[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06445972":3,"trial-entities:NCT06445972":646,"trial-summary:NCT06445972":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":32,"interventions":35,"primary_outcomes":69,"secondary_outcomes":84,"sex":105,"minimum_age":106,"maximum_age":107,"healthy_volunteers":15,"eligibility_criteria":108,"std_ages":153,"locations":156,"central_contacts":632,"overall_officials":637,"references":641,"see_also_links":642},"NCT06445972","3475-06D","Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D\u002FKeymaker-U06)","A Phase 1\u002F2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced\u002FMetastatic Gastroesophageal Adenocarcinoma: Substudy 06D","RECRUITING","2030-08-08","2026-09","2026-09-03","2024-08-07","Merck Sharp & Dohme LLC","INDUSTRY",false,"This is a phase 1\u002F2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.","This is a substudy of the master protocol MK-3475-U06 (KEYMAKER-U06).",[19,20,21,22],"Gastroesophageal Junction","Gastroesophageal Adenocarcinoma","Esophageal Neoplasms","Esophageal Cancer",[24,25,26],"Programmed Cell Death 1 (PD1, PD-1)","Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)","Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)","INTERVENTIONAL","TREATMENT",[30,31],"PHASE1","PHASE2",{"count":33,"type":34},210,"ESTIMATED",[36,43,49,57,61],{"type":37,"name":38,"description":39,"armGroupLabels":40},"BIOLOGICAL","Ramucirumab","8 mg\u002Fkg IV Infusion",[41,42],"HER3-DXd + Ramucirumab","Ramucirumab + Paclitaxel",{"type":44,"name":45,"description":46,"armGroupLabels":47},"DRUG","Paclitaxel","80 mg\u002FM\\^2 IV infusion",[42,48],"Sacituzumab Tirumotecan + Paclitaxel",{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Sacituzumab Tirumotecan","3 mg\u002Fkg or 4 mg\u002Fkg IV Infusion",[48],[54,55,56],"MK-2870","SKB264","sac-TMT",{"type":44,"name":58,"description":59,"armGroupLabels":60},"Rescue Medications","Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications for the Sacituzumab Tirumotecan + Paclitaxel arm include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent) and rescue medications for the HER3-DXd + ramucirumab arm include 5-HT3-receptor antagonist, NK-1 receptor antagonist, and corticosteroids.",[41,48],{"type":37,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"HER3-DXd","IV Infusion",[41],[66,67,68],"patritumab deruxtecan","MK-1022","U3-1402",[70,74,78,80],{"measure":71,"description":72,"timeFrame":73},"Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase","DLTs are defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The percentage of participants who experience at least one DLT will be presented.","Up to ~28 days",{"measure":75,"description":76,"timeFrame":77},"Percentage of Particiapants who Experience an Adverse Event (AE) During the Safety Lead-In Phase","An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE will be presented.","Up to ~60 days",{"measure":79,"description":76,"timeFrame":73},"Percentage of Participants who Discontinue Study Intervention Due to an AE During the Safety Lead-In Phase",{"measure":81,"description":82,"timeFrame":83},"Objective Response Rate (ORR)","ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.","Up to ~28 months",[85,89,92,95,97,99,102],{"measure":86,"description":87,"timeFrame":88},"Progression Free Survival (PFS)","PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.","Up to ~50 months",{"measure":90,"description":91,"timeFrame":88},"Duration of Response (DOR)","For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.",{"measure":93,"description":94,"timeFrame":88},"Overall Survival (OS)","OS is defined as the time from the date of randomization to the date of death from any cause. OS will be presented.",{"measure":96,"description":76,"timeFrame":88},"Percentage of Particiapants who Experience an AE During the Efficacy Phase",{"measure":98,"description":76,"timeFrame":88},"Percentage of Participants who Discontinue Study Intervention Due to an AE During the Efficacy Phase",{"measure":100,"description":101,"timeFrame":88},"Incidence of sacituzumab tirumotecan anti-drug antibody (ADA)","In participants treated with sacituzumab tirumotecan the immunogenicity of sacituzumab tirumotecan ADA response will be evaluated with validated immunogenicity assays.",{"measure":103,"description":104,"timeFrame":88},"Incidence of HER3-DXd ADA","In participants treated with HER3-DXd, the immunogenicity of HER3-DXd ADA response will be evaluated with validated immunogenicity assays.","ALL","18 Years",null,{"inclusion":109,"exclusion":121,"raw_text":152},[110,111,112,113,114,115,116,117,118,119,120],"Has histologically and\u002For cytologically confirmed diagnosis of previously treated, second line (2L) (received first line (1L) treatment) gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma","Has metastatic disease or locally advanced, unresectable disease","Has experienced documented objective radiographic or clinical disease progression during or after 1L therapy containing any platinum\u002Ffluoropyrimidine doublet with or