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

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.

Description

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Paclitaxel

  80-100 mg/m\^2 IV infusion, administered on days 1, 8, and 15 of every 28-day cycle.

• Drug
  Irinotecan

  180 mg/m\^2 IV infusion, administered on day 1 of every 14-day cycle.

• Biological
  Pembrolizumab

  200 mg IV infusion, administered every Q3W up to 35 infusions.

• Biological
  MK-4830

  800 mg IV infusion, administered Q3W up to 35 infusions.

• Drug
  Lenvatinib

  20 mg oral administration every day.

• Biological
  Sacituzumab tirumotecan

  4 mg/kg or 5 mg/kg IV infusion on Days 1, 15, and 29 of each 42-day cycle.

• Drug

Locations (57)