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)

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

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

MK-4830: 800 mg IV infusion, administered Q3W up to 35 infusions.

Lenvatinib: 20 mg oral administration every day.

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

Antihistamine: Administered per product label.

H2 Receptor Antagonist: Administered per product label.

Acetaminophen (or equivalent): Administered per product label.

Dexamethasone (or equivalent): Administered per product label.

Steroid Mouthwash (dexamethasone or equivalent): Administered per product label.

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.

Study 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

Primary outcome measure(s)

• Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) During Safety Lead-in Phase — Up to approximately 3 weeks
  A DLT is defined as any drug-related AE according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.
• Number of Participants Who Experienced an Adverse Event (AE) During Safety Lead-in Phase — Up to approximately 3 weeks
  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
• Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase — Up to approximately 3 weeks
  An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
• Objective Response Rate (ORR) — Up to approximately 48 months
  ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

Trial sites (58)

+ 18 more sites — see the full list on the official registry below.

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