Study on Investigational Treatments With or Without Pembrolizumab for Advanced Esophageal Cancer After Previous PD-1/PD-L1 Therapy
Sponsor: Merck Sharp & Dohme LLC
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.
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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).
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