Study on Combination Therapy for Esophageal, Gastric, or Gastro-esophageal Junction Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
ClinicalTrials ID:NCT06251973
This clinical trial is testing a combination of five different drugs to see if they can help treat people with esophageal, gastric, or gastro-esophageal junction cancer. The timing of when each drug is given will depend on how the cancer is affecting the participant.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
Participants in this study will receive a combination of five drugs: agenT-797, botensilimab, balstilimab, ramucirumab, and paclitaxel. The study aims to find out if this combination can effectively treat esophageal, gastric, or gastro-esophageal junction cancer. The order and timing of the drugs will be adjusted based on each participant's condition.
Eligibility Criteria
Inclusion Criteria
- Have advanced or metastatic esophageal, gastric, or gastroesophageal junction cancer that cannot be removed by surgery.
- The cancer must have worsened after one previous treatment for metastatic disease, or if untreated, it must have progressed during or shortly after initial treatments.
- Must have a confirmed diagnosis of esophageal, gastric, or gastroesophageal junction adenocarcinoma through lab tests.
- Must have cancer that can be measured or evaluated using standard criteria.
- Must be 18 years or older.
- Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must have adequate organ function, including:
- Neutrophil count of at least 1000/mcL.
- Platelet count of at least 90,000/mcL.
- Hemoglobin level of at least 8 g/dL.
- Serum creatinine level no more than 1.5 times the upper limit of normal.
- Liver function tests within specified limits, except for certain conditions like Gilbert's disease.
- Albumin level of at least 3 mg/dL.
Exclusion Criteria
- Have previously received ramucirumab.
- Have received paclitaxel or docetaxel-based therapy within 6 months before joining the study.
- Have had severe immune-related side effects from certain cancer therapies.
- Have an immune deficiency or are taking immune-suppressing medications, except for specific replacement therapies.
- Have a history of gastrointestinal perforation or fistulae.
- Have active tuberculosis.
- Have active cancer spread to the brain or spinal cord.
- Have a history of lung inflammation not caused by infection.
- Have nerve damage affecting daily activities.
- Have HIV or active hepatitis B or C infections.
- Have received a live vaccine within 30 days before starting the study.
- Have psychiatric or substance abuse issues that would interfere with the study.
- Are pregnant, breastfeeding, or planning to have children during the study and for 5 months after.
- Are unwilling to provide informed consent or unable to follow the study requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | 07920 | Basking Ridge | New Jersey |
| Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | 07748 | Middletown | New Jersey |
| Memorial Sloan Kettering Bergen (Limited Protocol Activities) | 07645 | Montvale | New Jersey |
| Memorial Sloan Kettering Suffolk-Commack (Limited protocol activities) | 11725 | Commack | New York |
| Memorial Sloan Kettering Westchester (Limited Protocol Activities) | 10604 | Harrison | New York |
| Memorial Sloan Kettering Cancer Center (All Protocol Activities) | 10065 | New York | New York |
| Memorial Sloan Kettering Nassau (Limited Protocol Activities) | 11553 | Uniondale | New York |
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