Status:
COMPLETED
A Study of Combination Therapies With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer (MK-3475-06A)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Esophageal Squamous Cell Carcinoma (ESCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 t...
Detailed Description
The master protocol is MK-3475-U06.
Eligibility Criteria
Inclusion
- The main inclusion and exclusion criteria include but are not limited to the following:
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable ESCC
- Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy.
- Has an evaluable baseline tumor sample (newly obtained or archival) for analysis
- Has adequately controlled blood pressure (BP) with or without antihypertensive medications
- Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible
Exclusion
- Direct invasion into adjacent organs such as the aorta or trachea
- Has experienced weight loss \>10% over approximately 2 months prior to first dose of study therapy
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
- Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication
- Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in past 2 years
- History of human immunodeficiency virus (HIV) infection
- History of Hepatitis B or known active Hepatitis C virus infection
- History of allogenic tissue/solid organ transplant
- Clinically significant cardiovascular disease within 12 months from first dose of study intervention
- Participants with known gastrointestinal (GI) malabsorption or any other condition that may affect the absorption of lenvatinib
- Has risk for significant GI bleeding, such as:
- Has had a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization
- Has significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization
Key Trial Info
Start Date :
July 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05342636
Start Date
July 27 2022
End Date
December 5 2025
Last Update
December 17 2025
Active Locations (46)
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1
Liga Norte Riograndense Contra o Câncer ( Site 2303)
Natal, Rio Grande do Norte, Brazil, 59062-000
2
Hospital Nossa Senhora da Conceição ( Site 2301)
Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
3
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 2300)
São Paulo, São Paulo, Brazil, 01246-000
4
FALP-UIDO ( Site 2400)
Santiago, Region M. de Santiago, Chile, 7500921