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JOURNAL ONKOLOGIE – STUDIE
AZUR-1

A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer

Rekrutierend

NCT-Nummer:
NCT05723562

Studienbeginn:
April 2023

Letztes Update:
20.02.2024

Wirkstoff:
Dostarlimab

Indikation (Clinical Trials):
Rectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
GlaxoSmithKline

Collaborator:
-

Studienleiter

GSK Clinical Trials
Study Director
GlaxoSmithKline

Kontakt

EU GSK Clinical Trials Call Center
Kontakt:
Phone: +44 (0) 20 89904466
E-Mail: GSKClinicalSupportHD@gsk.com» Kontaktdaten anzeigen

Studienlocations
(3 von 62)

GSK Investigational Site
81377 Muenchen
(Bayern)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
60488 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
40225 Duesseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
01307 Dresden
(Sachsen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
13353 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
72205 Little Rock
United StatesRekrutierend» Google-Maps
Ansprechpartner:
US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
90027 Los Angeles
United StatesRekrutierend» Google-Maps
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
95817 Sacramento
United StatesRekrutierend» Google-Maps
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
90602 Whittier
United StatesRekrutierend» Google-Maps
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
20010 Washington
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
30322 Atlanta
United StatesRekrutierend» Google-Maps
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
60612 Chicago
United StatesRekrutierend» Google-Maps
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
46237 Indianapolis
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
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GSK Investigational Site
52242-1009 Iowa City
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
21215 Baltimore
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
02215 Boston
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
48202 Detroit
United StatesRekrutierend» Google-Maps
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
64128 Kansas City
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
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GSK Investigational Site
63110 Saint Louis
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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GSK Investigational Site
87131 Albuquerque
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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GSK Investigational Site
10022 New York
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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GSK Investigational Site
27834 Greenville
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E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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GSK Investigational Site
15232 Pittsburgh
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
37203 Nashville
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
79106 Amarillo
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
75235 Dallas
United StatesRekrutierend» Google-Maps
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
75390 Dallas
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
23298 Richmond
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
K1H 8L6 Ottawa
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US GSK Clinical Trials Call Center
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E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
M5G 2M9 Toronto
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US GSK Clinical Trials Call Center
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E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
H2X 0A9 Montréal
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
J1H 5N4 Sherbrooke
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
25030 Besançon cedex
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
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GSK Investigational Site
13273 Marseille Cedex 9
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
75012 Paris
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
33604 Pessac cedex
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
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GSK Investigational Site
35000 Rennes
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
80131 Napoli
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
00168 Roma
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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GSK Investigational Site
20133 Milano
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
20162 Milano
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Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
56126 Pisa
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Phone: 877-379-3718
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GSK Investigational Site
35128 Padova
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GSK Investigational Site
277-8577 Chiba
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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GSK Investigational Site
232-0024 Kanagawa
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
540-0006 Osaka
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
565-0871 Osaka
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
03080 Seoul
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
05505 Seoul
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Phone: 877-379-3718
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GSK Investigational Site
06591 Seoul
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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GSK Investigational Site
120-752 Seoul
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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GSK Investigational Site
135-710 Seoul
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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GSK Investigational Site
3584 CX Utrecht
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
08035 Barcelona
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
18014 Granada
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
28007 Madrid
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
28041 Madrid
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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GSK Investigational Site
39008 Santander
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GSK Investigational Site
46010 Valencia
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
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EU GSK Clinical Trials Call Centre
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GSK Investigational Site
SM2 5PT Sutton
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
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GSK Investigational Site
LS9 7TF Leeds
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre
Phone: +44 (0) 20 8990 4466
E-Mail: GSKClinicalSupportHD@gsk.com» Ansprechpartner anzeigen
GSK Investigational Site
EC1A 7BE London
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US GSK Clinical Trials Call Center
Phone: 877-379-3718
E-Mail: GSKClinicalSupportHD@gsk.com

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Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to investigate dostarlimab monotherapy in participants with

locally advanced Mismatch-repair deficient (dMMR)/Microsatellite instability-high (MSI-H)

rectal cancer who have received no prior treatment. Participants who achieve complete

clinical response (cCR) following dostarlimab treatment will undergo non-operative management

(NOM), including close surveillance for recurrent disease. The goal of the study is to

determine if Dostarlimab therapy alone is an effective treatment that can allow participants

to avoid chemotherapy, radiation, and surgery.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participant has histologically confirmed Stage II to III (T3-T4, N0, or T any, N+),

locally advanced rectal cancer

- Participant has radiologically and endoscopically evaluable disease.

- Participant has a tumor which can be categorized as dMMR or MSI-H by local or central

assessment

Exclusion Criteria:

- Participant has distant metastatic disease.

- Participant has received prior radiation therapy, systemic therapy, or surgery for

management of rectal cancer.

- Participant has any history of interstitial lung disease or pneumonitis

- Participant has experienced any of the following with prior immunotherapy: any irAE of

Grade ≥3, immune-related severe neurologic events of any grade (e.g., myasthenic

syndrome/myasthenia gravis, encephalitis, Guillain Barré Syndrome, or transverse

myelitis), exfoliative dermatitis of any grade (Stevens-Johnson Syndrome, toxic

epidermal necrolysis, or DRESS syndrome), or myocarditis of any grade. Non clinically

significant laboratory abnormalities are not exclusionary.

