Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT05319730 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. 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 230 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: NCT05319730 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Region M. de Santiago, New York, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05319730?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Paclitaxel (DRUG), Irinotecan (DRUG), Lenvatinib (DRUG), MK-4830 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05319730?
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 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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.