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)

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

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

230 Participants
are divided into 5 treatment groups

Locations

59
Brazil
Liga Norte Riograndense Contra o Câncer ( Site 4303)59062-000, NatalRio Grande do Norte, Brazil
Hospital Nossa Senhora da Conceição ( Site 4301)91350-200, Porto AlegreRio Grande do Sul, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)01246-000, São Paulo Brazil
Chile
Centro de Oncología de Precisión-Oncology ( Site 4404)7560908, SantiagoRegion M. de Santiago, Chile

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor