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)

Conditions

• Esophageal Squamous Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Paclitaxel — DRUG
  80-100 mg/m\^2 IV infusion, administered on days 1, 8, and 15 of every 28-day cycle.
• Irinotecan — DRUG
  180 mg/m\^2 IV infusion, administered on day 1 of every 14-day cycle.
• Pembrolizumab — BIOLOGICAL
  200 mg IV infusion, administered every Q3W up to 35 infusions.
• MK-4830 — BIOLOGICAL
  800 mg IV infusion, administered Q3W up to 35 infusions.
• Lenvatinib — DRUG
  20 mg oral administration every day.
• Sacituzumab tirumotecan — BIOLOGICAL
  4 mg/kg or 5 mg/kg IV infusion on Days 1, 15, and 29 of each 42-day cycle.
• Antihistamine — DRUG
  Administered per product label.
• H2 Receptor Antagonist — DRUG
  Administered per product label.
• Acetaminophen (or equivalent) — DRUG
  Administered per product label.
• Dexamethasone (or equivalent) — DRUG
  Administered per product label.
• Steroid Mouthwash (dexamethasone or equivalent) — DRUG
  Administered per product label.
• Supportive care measures — DRUG
  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 Details

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.

Key Dates

Start date

May 16, 2023

Status verified

May 2026

Primary completion

Jun 11, 2027

Completion

Apr 10, 2029

Study Design

Enrollment

230 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Paclitaxel or irinotecan
  Participants receive paclitaxel 80-100 mg/m\^2 intravenously (IV) on Days 1, 8, and 15 every 28-day cycle until progressive disease (PD) or discontinuation, or irinotecan 180 mg/m\^2 IV on day 1 of every 14-day cycle until PD or discontinuation.
• Experimental: Pembrolizumab + MK-4830 + paclitaxel or irinotecan
  Participants receive pembrolizumab 200 mg IV once every 3 weeks (Q3W) for up to 35 cycles (cycle=21 days) or until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + paclitaxel 80-100 mg/m\^2 IV on Days 1, 8, and 15 every 28-day cycle until PD or discontinuation or irinotecan 180 mg/m\^2 180 mg/m\^2 on day 1 every 14-day cycle until PD or discontinuation.
• Experimental: Pembrolizumab + MK-4830 + lenvatinib
  Participants receive pembrolizumab 200 mg IV Q3W up to 35 cycles (cycle=21 days) until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + lenvatinib 20 mg oral administration every day until PD or discontinuation.
• Experimental: Sacituzumab tirumotecan 4 mg/kg
  Participants will receive 4 mg/kg of sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 of each 42-day cycle until discontinuation.
• Experimental: Sacituzumab tirumotecan 5 mg/kg
  Participants will receive 5 mg/kg of sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 of each 42-day cycle until discontinuation.

Primary Outcome Measure

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) During Safety Lead-in Phase [ Time Frame: Up to approximately 3 weeks ]

Central Contacts

• Toll Free Number
  1-888-577-8839
  [email protected]

Locations (5)

Find similar trials in Tucson, AZ

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