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NCT06469944 · ClinicalTrials.gov registry record · Phase 1
Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)
A Phase 1 study of Esophageal Cancer and Esophageal Neoplasms, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT06469944 is a Phase 1 study of Esophageal Cancer and Esophageal Neoplasms that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 160 participants, below the 498-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT06469944, a Phase 1 study of Esophageal Cancer and Esophageal Neoplasms, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma. This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Capecitabine
- DRUG Leucovorin
- DRUG Levoleucovorin
- BIOLOGICAL Sacituzumab Tirumotecan (sac-TMT)
Study Locations (20)
Region M. de Santiago
- FALP-UIDO ( Site 6400) - Santiago
- Centro de Oncología de Precisión-Oncology ( Site 6404) - Santiago
- Clínica UC San Carlos de Apoquindo ( Site 6405) - Santiago
- Bradfordhill-Clinical Area ( Site 6401) - Santiago
New York
- Hematology-Oncology Associates of Central NY, P.C. ( Site 6925) - East Syracuse
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907) - New York
Other
- IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304) - São Paulo
- Bradford Hill Norte ( Site 6407) - Antofagasta
Arizona
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927) - Tucson
California
- UCLA Hematology/Oncology - Santa Monica ( Site 6905) - Los Angeles
Kentucky
- Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900) - Louisville
Michigan
- The Cancer and Hematology Centers ( Site 6912) - Grand Rapids
Pennsylvania
- UPMC Hillman Cancer Center-UPMC ( Site 6904) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2024-09-20 |
| Est. Completion | 2029-09-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06469944
The ClinicalTrials.gov registry entry for NCT06469944 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 498-participant average among 123 other Esophageal Cancer trials with a reported enrollment target (68% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Esophageal Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT06469944 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Region M. de Santiago, New York, Other.
Frequently Asked Questions
What is clinical trial NCT06469944 about?
NCT06469944 is a clinical study titled "Substudy 06C: A Study of Investigational Agents With Pembrolizumab (MK-3475) and Chemotherapy in Participants With First-Line Locally Advanced Unresectable/Metastatic Gastroesophageal Adenocarcinoma (MK-3475-06C/KEYMAKER-U06)". This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human ...
What is the current status of trial NCT06469944?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2024-09-20. Estimated completion is 2029-09-12.
What conditions does trial NCT06469944 study?
This clinical trial studies the following conditions: Esophageal Cancer, Esophageal Neoplasms, Gastroesophageal Adenocarcinoma, Gastroesophageal Junction.
What interventions are being tested in trial NCT06469944?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Capecitabine (DRUG), Leucovorin (DRUG), Levoleucovorin (DRUG), Sacituzumab Tirumotecan (sac-TMT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06469944?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06469944 being conducted?
This trial has 20 study locations across Arizona, California, Kentucky, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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