Study of Zolbetuximab with Pembrolizumab and Chemotherapy for Adults with Stomach Cancer
Sponsor: Astellas Pharma Global Development, Inc.
ClinicalTrials ID:NCT06901531
This clinical trial is testing a new treatment combination of zolbetuximab, pembrolizumab, and chemotherapy for adults with stomach or gastroesophageal junction (GEJ) cancer. The study aims to see if this combination helps patients live longer compared to a placebo with pembrolizumab and chemotherapy.
Patient Parameters
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Program Overview
Zolbetuximab is being studied for its potential to treat stomach and GEJ cancer by targeting a protein called Claudin 18.2 on cancer cells. This study will compare the effects of zolbetuximab combined with pembrolizumab and chemotherapy against a placebo with pembrolizumab and chemotherapy. The main goal is to see if patients live longer with the zolbetuximab combination. Participants will be randomly assigned to receive either the zolbetuximab combination or the placebo combination. The study involves regular infusions and health checks over 6-week cycles, with treatment continuing until the cancer worsens or other conditions apply.
Description
Zolbetuximab, approved in Japan, is being tested in combination with pembrolizumab and chemotherapy for treating stomach and GEJ cancer. Participants will receive either zolbetuximab or a placebo, along with pembrolizumab and chemotherapy, in cycles. The study aims to determine if this combination helps patients live longer. Participants will have regular clinic visits for treatment and health checks, including scans to monitor cancer progression. The study will continue until the cancer worsens, the treatment is not tolerated, or another treatment is needed. Pembrolizumab may be given for up to 2 years. After stopping treatment, participants will have follow-up visits and scans to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Adults with confirmed stomach or GEJ cancer that is locally advanced, cannot be removed by surgery, or has spread to other parts of the body.
- Cancer must be HER2-negative and express Claudin 18.2 and PD-L1 proteins.
- Must be able to receive mFOLFOX6 or CAPOX chemotherapy and pembrolizumab.
- Good overall health with a life expectancy of at least 12 weeks.
- Women must not be pregnant or breastfeeding and must agree to use contraception.
- Men must agree to use contraception and not donate sperm during and after treatment.
- Must not participate in another interventional study while receiving treatment in this study.
Exclusion Criteria
- Severe allergic reactions to study drugs or similar medications.
- Complete or partial gastric outlet syndrome with persistent vomiting.
- Significant gastric bleeding or untreated ulcers.
- Unresolved lung inflammation or history of certain lung conditions.
- History of brain or spinal cord cancer spread.
- Active infections like HIV, hepatitis B or C, or tuberculosis.
- Active autoimmune diseases requiring recent treatment.
- Other significant health conditions that may affect treatment safety.
- Previous treatment with certain chemotherapy or immunotherapy drugs, except under specific conditions.
- Recent major surgery or radiation therapy without full recovery.
- Previous treatment with CLDN18.2 agents or recent live vaccines.
- Any condition that makes participation unsafe or complicates data interpretation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale University School of Medicine | 06510 | New Haven | Connecticut |
| Holden Comprehensive Cancer Center | 52242 | Iowa City | Iowa |
| University of Kansas Cancer Center | 66205 | Westwood | Kansas |
| Saint Elizabeth Medical Center Edgewood | 41017 | Edgewood | Kentucky |
| Dana Farber/Harvard Cancer Center | 02215 | Boston | Massachusetts |
| Metro Minnesota Community Oncology Research Consortium (MMCORC) | 55426 | Saint Louis Park | Minnesota |
| Oncology Hematology West PC dba Nebraska Cancer Specialists | 68130 | Omaha | Nebraska |
| NYU Langone Medical Center | 10016 | New York | New York |
| University of North Carolina at Chapel Hill | 27599 | Chapel Hill | North Carolina |
| Rhode Island Hospital | 02903 | Providence | Rhode Island |
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