A Study to Evaluate Investigational Agents With or Without Pembrolizumab (MK-3475) in Participants With Advanced Esophageal Cancer Previously Exposed to Programmed Cell Death 1 Protein (PD-1)/ Programmed Cell Death Ligand 1 (PD-L1) Treatment (MK-3475-06B)
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
Merck Sharp & Dohme LLC
230 participants
May 16, 2023
INTERVENTIONAL
Conditions
Summary
This is a Phase 1/2, multicenter, randomized, open-label umbrella platform study to evaluate the safety and efficacy of investigational agents with or without pembrolizumab and/or chemotherapy, for the treatment of participants with second line (2L) esophageal squamous cell carcinoma (ESCC) who have previously been exposed to PD-1/PD-L1 based treatment.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
80-100 mg/m\^2 IV infusion, administered on days 1, 8, and 15 of every 28-day cycle.
180 mg/m\^2 IV infusion, administered on day 1 of every 14-day cycle.
200 mg IV infusion, administered every Q3W up to 35 infusions.
800 mg IV infusion, administered Q3W up to 35 infusions.
20 mg oral administration every day.
4 mg/kg or 5 mg/kg IV infusion on Days 1, 15, and 29 of each 42-day cycle.
Administered per product label.
Administered per product label.
Administered per product label.
Administered per product label.
Administered per product label.
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or ointment may be given as a supportive care for Ocular Surface Toxicity.
Locations(57)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05319730