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NCT05319730 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Esophageal Squamous Cell Carcinoma, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT05319730 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 230 participants, below the 370-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 16 states.
The verdict
NCT05319730, 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
- 230 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Paclitaxel
- DRUG Irinotecan
- DRUG Lenvatinib
- BIOLOGICAL MK-4830
Study Locations (20)
Region M. de Santiago
- FALP-UIDO ( Site 4400) - Santiago
- Centro de Oncología de Precisión-Oncology ( Site 4404) - Santiago
- Clínica las Condes ( Site 4403) - Santiago
- Clínica UC San Carlos de Apoquindo ( Site 4405) - Santiago
New York
- Hematology-Oncology Associates of Central NY, P.C. ( Site 4925) - East Syracuse
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907) - New York
Arizona
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927) - Tucson
California
- UCLA Hematology/Oncology - Santa Monica ( Site 4905) - Los Angeles
Pennsylvania
- UPMC Hillman Cancer Center-UPMC ( Site 4904) - Pittsburgh
Rio Grande do Norte
- Liga Norte Riograndense Contra o Câncer ( Site 4303) - Natal
Rio Grande do Sul
- Hospital Nossa Senhora da Conceição ( Site 4301) - Porto Alegre
Other
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300) - São Paulo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2023-05-16 |
| Est. Completion | 2029-04-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05319730
The ClinicalTrials.gov registry entry for NCT05319730 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 230 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 370-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (38% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT05319730 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Region M. de Santiago, New York, Arizona.
Frequently Asked Questions
What is clinical trial NCT05319730 about?
NCT05319730 is a clinical study titled "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)". 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...
What is the current status of trial NCT05319730?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 230 participants. The study started on 2023-05-16. Estimated completion is 2029-04-10.
What conditions does trial NCT05319730 study?
This clinical trial studies the following conditions: Esophageal Squamous Cell Carcinoma.
What interventions are being tested in trial NCT05319730?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Paclitaxel (DRUG), Irinotecan (DRUG), Lenvatinib (DRUG), MK-4830 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05319730?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05319730 being conducted?
This trial has 20 study locations across Arizona, California, New York, Pennsylvania, Rio Grande do Norte. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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