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
  Antihistamine

  Administered per product label.

• Drug
  H2 Receptor Antagonist

  Administered per product label.

• Drug
  Acetaminophen (or equivalent)

  Administered per product label.

• Drug
  Dexamethasone (or equivalent)

  Administered per product label.

• Drug
  Steroid Mouthwash (dexamethasone or equivalent)

  Administered per product label.

• Drug
  Supportive care measures

  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.

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