Substudy 06D: Combination Therapies in 2L Advanced Gastroesophageal Adenocarcinoma
- Conditions
- Gastroesophageal cancerMedDRA version: 21.0Level: LLTClassification code: 10056267Term: Gastroesophageal cancer Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-509306-29-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 94
Has histologically and/or cytologically confirmed diagnosis of previously treated, second line (received first line treatment) gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma, Has Eastern Cooperative Oncology Group performance status of 0 or 1, Has a life expectancy of at least 3 months, Has metastatic disease or locally advanced, unresectable disease, Has experienced documented objective radiographic or clinical disease progression during or after first line therapy containing any platinum/fluoropyrimidine doublet with or without immunotherapy, Has gastroesophageal adenocarcinoma that is not human epidermal growth factor receptor 2 (HER2)/neu positive, Has measurable disease per RECIST 1.1 as determined by the local site investigator/radiology assessment and verified by blinded independent central review (BICR), Has provided an archival tumor tissue sample or most recently obtained core, incisional, or excisional biopsy of a tumor lesion, Participants who have AEs due to previous anticancer therapies must have recovered to =Grade 1 or baseline (except alopecia and vitiligo). Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible, Has adequate organ function, Has urinary protein =1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates proteinuria =2+, then a 24-hour urine must be collected and must demonstrate <1000 mg of protein in 24 hours to allow participation in the study
Has squamous cell or undifferentiated esophageal gastric cancer, Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment, Has undergone major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to randomization or planned major surgery following initiation of study treatment, Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents, Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to randomization, Has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry, Has history of GI perforation and/or fistulae within 6 months prior to randomization, Has history of human immunodeficiency virus infection, Has received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC), topoisomerase 1 inhibitor-based ADC and/or a topoisomerase 1 inhibitor-based chemotherapy, or any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or the vascular endothelial growth factor receptor (VEGFR) signaling pathways, Is currently receiving a strong and/or moderate inducer/inhibitor of Cytochrome P450 3A4 that cannot be discontinued for the duration of the study, Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study drug intervention, Has experienced weight loss >20% over 3 months before the first dose of study intervention, Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids, Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed, Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration, Known additional malignancy that is progressing or has required active treatment within the past 3 years, Known active central nervous system metastases and/or carcinomatous meningitis, Active infection requiring systemic therapy, Has concurrent active Hepatitis B and Hepatitis C virus infection, Severe hypersensitivity (Grade =3) to MK-2870, any of its excipients and/or to another biologic therapy, Has not adequately recovered from major surgery or have ongoing surgical complications, Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing, Has Grade =2 peripheral neuropathy, Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease, Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to randomization, Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn’s disease, ulcerative colitis, or chronic diarrhea, Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, Has uncontrolled arterial hypertension =150/=90 mm mercury (Hg) despite standard medical management
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method