without immunotherapy","Tumor tissue must be confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines","Can provide a core\u002Fexcisional biopsy of a tumor lesion not previously irradiated (collected from a biopsy performed after the most recent systemic anticancer therapy regimen)","AEs due to previous anticancer therapies must be ≤Grade 1 or baseline (except alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone replacement are acceptable","Has Eastern Cooperative Oncology Group performance status of 0 or 1","Has a life expectancy of at least 3 months","Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation\u002Frandomization","Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening","Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy",[122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151],"Has squamous cell or undifferentiated gastroesophageal cancer","Has experienced weight loss \\>20% over 3 months before the first dose of study intervention","Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays 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 allocation\u002Frandomization","Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea)","Has uncontrolled, significant cardiovascular disease or cerebrovascular disease","Has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to allocation\u002Frandomization","Has uncontrolled arterial hypertension ≥150\u002F≥90 mm mercury (Hg)","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 allocation\u002Frandomization, or central venous access device placement within 7 days prior to allocation\u002Frandomization or planned major surgery following initiation of study treatment","Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents","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 allocation\u002Frandomization","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\u002For fistulae within 6 months prior to allocation\u002Frandomization","HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease","Has received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)- or HER3-targeted agent, topoisomerase 1 inhibitor-based ADC and\u002For 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","Has received prior systemic anticancer therapy within 4 weeks 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","Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded","Has known active central nervous system metastases and\u002For carcinomatous meningitis","Has an active infection requiring systemic therapy","Has concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV deoxyribonucleic acid) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid) infection","History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease, or where suspected ILD or pneumonitis cannot be ruled out by imaging at screening","Has severe hypersensitivity (Grade ≥3) to MK-2870, or HER3-DXd, any of their excipients, and\u002For to another biologic therapy","Has not adequately recovered from major surgery or have ongoing surgical complications","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically and\u002For cytologically confirmed diagnosis of previously treated, second line (2L) (received first line (1L) treatment) gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma\n* Has metastatic disease or locally advanced, unresectable disease\n* Has experienced documented objective radiographic or clinical disease progression during or after 1L therapy containing any platinum\u002Ffluoropyrimidine doublet with or without immunotherapy\n* Tumor tissue must be confirmed as negative for HER2 expression (IHC 0\u002F1+ or IHC2+\u002Fin situ hybridization negative) as classified by American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO-CAP) guidelines\n* Can provide a core\u002Fexcisional biopsy of a tumor lesion not previously irradiated (collected from a biopsy performed after the most recent systemic anticancer therapy regimen)\n* AEs due to previous anticancer therapies must be ≤Grade 1 or baseline (except alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone replacement are acceptable\n* Has Eastern Cooperative Oncology Group performance status of 0 or 1\n* Has a life expectancy of at least 3 months\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation\u002Frandomization\n* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening\n* Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Has squamous cell or undifferentiated gastroesophageal cancer\n* Has experienced weight loss \\>20% over 3 months before the first dose of study intervention\n* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and\u002For blepharitis, or severe corneal disease that prevents\u002Fdelays corneal healing\n* Has Grade ≥2 peripheral neuropathy\n* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease\n* Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to allocation\u002Frandomization\n* Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea)\n* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease\n* Has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to