A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT05342636
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — BIOLOGICAL
    200 mg administered via intravenous (IV) infusion every 3 weeks (Q3W)
  • Coformulation favezelimab/pembrolizumab — BIOLOGICAL
    800 mg favezelimab + 200 mg pembrolizumab administered via IV infusion on day 1 and then Q3W
  • MK-4830 — BIOLOGICAL
    800 mg administered via IV infusion Q3W
  • Lenvatinib — DRUG
    20 mg administered via oral capsules each day
  • Irinotecan — DRUG
    180 mg/m\^2 administered via IV infusion on day 1 of every 14-day cycle.
  • Paclitaxel — DRUG
    80-100 mg/m\^2 administered via IV infusion on Days 1, 8 and 15 of every 28 day cycle

Study Details

This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previously exposed to programmed cell death 1 protein (PD-1)/ programmed cell death ligand 1 (PD-L1) based treatment. With protocol amendment 5 (effective: 17-November-2023), enrollment in study arms "Pembrolizumab plus MK-4830 plus Chemotherapy" and "Pembrolizumab plus MK-4830 plus lenvatinib" is discontinued.

Key Dates

Start date
Jul 27, 2022
Status verified
Dec 2025
Primary completion
Dec 5, 2025
Completion
Dec 5, 2025

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab plus chemotherapy
    Participants will receive pembrolizumab intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Coformulation Favezelimab/Pembrolizumab plus Chemotherapy
    Participants will receive coformulation of favezelimab/pembrolizumab administered intravenously plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Pembrolizumab plus MK-4830 plus Chemotherapy
    Participants will receive pembrolizumab intravenously plus MK-4830 plus chemotherapy (investigator's choice of irinotecan or paclitaxel) at specified doses on specified days for a total treatment duration of up to approximately 2 years.
  • Experimental: Pembrolizumab plus MK-4830 plus lenvatinib
    Participants will receive pembrolizumab intravenously plus MK-4830 plus lenvatinib orally at specified doses on specified days for a total treatment duration of up to approximately 2 years.

Primary Outcome Measure

Number of Participants Experiencing a Dose-limiting Toxicity (DLT) During Safety Lead-in Phase [ Time Frame: Up to approximately 3 weeks ]

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