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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)

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllMerck Sharp & Dohme LLC
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC) * Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy * Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice * 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 Criteria: * 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 history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * 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 * Participants with human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * History of allogenic tissue/solid organ transplant * Clinically significant cardiovascular disease within 12 months from first dose of study intervention * Has risk for significant gastrointestinal (GI) bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization
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What it tests

  • Paclitaxel
  • Irinotecan
  • Pembrolizumab
  • MK-4830
  • Lenvatinib
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Where

58 sites
University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)
Tucson, United States
UCLA Hematology/Oncology - Santa Monica ( Site 4905)
Los Angeles, United States
Hematology-Oncology Associates of Central NY, P.C. ( Site 4925)
East Syracuse, United States
Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907)
New York, United States
UPMC Hillman Cancer Center-UPMC ( Site 4904)
Pittsburgh, United States
Liga Norte Riograndense Contra o Câncer ( Site 4303)
Natal, Brazil
Hospital Nossa Senhora da Conceição ( Site 4301)
Porto Alegre, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)
São Paulo, Brazil

…and 50 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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