Trial Type
Follow-Up Treatment (Metastatic Disease)
Description for experts
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study toevaluate the safety and efficacy of investigational agents with or without pembrolizumaband/or chemotherapy, for the treatment of participants with second line (2L) esophagealsquamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 basedtreatment.
Description for laymen
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study toevaluate the safety and efficacy of investigational agents with or without pembrolizumaband/or chemotherapy, for the treatment of participants with second line (2L) esophagealsquamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 basedtreatment.
JSON Data
{
"short_title": "MK-3475_06B",
"data_mode": "900",
"data_mode_number": "000002333",
"official_title": "A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B",
"accrual_state": "running",
"therapeutic_value": "therapeutic",
"therapieansatz_value": "palliativ",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "second",
"ctgov_number": "NCT05319730",
"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": "Dies ist eine multizentrische, randomisierte, offene Phase-1/2-Studie zur Bewertung der Sicherheit und Wirksamkeit von Pr\u00fcfpr\u00e4paraten mit oder ohne Pembrolizumab und/oder Chemotherapie f\u00fcr die Behandlung von Patienten mit Zweitlinien-\u00d6sophaguszellkarzinom (ESCC), die zuvor eine PD-1/PD-L1-basierte Behandlung erhalten haben.",
"description_laie_en": "This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study toevaluate the safety and efficacy of investigational agents with or without pembrolizumaband/or chemotherapy, for the treatment of participants with second line (2L) esophagealsquamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 basedtreatment.",
"description_expert_de": "Dies ist eine multizentrische, randomisierte, offene Phase-1/2-Studie zur Bewertung der Sicherheit und Wirksamkeit von Pr\u00fcfpr\u00e4paraten mit oder ohne Pembrolizumab und/oder Chemotherapie f\u00fcr die Behandlung von Patienten mit Zweitlinien-\u00d6sophaguszellkarzinom (ESCC), die zuvor eine PD-1/PD-L1-basierte Behandlung erhalten haben.",
"description_expert_en": "This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study toevaluate the safety and efficacy of investigational agents with or without pembrolizumaband/or chemotherapy, for the treatment of participants with second line (2L) esophagealsquamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 basedtreatment.",
"rechtsgrundlage_value": "AMG",
"phase_amg_value": "I_II",
"main_cat_id": 2,
"sub_cat_id": 5
}
