Phase 2 Oesophageal Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with stomach (gastric) adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma, confirmed by lab testing of tissue or cells, and who have already received one prior treatment (first-line therapy)
• People whose cancer has spread to other parts of the body or has grown in a way that cannot be surgically removed
• People whose cancer continued to grow or got worse during or after a first treatment that included a standard combination of platinum and fluoropyrimidine chemotherapy drugs, with or without immunotherapy
• People whose tumor has been tested and found to be HER2-negative, as classified under standard medical guidelines
• People who are able to provide a fresh tissue sample (core or excisional biopsy) from a tumor area that has not previously been treated with radiation, taken after the most recent cancer treatment
• People whose side effects from previous cancer treatments have mostly resolved to mild or baseline levels (hair loss and skin colour changes are exceptions; hormone-related side effects that are managed with replacement therapy are also acceptable)
• People with a physical functioning score of 0 or 1 on the ECOG scale, meaning they are either fully active or have only minor limitations in strenuous activity (confirm with trial site)
• People with a life expectancy of at least 3 months
• People who are hepatitis B surface antigen positive, provided they have been on hepatitis B antiviral treatment for at least 4 weeks and have an undetectable hepatitis B virus level before being assigned to a treatment group
• People with a history of hepatitis C infection, provided the hepatitis C virus level is undetectable at screening
• People living with HIV, provided their HIV is well controlled on antiviral medication

Who may not be able to join:

• People whose gastroesophageal cancer is of the squamous cell or undifferentiated type
• People who have lost more than 20% of their body weight in the 3 months before starting the study treatment
• People with a history of severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis (eyelid inflammation), or severe corneal (eye surface) disease that prevents or delays healing
• People with moderate or severe peripheral neuropathy (nerve damage causing numbness, tingling, or pain, graded at level 2 or higher)
• People with active inflammatory bowel disease requiring immune-suppressing medication, or a prior history of inflammatory bowel disease
• People with a serious or non-healing wound, peptic ulcer, or bone fracture in the 28 days before being assigned to a treatment group
• People with a bowel obstruction, inflammatory bowel condition, or who have had a large portion of the intestine surgically removed and experience chronic diarrhoea as a result
• People with uncontrolled or significant heart or blood vessel disease, or uncontrolled cerebrovascular (brain blood vessel) disease
• People who have had a serious arterial blood clot event — such as a heart attack, unstable angina, stroke, or mini-stroke — within the 6 months before being assigned to a treatment group
• People with uncontrolled high blood pressure at or above 150/90 mmHg
• People who have had a build-up of fluid around the lungs, abdomen, or heart requiring drainage or diuretic (fluid-reducing) medication within 2 weeks before enrolment
• People who have had major surgery within 28 days before being assigned to a treatment group, or a central venous access device placed within 7 days before that point, or who have major surgery planned after starting the study treatment
• People currently receiving blood-thinning (anticoagulation) therapy with warfarin, low-molecular weight heparin, or similar medications
• People receiving ongoing treatment with anti-inflammatory drugs (such as ibuprofen or aspirin) or other antiplatelet (blood-clot-preventing) medicines
• People who have had a deep vein thrombosis (blood clot in a vein), pulmonary embolism (blood clot in the lungs), or other significant blood clot event in the 3 months before being assigned to a treatment group
• People with significant bleeding disorders, vasculitis (blood vessel inflammation), or a significant bleeding episode from the digestive tract within 3 months before joining the study
• People with a history of a hole (perforation) or abnormal passageway (fistula) in the digestive tract within 6 months before being assigned to a treatment group
• People living with HIV who have a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• People who have previously been treated with certain targeted therapies, including agents targeting TROP2 or HER3, topoisomerase 1 inhibitor-based antibody-drug conjugates or chemotherapy, or any systemic therapy targeting VEGF or VEGFR signalling pathways (confirm with trial site for specific drug names)
• People who have received systemic cancer treatment within 4 weeks before the first dose of the study treatment
• People who have received radiation therapy within 2 weeks before starting the study treatment, or who still have side effects from radiation that require steroid medication
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of the study treatment (non-live/killed vaccines are permitted)
• People who have taken part in another investigational (experimental) drug or device study within 4 weeks before starting the study treatment
• People who have another cancer that is currently active or has required treatment within the past 3 years (certain skin cancers or non-invasive cancers that have been treated with curative intent may be exceptions — confirm with trial site)
• People with active cancer spread to the brain or the membranes surrounding the brain and spinal cord
• People with an active infection currently requiring systemic (whole-body) treatment
• People with both active hepatitis B and active hepatitis C infections at the same time
• People with a history of non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment, or who currently have this condition, or where this condition cannot be ruled out by imaging at screening
• People who have had a severe allergic reaction (grade 3 or higher) to the study drugs MK-2870 or HER3-DXd, any of their ingredients, or to another biological therapy
• People who have not fully recovered from a major surgery or who have ongoing surgical complications

Important: Always verify eligibility with the trial site directly before applying.