500
Participants
Start Date
May 22, 2025
Primary Completion Date
December 31, 2029
Study Completion Date
December 31, 2029
zolbetuximab
Participants will receive an IV infusion of zolbetuximab on Cycle 1 Day 1 (C1D1) followed by subsequent IV infusion every 2 weeks or every 3 weeks.
Pembrolizumab
Participants will receive an IV infusion of pembrolizumab every 3 weeks or every 6 weeks.
Capecitabine
Participants receiving CAPOX regimen of chemotherapy will receive capecitabine Tablet twice daily orally on days 1 through 14 and days 22 through 35 of each cycle.
Oxaliplatin
Participants receiving CAPOX or mFOLFOX6 regimen of chemotherapy will receive an IV infusion of oxaliplatin once every 2 or 3 weeks.
Folinic acid (leucovorin or local equivalent)
Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion of Folinic acid (leucovorin or local equivalent) once every 2 weeks.
5-fluorouracil (5-FU)
Participants receiving mFOLFOX6 regimen of chemotherapy will receive an IV infusion, or IV bolus of 5-FU once every 2 weeks.
Placebo
Participants will receive an IV infusion of placebo (0.9% of sodium chloride) on C1D1 followed by subsequent IV infusion every 2 weeks or every 3 weeks.
RECRUITING
NYU Langone Medical Center, New York
RECRUITING
The University of Tennessee Medical Center, Knoxville
RECRUITING
Holden Comprehensive Cancer Center, Iowa City
RECRUITING
Metro Minnesota Community Oncology Research Consortium (MMCORC), Saint Louis Park
RECRUITING
Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha
RECRUITING
The Center For Cancer And Blood Disorders (Texas Cancer Care), Fort Worth
RECRUITING
Dana Farber/Harvard Cancer Center, Boston
RECRUITING
FR33003, Paris
RECRUITING
FR33010, Paris
RECRUITING
FR33013, Paris
RECRUITING
FR33006, Rouen
RECRUITING
DE49002, Saarbrücken
RECRUITING
DE49011, Schweinfurt
RECRUITING
IT39009, Brescia
RECRUITING
IT39007, Meldola
RECRUITING
Chiba Cancer Center, Chiba
RECRUITING
National Cancer Center Hospital East, Kashiwa
RECRUITING
National Hospital Organization Shikoku Cancer Center, Matsuyama
RECRUITING
Kyushu University Hospital (Hematology, Oncology & Cardiovascular medicine), Fukuoka
RECRUITING
Kyushu University Hospital(Gastrointestinal Surgery), Fukuoka
RECRUITING
National Hospital Organization Kyushu Cancer Center, Fukuoka
RECRUITING
Gunma University Hospital, Maebashi
RECRUITING
Hokkaido University Hospital, Sapporo
RECRUITING
Hyogo Cancer Center, Akashi-shi
RECRUITING
Kobe City Medical Center General Hospital, Kobe
RECRUITING
Kagawa University Hospital, Kida-gun
RECRUITING
St. Marianna University Hospital, Kawasaki-shi
RECRUITING
Kanagawa Cancer Ctr Hospital, Yokohama
RECRUITING
Osaka General Medical Center, Osaka
RECRUITING
Osaka University Hospital, Suita-shi
RECRUITING
Saitama Medical University International Medical Center, Hidaka-shi
RECRUITING
Shizuoka Cancer Center, Sunto-gun
RECRUITING
National Cancer Center Hospital, Chuo-ku
RECRUITING
The Cancer Institute Hospital of JFCR, Koto-ku
RECRUITING
LT37001, Kaunas
RECRUITING
LT37002, Vilnius
RECRUITING
NL31001, Nijmegen
RECRUITING
PL48001, Brzozów
RECRUITING
PL48008, Olsztyn
RECRUITING
PL48002, Przemyśl
RECRUITING
PL48007, Warsaw
RECRUITING
RO40001, Cluj-Napoca
RECRUITING
RO40006, Cluj-Napoca
RECRUITING
RO40002, Floreşti
RECRUITING
RO40007, Iași
RECRUITING
RO40004, Timișoara
RECRUITING
KR82011, Goyang-si
RECRUITING
KR82007, Seongnam-si
RECRUITING
KR82013, Suwon
RECRUITING
KR82015, Suwon
RECRUITING
KR82014, Hwasungun
RECRUITING
KR82009, Cheongju-si
RECRUITING
KR82004, Daegu
RECRUITING
KR82005, Incheon
RECRUITING
KR82001, Seoul
RECRUITING
KR82002, Seoul
RECRUITING
KR82006, Seoul
RECRUITING
KR82010, Seoul
RECRUITING
KR82012, Seoul
RECRUITING
ES34027, Madrid
RECRUITING
ES34002, Navarra
RECRUITING
ES34006, Barcelona
RECRUITING
ES34014, Lleida
RECRUITING
ES34008, Madrid
RECRUITING
ES34016, Madrid
RECRUITING
ES34017, Madrid
RECRUITING
ES34013, Pozuelo de Alarcón
RECRUITING
ES34012, Seville
RECRUITING
ES34025, Seville
RECRUITING
ES34004, Valencia
RECRUITING
TW88604, Kaohsiung City
RECRUITING
UK44001, Bristol
RECRUITING
UK44006, Dundee
RECRUITING
UK44011, London
RECRUITING
UK44014, London
RECRUITING
UK44015, London
RECRUITING
UK44016, London
RECRUITING
UK44009, Manchester
Astellas Pharma Global Development, Inc.
INDUSTRY