stanford
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90048 West Hollywood
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80045 Aurora
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20007 Washington
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32611 Gainesville
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32224 Jacksonville
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60637 Chicago
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52242 Iowa City
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66160 Kansas City
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40506 Lexington
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70121 New Orleans
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21201 Baltimore
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55905 Rochester
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63110 Saint Louis
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11725 Commack
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11501 Mineola
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19111 Philadelphia
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19144 Philadelphia
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75246 Dallas
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75702 Tyler
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98684 Vancouver
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3168 Clayton
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6150 Murdoch
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3021 Reservoir
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2145 Westmead
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1070 Brussels
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1200 Bruxelles
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2650 Edegem
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3000 Leuven
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59075-740 Natal
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90035-000 Porto Alegre
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91350-200 Porto Alegre
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97015-450 Santa Maria
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2730 Herlev
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13273 Marseille
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75248 Paris Cedex 5
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33604 Pessac
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35000 Rennes
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67033 Strasbourg
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31059 Toulouse Cedex 9
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94800 Villejuif
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00000 Hong Kong
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110088 Delhi
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700094 Kolkata
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400012 Mumbai
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570017 Mysuru
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110076 New Delhi
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110085 New Delhi
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391760 Vadodara
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221005 Varanasi
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50134 Firenze
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20133 Milano
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20162 Milano
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35128 Padova
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56126 Pisa
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20089 Rozzano
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73039 Tricase, Lecce
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104-0045 Chuo-ku
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227-8577 Kashiwa
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362-0806 Kitaadachi-gun
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464-8681 Nagoya-shi
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541-8567 Osaka-shi
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565-0871 Suita-shi
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241-8515 Yokohama-shi
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13620 Seongnam-si
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03080 Seoul
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03722 Seoul
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05505 Seoul
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06351 Seoul
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06591 Seoul
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450 Oslo
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85-796 Bydgoszcz
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40-514 Katowice
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31-501 Kraków
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20-081 Lublin
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37-700 Przemysl
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97-200 Tomaszów Mazowiecki
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02-034 Warszawa
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08036 Barcelona
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8035 Barcelona
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08908 L'Hospitalet de Llobregat
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28007 Madrid
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28040 Madrid
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28041 Madrid
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29011 Málaga
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31005 Pamplona
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39008 Santander
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82445 Kaohsiung
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83301 Kaohsiung
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40447 Taichung
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40705 Taichung
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70403 Tainan City
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10002 Taipei
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112 Taipei
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333 Taoyuan
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90110 Hat Yai
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40002 Khon Kaen
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34000 Muang
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50200 Muang
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30000 Naimuang
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33000 Sisaket
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06100 Ankara
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06230 Ankara
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06620 Ankara
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07100 Antalya
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25240 Erzurum
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34098 Fatih-Istanbul
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34722 Istanbul
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55270 Samsun
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CB2 0QQ Cambridge
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B15 2WB Edgbaston
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G12 0YN Glasgow, Scotland
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NW3 2QG London
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W12 0HS London
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WC1E 6BT London
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M20 4BX Manchester
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SM2 5PT Sutton
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Alle anzeigen

Studien-Informationen

Detailed Description:

This is a Phase III, randomized, double-blind, placebo-controlled, multicenter, global study

to assess the efficacy and tolerability of rilvegostomig compared to placebo in combination

with investigator's choice of chemotherapy (capecitabine, S-1(tegafur/ gimeracil/ oteracil)

or gemcitabine/cisplatin) as adjuvant treatment in participants with BTC after resection with

curative intent. This study will be conducted in patients with BTC who are at risk of

recurrence after resection with curative intent.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Histologically confirmed adenocarcinoma of the biliary tract (intrahepatic or

extrahepatic) after macroscopically complete resection (R0 or R1)

- Provision of a tumor sample collected at surgical resection.

- Randomization within 12 weeks after resection with adequate healing and removal of

drains.

- Confirmed to be disease-free by imaging within 28 days prior to randomization.

- Eastern Cooperative Oncology Group performance status of 0 or 1

Exclusion Criteria:

- Participants with locally-advanced, unresectable, or metastatic disease at initial

diagnosis.

- Ampullary cancer, neuroendocrine, mixed neuroendocrine and non-neuroendocrine

neoplasms and nonepithelial tumors.

- Any anti-cancer therapy for BTC prior to surgery

- Active or prior documented autoimmune or inflammatory disorders or any severe or

uncontrolled systemic disease

- Current or prior use of immunosuppressive medication within 14 days before the first

dose

- Thromboembolic event within 3 months

- Active HBV or HCV infection unless treated.

Studien-Rationale

Primary outcome:

1. Recurrence free survival (RFS) for Arm A vs. Arm B (Time Frame - Approximately 5 years):
Recurrence-free survival (RFS) is defined as the time from randomization until the date of radiological recurrence guided by RECIST 1.1 or death due to any cause, whichever occurs first.

Secondary outcome:

1. Overall Survival (OS) for Arm A vs. Arm B (Time Frame - up to 7 years):
Overall survival is defined as the time from randomization until the date of death due to any cause.

Studien-Arme

Experimental: Arm A
Rilvegostomig IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)
Placebo Comparator: Arm B
Placebo IV infusion + Investigator choice of chemotherapy (Capecitabine or Gemcitabine/Cisplatin or S-1)

Geprüfte Regime

Rilvegostomig:
Rilvegostomig IV (intravenous) Q3W
Placebo:
Placebo IV (intravenous) Q3W
Capecitabine:
Capecitabine (Oral) 1250 mg/m2 BID (twice daily) for 2 weeks on/1 week off in 21-day cycles or per local practice
Gemcitabine/Cisplatin:
Gemcitabine/Cisplatin IV (Intravenous) 1000 mg/m2 plus cisplatin 25 mg/m2 on Day 1 and Day 8 of each 21-day cycle
S-1 [Tegafur/Oteracil/gimeracil]:
S-1 [Tegafur/Oteracil/gimeracil] (Oral) BSA (body surface area)-based (40, 50, or 60 mg) BID for 4 weeks on 2 weeks off in 42-day cycles

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Rilvegostomig + Chemotherapy as Adjuvant Therapy for Biliary Tract Cancer After Resection (ARTEMIDE-Biliary01)"

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