- Participant has a known additional malignancy that progressed or required active

treatment within the past 2 years. Exceptions include adequately treated superficial

skin cancers, superficial bladder cancers, and other in situ cancers.

- Participant has an active autoimmune disease that has required systemic treatment in

the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or

immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or

physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency)

is not considered a form of systemic treatment.

- Participant has a history of severe allergic and/or anaphylactic reactions to

chimeric, human or humanized antibodies, fusion proteins, or has known allergies to

dostarlimab or its excipients.

- Has received or plans to receive an organ or stem cell transplant that uses donor stem

cells (allogeneic stem cell transplant).

Studien-Rationale

Primary outcome:

1. Number of Participants with Sustained Complete Clinical Response for 12 Months (cCR12) as assessed by Independent Central Review (ICR) (Time Frame - 18 Months):
cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 12 months following their post-intervention disease assessment (PIDA)



Secondary outcome:

1. Number of Participants with Sustained Complete Clinical Response for 24 Months (cCR24) as assessed by ICR (Time Frame - 30 Months):
cCR24 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 24 months following their post-Intervention disease assessment (PIDA)

2. Number of Participants with Sustained Complete Clinical Response for 36 Months (cCR36) as assessed by ICR (Time Frame - 42 Months):
cCR36 is achieved when a participant maintains complete clinical response (cCR) as assessed by ICR for 36 months following their post-Intervention disease assessment (PIDA)

3. Number of Participants with Event Free Survival at 3 years (EFS3) as assessed by Investigator (Time Frame - 3 years):
EFS3 is defined as participants who remained alive and free of disease progression precluding surgery, local recurrence, and distant recurrence at 3 years as assessed by Investigator

4. Event Free Survival (EFS) as assessed by Investigator (Time Frame - Up to 74 months):
EFS is defined as time from the date of first dose of study intervention to any of the following events: progression of disease that precludes surgery, local recurrence, distant recurrence (all as assessed by the investigator), or death due to any cause

5. Number of Participants with cCR12 as assessed by Investigator (Time Frame - 18 Months):
cCR12 is achieved when a participant maintains complete clinical response (cCR) as assessed by Investigator for 12 months following their post-intervention disease assessment (PIDA)

6. Number of Participants with cCR24 as assessed by Investigator (Time Frame - 30 Months):
cCR24 is achieved when a participant maintains complete clinical response (cCR) as assessed by Investigator for 24 months following their post-intervention disease assessment (PIDA)

7. Number of Participants with cCR36 as assessed by Investigator (Time Frame - 42 Months):
cCR36 is achieved when a participant maintains complete clinical response (cCR) as assessed by Investigator for 36 months following their post-intervention disease assessment (PIDA)

8. Objective Response Rate (ORR) assessed by ICR (Time Frame - Up to 33 Weeks):
ORR is defined as number of participants achieving a partial response (PR), near complete response (nCR) or complete clinical response (cCR) at PIDA or at least 4 weeks but no longer than 8 weeks after PIDA for participants with nCR or incomplete clinical response (iCR) (PIDA 2) as assessed by ICR

9. Objective Response Rate (ORR) as assessed by Investigator (Time Frame - Up to 33 Weeks):
ORR by Investigator, defined as achieving a PR, nCR, or cCR at PIDA or at least 4 weeks but no longer than 8 weeks after PIDA for participants with nCR or iCR

10. Organ Preservation Rate (Time Frame - 3 years):
Organ Preservation Rate defined as not undergoing Total Mesorectal Excision (TME), either as primary management or for local recurrence, or who did not have a permanent colostomy created, at any time up to 3 years

11. Disease-Specific Survival (DSS) (Time Frame - Up to 74 months):
DSS is defined as time from the date of first dose of study intervention to death due to disease

12. Disease-Specific Response at 5 years (DSS5) (Time Frame - Up to 5 years):
DSS5 is defined as the number of participants not dying due to disease under study at 5 years from the first dose of study intervention

13. Overall Survival (OS) (Time Frame - Up to 74 months):
OS is defined as time from first dose of study intervention to death from any cause

14. Overall Survival at 5 years (OS5) (Time Frame - Up to 5 years):
OS is defined as number of participants as being alive at 5 years from first dose of study intervention

15. Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Immune related Adverse Events (irAEs) based on Severity (Time Frame - Up to 74 months)

16. Number of Participants with discontinuation of study intervention (Time Frame - Up to 24 weeks)

17. Serum concentration of Dostarlimab (Time Frame - Up to 37 weeks)

18. Concentration at the end of infusion (C-EOI) of Dostarlimab (Time Frame - Up to 37 weeks)

19. Trough Concentration (C-trough) of Dostarlimab (Time Frame - Up to 37 weeks)

20. Number of Participants with Anti-Drug Antibodies against Dostarlimab (Time Frame - Up to 37 weeks)

Geprüfte Regime

  • Dostarlimab (JEMPERLI / dostarlimab-gxly / TSR-042 / GSK4057190A / ):
    Dostarlimab will be administered.

Quelle: ClinicalTrials.gov


Sie können folgenden Inhalt einem Kollegen empfehlen:

"A Study of Dostarlimab in Untreated dMMR/MSI-H Locally Advanced Rectal Cancer"

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