Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents 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
Sponsor: Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Time frame: Up to approximately 28 days
Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to approximately 28 days
Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE
Time frame: Up to approximately 28 days
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Time frame: Up to approximately 28 months
Secondary Endpoints
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Overall Survival (OS)
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gastroesophageal adenocarcinoma * Is not expected to require tumor resection during the treatment course * Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines * Core/excisional biopsy of a tumor lesion not previously irradiated has been provided * Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline * Participants with endocrine-related AEs who are adequately treated with hormone replacement therapy are eligible * Has adequate organ function * Has measurable disease per Response Evaluation Criteria in Solid Tumors Ver…
Read full criteria on CT.gov →✦ Analyst Commentary
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