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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: Recruiting Phase 1 study of Esophageal Squamous Cell Carcinoma, sponsored by Merck Sharp & Dohme.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

A DLT is defined as any drug-related AE according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.

Conditions Studied

Esophageal Squamous Cell Carcinoma

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

FieldValue
Enrollment Target 230 participants
Start Date 2023-05-16
Est. Completion 2029-04-10
Phase Phase 1
Merck Sharp & Dohme

558 total trials

What NCT05319730 shows while recruiting

NCT05319730 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 370-participant average among 22 other Esophageal Squamous Cell Carcinoma trials with a reported enrollment target (38% 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.

NCT05319730 names 20 study sites across 16 states, led by 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.

Learn More About Clinical Trials

Similar trials for Esophageal Squamous Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05319730's enrollment target sits among peer trials

230 11th of 22 higher than 12 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05319730

Source: ClinicalTrials.gov NCT05319730, the US trial registry maintained by the National Library of Medicine. NCT05319730 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.