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)
Public ClinicalTrials.gov record NCT05319730. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05319730
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 230 participants
Conditions and interventions
Conditions
Interventions
- Paclitaxel Drug
- Irinotecan Drug
- Pembrolizumab Biological
- MK-4830 Biological
- Lenvatinib Drug
- Sacituzumab tirumotecan Biological
- Antihistamine Drug
- H2 Receptor Antagonist Drug
- Acetaminophen (or equivalent) Drug
- Dexamethasone (or equivalent) Drug
- Steroid Mouthwash (dexamethasone or equivalent) Drug
- Supportive care measures Drug
Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 15, 2023
- Primary completion
- Jun 10, 2027
- Completion
- Apr 9, 2029
- Last update posted
- Sep 1, 2026
2023 – 2029
United States locations
- U.S. sites
- 5
- U.S. states
- 4
- U.S. cities
- 5
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927) | Tucson | Arizona | 85719 | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 4905) | Los Angeles | California | 90404 | Recruiting |
| Hematology-Oncology Associates of Central NY, P.C. ( Site 4925) | East Syracuse | New York | 13057 | Recruiting |
| Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907) | New York | New York | 10032 | Completed |
| UPMC Hillman Cancer Center-UPMC ( Site 4904) | Pittsburgh | Pennsylvania | 15232 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05319730, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 1, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05319730 live on ClinicalTrials.gov.