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Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
NCT06780111 · View on ClinicalTrials.gov ↗
Study Summary
Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts. Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. Researchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL I-DXd
- DRUG Leucovorin
- DRUG Levoleucovorin
- DRUG 5-Fluorouracil (5-FU)
Study Locations (20)
Region M. de Santiago
- FALP ( Site 1400) — Santiago
- Centro de Oncología de Precisión ( Site 1402) — Santiago
- Clínica UC San Carlos de Apoquindo ( Site 1403) — Santiago
- Bradfordhill ( Site 1401) — Santiago
Other
- Bradford Hill Norte ( Site 1405) — Antofagasta
- Pitie Salpetriere University Hospital ( Site 9102) — Paris
- Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1807) — Hamburg
Pennsylvania
- UPMC Hillman Cancer Center ( Site 1904) — Pittsburgh
Rio Grande do Norte
- Liga Norte Riograndense Contra o Cancer ( Site 1301) — Natal
Rio Grande do Sul
- Hospital Nossa Senhora da Conceicao ( Site 1300) — Porto Alegre
Los Lagos Region
- Clínica Puerto Montt ( Site 1406) — Port Montt
Anhui
- The Second Affiliated Hospital of Anhui Medical University ( Site 9511) — Hefei
Beijing Municipality
- Beijing Cancer Hospital ( Site 9500) — Beijing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 298 participants |
| Start Date | 2025-07-30 |
| Est. Completion | 2032-01-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06780111
The ClinicalTrials.gov registry entry for NCT06780111 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 298 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Esophageal Squamous Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06780111 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Region M. de Santiago, Other, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06780111 about?
NCT06780111 is a clinical study titled "Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)". Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unre...
What is the current status of trial NCT06780111?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 298 participants. The study started on 2025-07-30. Estimated completion is 2032-01-04.
What conditions does trial NCT06780111 study?
This clinical trial studies the following conditions: Esophageal Squamous Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06780111?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), I-DXd (BIOLOGICAL), Leucovorin (DRUG), Levoleucovorin (DRUG), 5-Fluorouracil (5-FU) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06780111?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06780111 being conducted?
This trial has 20 study locations across Pennsylvania, Rio Grande do Norte, Rio Grande do Sul, Los Lagos Region, Region M. de Santiago. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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