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Clinical Trial Summary

This is a phase I/II multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of investigational agents with pembrolizumab, plus chemotherapy or lenvatinib, for the treatment of participants with advanced esophageal cancer who have failed 1 prior line of therapy and have not been previously exposed to programmed cell death 1 protein (PD-1)/ programmed cell death ligand 1 (PD-L1) based treatment. With protocol amendment 5 (effective: 17-November-2023), enrollment in study arms "Pembrolizumab plus MK-4830 plus Chemotherapy" and "Pembrolizumab plus MK-4830 plus lenvatinib" is discontinued.


Clinical Trial Description

The master protocol is MK-3475-U06. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05342636
Study type Interventional
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Status Recruiting
Phase Phase 1/Phase 2
Start date July 27, 2022
Completion date September 21, 2026

See also
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Active, not recruiting NCT03957590 - Study of Tislelizumab (BGB-A317) Versus Placebo in Combination With Chemoradiotherapy in Participant With ESCC Phase 3
Completed NCT03430843 - A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma Phase 3
Active, not recruiting NCT04210115 - Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) Phase 3
Not yet recruiting NCT05473156 - A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies Phase 1/Phase 2
Active, not recruiting NCT03783442 - A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma Phase 3
Enrolling by invitation NCT04839471 - BI-754091 and Afatinib for Refractory Esophageal Squamous Cell Carcinoma (BEAR Study) Phase 2