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NCT06780111 · ClinicalTrials.gov registry record · Phase 1
Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
A Phase 1 study of Esophageal Squamous Cell Carcinoma, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 298
- Enrollment target
- 20
- Study locations
NCT06780111: Recruiting Phase 1 study of Esophageal Squamous Cell Carcinoma, sponsored by Merck Sharp & Dohme.
NCT06780111 is a Phase 1 study of Esophageal Squamous Cell Carcinoma that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 298 participants, below the 367-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (19% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06780111, a Phase 1 study of Esophageal Squamous Cell Carcinoma, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 298 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Percentage of participants experiencing toxicities that are possibly, probably, or definitely related to study intervention; that meet pre-defined severity criteria; and result in a change in the given dose.
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 |
What NCT06780111 shows while recruiting
NCT06780111 is an interventional study that assigns participants to a tested intervention. The registered 298 participants enrollment target is mid-sized for trials with a published cap, below the 367-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (19% lower).
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.
NCT06780111 names 20 study sites across 15 states, led by Region M. de Santiago, Other, Pennsylvania.
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.
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).
Who is sponsoring clinical trial NCT06780111?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06780111's enrollment target sits among peer trials
298 10th of 22 higher than 13 of 22 other Esophageal Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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