About this trial
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 criteria
Qualifiers
None
Disqualifiers
Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)
Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy
Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice
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 or participants who have ≤Grade 2 neuropathy are eligible
Trial design
Treatments tested in this trial
- Paclitaxel
- Irinotecan
- Pembrolizumab
- MK-4830
- Lenvatinib
- Sacituzumab tirumotecan
- Antihistamine
- H2 Receptor Antagonist
- Acetaminophen (or equivalent)
- Dexamethasone (or equivalent)
- Steroid Mouthwash (dexamethasone or equivalent)
- Supportive care measures
Treatment groups
Locations
59Sponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor