A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Condition(s) studied
Investigational drug(s) / intervention(s)
zolbetuximab: Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Each cycle was approximately 42 days.
placebo: Participants received an IV infusion (as a minimum of 2-hour infusion) of placebo matched to zolbetuximab on C1D1 followed by subsequent doses every 3 weeks starting from C1D22 until participant met study treatment discontinuation criteria. Each cycle was approximately 42 days.
oxaliplatin: Participants received up to 12 treatments of oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours) on Days 1, 15 and 29 of each cycle.. A maximum of 12 doses of oxaliplatin was permitted. Each cycle was approximately 42 days.
folinic acid: Participants received up to 12 treatments of folinic acid administered 400 mg/m\^2 IV infusion over 2 hours 4 or more cycles on Days 1, 15 and 29 of each cycle. participants could continue to receive folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
fluorouracil: Participants received up to 12 treatments of 5-fluorouracil over 4 or more cycles administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Participants could continue to receive 5-fluorouracil on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
Study summary
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Most people with this type of cancer have a protein called Claudin 18.2 in their tumor. Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's immune system to attack the tumor. There is an unmet medical need to treat people with advanced stomach cancer or GEJ cancer. This study will give more information about how well zolbetuximab works when given with chemotherapy in adults with advanced stomach cancer or GEJ cancer. In this study, adults with advanced stomach cancer or GEJ cancer will either be given zolbetuximab with chemotherapy or a placebo with chemotherapy. A placebo looks like zolbetuximab but doesn't have any medicine in it. Zolbetuximab with chemotherapy has already been approved to treat gastric cancer and GEJ cancer in some countries. This study is being done in countries where zolbetuximab has not yet been approved for use. If zolbetuximab becomes approved for use in those countries taking part in this study, the study doctor will switch study treatment in those countries to the licensed zolbetuximab. If this happens, people taking part in those countries will leave this study and receive licensed zolbetuximab.
The main aim of the study is to check if zolbetuximab and chemotherapy can prevent or delay the worsening of people's gastric cancer and GEJ cancer compared to placebo and chemotherapy.
Adults with advanced stomach cancer or GEJ cancer can take part. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. A tumor sample of their cancer will also have the Claudin 18.2 protein. They may have been previously treated with certain standard therapies, but have not been treated with chemotherapy for their cancer. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers such as symptomatic or untreated cancers in the nervous system, or have a specific heart condition, or infections.
The study treatments are either zolbetuximab with chemotherapy, or placebo with chemotherapy. People who take part will receive just 1 of the study treatments by chance. Study treatment will be double-blinded. That means that the people in the study and the study doctors will not know who takes which of the study treatments. Study treatment will be given in cycles. The study treatment is given to people slowly through a tube into a vein. This is called an infusion. People will have 4 infusions in 6-week (42-day) cycles as follows:
* Zolbetuximab or placebo - 2 infusions in a cycle.
* Chemotherapy (called modified FOLFOX6 or mFOLFOX6) - 3 infusions in a cycle. The first infusion is combined with zolbetuximab or placebo on day 1 of each cycle. People may receive zolbetuximab or placebo until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People will receive mFOLFOX6 for up to 6 months (4 study treatment cycles). After the 6 months people may receive chemotherapy containing folinic acid and fluorouracil instead of mFOLFOX6. People may receive folinic acid and fluorouracil chemotherapy for more than 6 months, or until their cancer worsens, they cannot tolerate the study treatment, or they need to start another cancer treatment. People will visit the clinic on certain days during their study treatment. The study doctors will check if people had any medical problems from taking zolbetuximab or the other study treatments. Also, people in the study will have health checks. On some visits they will have scans to check for any changes in their cancer. People will have the option of giving a tumor sample after their study treatment has finished. People will visit the clinic after they stop their study treatment. People who start treatment with licensed zolbetuximab or mFOLFOX6 outside of this study will not need to visit the clinic. People will be asked about any medical problems and will have a health check. People will visit the clinic at 1 month after they stop their study treatment. People will continue to have scans every 9 or 12 weeks to check for any changes in their cancer. People will have telephone health checks every 3 months. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their study treatment or not.
Eligibility
Primary outcome measure(s)
- Progression Free Survival (PFS) — From date of randomization until the date of first documented radiological progression or date of death from any cause, whichever occurred first (up to 62 months and 18 days)
PFS was defined as the time from the date of randomization until the date of radiological progressive disease (PD) (per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 by independent review committee \[IRC\]) or death from any cause, whichever was earliest. PD was defined as development of new, or progression of existing metastases to the primary cancer under the study. Kaplan -Meier (KM) estimates was used.
Trial sites (220)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona | Phoenix | Arizona | |
| The University of Arizona Medical Center | Tucson | Arizona | |
| CBCC Global Research, Inc. at Comprehensive Blood and Cancer | Bakersfield | California | |
| City of Hope Nat'l Medical Center | Duarte | California | |
| St. Jude Hospital Yorba Linda | Fullerton | California | |
| Pacific Shores Medical Group | Huntington Beach | California | |
| Loma Linda University | Loma Linda | California | |
| The Angeles Clinic and Research Institute | Los Angeles | California | |
| University of California Davis | Sacramento | California | |
| University of California - San Francisco | San Francisco | California | |
| University of Colorado | Aurora | Colorado | |
| Memorial Sloan Kettering Cancer Center | Middletown | Connecticut | |
| Memorial Cancer Institute - West | Hollywood | Florida | |
| University of Miami | Miami | Florida | |
| Orlando Health Inc | Orlando | Florida | |
| Memorial Hospital West | Pembroke Pines | Florida | |
| Cancer Treatment Centers of America, Atlanta | Newnan | Georgia | |
| Northwestern University Medical Center | Chicago | Illinois | |
| University of Chicago | Chicago | Illinois | |
| Norton Cancer Institute | Louisville | Kentucky | |
| University of Maryland Medical Center(UMMC)Transplant Center | Baltimore | Maryland | |
| Maryland Oncology Hematology | Brandywine | Maryland | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Karmanos Cancer Institute | Detroit | Michigan | |
| Health Partners Institute | Saint Louis Park | Minnesota | |
| Regions Hospital | Saint Paul | Minnesota | |
| Memorial Sloan Kettering Cancer Center | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering Cancer Center | Montvale | New Jersey | |
| Roswell Park Cancer Institute | Buffalo | New York | |
| Memorial Sloan Kettering Cancer Center | Commack | New York | |
| Memorial Sloan Kettering Cancer Center | Harrison | New York | |
| Mount Sinai School of Medicine | New York | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Stony Brook University Medical Center | Stony Brook | New York | |
| Memorial Sloan Kettering Cancer Center | Uniondale | New York | |
| The Ohio State University Medical Center | Columbus | Ohio | |
| Precision Cancer Research -Dayton Physicians Network | Middletown | Ohio | |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma |
+ 180 more sites — see the full list on the official registry below.
More Astellas Pharma Global Development, Inc. trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03504397 on ClinicalTrials.gov ↗ ← All trials in Belgium