Study on Investigational Treatments With or Without Pembrolizumab for Advanced Esophageal Cancer After Previous PD-1/PD-L1 Therapy

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT05319730

This clinical trial is testing new treatments, with or without the drug pembrolizumab, for patients with advanced esophageal cancer who have already received PD-1/PD-L1 therapy. The study aims to evaluate the safety and effectiveness of these treatments.

Patient Parameters

Program Overview

This study is a Phase 1/2 trial conducted at multiple centers to test the safety and effectiveness of new treatments, with or without pembrolizumab and/or chemotherapy, for patients with advanced esophageal squamous cell carcinoma (ESCC). These patients have previously been treated with PD-1/PD-L1 therapies and are now receiving a second line of treatment.

Description

The study is based on the master protocol MK-3475-U06. As of the latest update, the treatment groups involving Pembrolizumab with MK-4830 and either Paclitaxel/Irinotecan or Lenvatinib are no longer accepting new participants.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced esophageal squamous cell carcinoma (ESCC) that cannot be surgically removed.
  • Experienced disease progression after one prior standard treatment that included a platinum-based drug and PD-1/PD-L1 therapy.
  • Have a tumor sample available for analysis.
  • Blood pressure must be well-controlled, with or without medication.
  • Any side effects from previous cancer treatments must have improved to a mild level or returned to baseline. Patients with hormone-treated endocrine issues or mild nerve damage are eligible.

Exclusion Criteria

  • Cancer has spread to nearby organs like the aorta or trachea.
  • Significant weight loss of more than 10% in the last two months.
  • Severe eye conditions that affect healing.
  • Active inflammatory bowel disease requiring immunosuppressive medication.
  • Participation in another study or use of an investigational device within the last four weeks.
  • Immune system deficiencies or use of immunosuppressive therapy within the last week.
  • Another progressing cancer or one treated in the last three years, except for certain skin cancers or carcinoma in situ.
  • Active cancer spread to the brain or spinal fluid.
  • Active autoimmune disease needing treatment in the last two years.
  • HIV with a history of certain related diseases.
  • Active hepatitis B and C infections.
  • History of organ transplant.
  • Serious heart disease within the last year.
  • Conditions affecting the absorption of lenvatinib (not applicable to current study groups).
  • Risk of significant gastrointestinal bleeding or recent serious bleeding events (not applicable to current study groups).

Locations

FACILITYZIPCITYSTATE
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)85719TucsonArizona
Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)13057East SyracuseNew York
UPMC Hillman Cancer Center-UPMC ( Site 4904)15232PittsburghPennsylvania

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