allocation\u002Frandomization\n* Has uncontrolled arterial hypertension ≥150\u002F≥90 mm mercury (Hg)\n* Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment\n* Has undergone major surgery within 28 days prior to allocation\u002Frandomization, or central venous access device placement within 7 days prior to allocation\u002Frandomization or planned major surgery following initiation of study treatment\n* Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents\n* Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents\n* Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to allocation\u002Frandomization\n* Has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry\n* Has history of GI perforation and\u002For fistulae within 6 months prior to allocation\u002Frandomization\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)- or HER3-targeted agent, topoisomerase 1 inhibitor-based ADC and\u002For 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\n* Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention\n* Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed\n* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration\n* Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis\n* Has an active infection requiring systemic therapy\n* Has concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV deoxyribonucleic acid) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid) infection\n* History of (noninfectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease, or where suspected ILD or pneumonitis cannot be ruled out by imaging at screening\n* Has severe hypersensitivity (Grade ≥3) to MK-2870, or HER3-DXd, any of their excipients, and\u002For to another biologic therapy\n* Has not adequately recovered from major surgery or have ongoing surgical complications",[154,155],"ADULT","OLDER_ADULT",[157,171,182,191,202,213,219,230,241,253,264,274,281,293,304,315,322,329,336,346,358,369,379,390,401,412,423,434,446,457,468,480,488,499,511,522,533,542,553,564,571,583,594,605,615,625],{"facility":158,"status":8,"city":159,"state":160,"zip":161,"country":162,"contacts":163,"geoPoint":168},"University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927)","Tucson","Arizona","85719","United States",[164],{"name":165,"role":166,"phone":167},"Study Coordinator","CONTACT","520-621-2449",{"lat":169,"lon":170},32.22174,-110.92648,{"facility":172,"status":8,"city":173,"state":174,"zip":175,"country":162,"contacts":176,"geoPoint":179},"UCLA Hematology\u002FOncology - Santa Monica ( Site 8905)","Los Angeles","California","90404",[177],{"name":165,"role":166,"phone":178},"310-570-1453",{"lat":180,"lon":181},34.05223,-118.24368,{"facility":183,"status":184,"city":185,"state":186,"zip":187,"country":162,"geoPoint":188},"Norton Cancer Institute - Downtown ( Site 8900)","COMPLETED","Louisville","Kentucky","40202",{"lat":189,"lon":190},38.25424,-85.75941,{"facility":192,"status":8,"city":193,"state":194,"zip":195,"country":162,"contacts":196,"geoPoint":199},"The Cancer and Hematology Centers ( Site 8912)","Grand Rapids","Michigan","49503",[197],{"name":165,"role":166,"phone":198},"616-975-3065",{"lat":200,"lon":201},42.96336,-85.66809,{"facility":203,"status":8,"city":204,"state":205,"zip":206,"country":162,"contacts":207,"geoPoint":210},"Hematology-Oncology Associates of Central NY, P.C. ( Site 8925)","East Syracuse","New York","13057",[208],{"name":165,"role":166,"phone":209},"315-472-7504",{"lat":211,"lon":212},43.06534,-76.07853,{"facility":214,"status":184,"city":205,"state":205,"zip":215,"country":162,"geoPoint":216},"Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907)","10032",{"lat":217,"lon":218},40.71427,-74.00597,{"facility":220,"status":8,"city":221,"state":222,"zip":223,"country":162,"contacts":224,"geoPoint":227},"UPMC Hillman Cancer Center-UPMC ( Site 8904)","Pittsburgh","Pennsylvania","15232",[225],{"name":165,"role":166,"phone":226},"816-898-9413",{"lat":228,"lon":229},40.44062,-79.99589,{"facility":231,"status":8,"city":232,"state":233,"zip":234,"country":162,"contacts":235,"geoPoint":238},"University of Texas MD Anderson Cancer Center ( Site 8920)","Houston","Texas","77030",[236],{"name":165,"role":166,"phone":237},"833-589-0868",{"lat":239,"lon":240},29.76328,-95.36327,{"facility":242,"status":8,"city":243,"state":244,"zip":245,"country":246,"contacts":247,"geoPoint":250},"Liga Norte Riograndense Contra o Câncer ( Site 8303)","Natal","Rio Grande do Norte","59062-000","Brazil",[248],{"name":165,"role":166,"phone":249},"+558440095595",{"lat":251,"lon":252},-5.795,-35.20944,{"facility":254,"status":8,"city":255,"state":256,"zip":257,"country":246,"contacts":258,"geoPoint":261},"Hospital Nossa Senhora da Conceição ( Site 8301)","Porto Alegre","Rio Grande do Sul","91350-200",[259],{"name":165,"role":166,"phone":260},"+5551993590437",{"lat":262,"lon":263},-30.03283,-51.23019,{"facility":265,"status":8,"city":266,"state":266,"zip":267,"country":246,"contacts":268,"geoPoint":271},"IBCC - 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