MK-3475-06C KEYMAKER

This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluatethe safety and tolerability of sacituzumab tirumotecan with pembrolizumab andfluoropyrimidine chemotherapy for the first-line (1L) treatment of participants withlocally advanced unresectable or metastatic human epidermal growth factor receptor 2(HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.This substudy will have two phases: a safety lead-in phase and an efficacy phase. Thesafety lead-in phase will be used to evaluate the safety and tolerability, and toestablish a recommended Phase 2 dose (RP2D) for sacituzumab tirumotecan in combinationwith chemotherapy and immunotherapy. There is no formal hypothesis in this study.

{ "short_title": "MK-3475-06C KEYMAKER", "data_mode": "900", "data_mode_number": "000002390", "official_title": "A Phase 1/2 Open-Label, Umbrella Platform Design Study of MK-2870 With Pembrolizumab (MK-3475) and Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, and Esophageal Adenocarcinoma): Substudy 06C", "accrual_state": "planned", "therapeutic_value": "therapeutic", "therapieansatz_value": "palliativ", "therapieintervention_value": "not_applicable", "therapielinie_value": "first", "ctgov_number": "NCT06469944", "eudract_number": null, "general_contact_email": "oncostudy@ukdd.de", "general_contact_phone": "+49 351-4587666", "hauptpruefer_dd_name": "Prof. Dr. med. Gunnar Folprecht", "description_laie_de": "Es handelt sich um eine multizentrische, offene Phase-1/2-Dachplattformstudie, die die Sicherheit und Vertr\u00e4glichkeit von Sacituzumab-Tirumotecan in Kombination mit Pembrolizumab und einer Fluoropyrimidin-Chemotherapie f\u00fcr die Erstlinienbehandlung (1L) von Teilnehmern mit lokal fortgeschrittenem, inoperablem oder metastasiertem humanem epidermalem Wachstumsfaktor-Rezeptor-2(HER2)-negativem Adenokarzinom des Magens, des gastro\u00f6sophagealen \u00dcbergangs oder der Speiser\u00f6hre untersuchen wird. Diese Teilstudie wird zwei Phasen umfassen: eine Sicherheitsphase und eine Wirksamkeitsphase. Die Sicherheitsphase dient dazu, die Sicherheit und Vertr\u00e4glichkeit zu bewerten und eine empfohlene Phase-2-Dosis (RP2D) f\u00fcr Sacituzumab-Tirumotecan in Kombination mit Chemotherapie und Immuntherapie festzulegen. F\u00fcr diese Studie gibt es keine formale Hypothese.", "description_laie_en": "This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluatethe safety and tolerability of sacituzumab tirumotecan with pembrolizumab andfluoropyrimidine chemotherapy for the first-line (1L) treatment of participants withlocally advanced unresectable or metastatic human epidermal growth factor receptor 2(HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.This substudy will have two phases: a safety lead-in phase and an efficacy phase. Thesafety lead-in phase will be used to evaluate the safety and tolerability, and toestablish a recommended Phase 2 dose (RP2D) for sacituzumab tirumotecan in combinationwith chemotherapy and immunotherapy. There is no formal hypothesis in this study.", "description_expert_de": "Es handelt sich um eine multizentrische, offene Phase-1/2-Dachplattformstudie, die die Sicherheit und Vertr\u00e4glichkeit von Sacituzumab-Tirumotecan in Kombination mit Pembrolizumab und einer Fluoropyrimidin-Chemotherapie f\u00fcr die Erstlinienbehandlung (1L) von Teilnehmern mit lokal fortgeschrittenem, inoperablem oder metastasiertem humanem epidermalem Wachstumsfaktor-Rezeptor-2(HER2)-negativem Adenokarzinom des Magens, des gastro\u00f6sophagealen \u00dcbergangs oder der Speiser\u00f6hre untersuchen wird. Diese Teilstudie wird zwei Phasen umfassen: eine Sicherheitsphase und eine Wirksamkeitsphase. Die Sicherheitsphase dient dazu, die Sicherheit und Vertr\u00e4glichkeit zu bewerten und eine empfohlene Phase-2-Dosis (RP2D) f\u00fcr Sacituzumab-Tirumotecan in Kombination mit Chemotherapie und Immuntherapie festzulegen. F\u00fcr diese Studie gibt es keine formale Hypothese.", "description_expert_en": "This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluatethe safety and tolerability of sacituzumab tirumotecan with pembrolizumab andfluoropyrimidine chemotherapy for the first-line (1L) treatment of participants withlocally advanced unresectable or metastatic human epidermal growth factor receptor 2(HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.This substudy will have two phases: a safety lead-in phase and an efficacy phase. Thesafety lead-in phase will be used to evaluate the safety and tolerability, and toestablish a recommended Phase 2 dose (RP2D) for sacituzumab tirumotecan in combinationwith chemotherapy and immunotherapy. There is no formal hypothesis in this study.", "rechtsgrundlage_value": "AMG", "phase_amg_value": "I_II", "main_cat_id": 2, "sub_cat_id": 5 }