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)

Recruiting now · Phase 1/Phase 2

Conditions studied: Esophageal Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT05319730

Run by

Merck Sharp & Dohme LLC

People needed

230

Starts

2023-05-16

Expected to finish

2029-04-10

Last updated by the study team

2026-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable esophageal squamous cell carcinoma (ESCC)
• Has experienced investigator documented radiographic or clinical disease progression on one prior line of standard therapy, that includes a platinum agent and previous exposure to an anti-programmed cell death 1 (PD1)/programmed cell death ligand 1 (PD-L1) based immune oncology (IO) therapy
• Has provided an archival or most recent tumor tissue sample obtained as part of clinical practice
• Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible

You may not qualify if…

• Direct invasion into adjacent organs such as the aorta or trachea
• Has experienced weight loss >10% over approximately 2 months prior to first dose of study therapy
• Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
• Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
• Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
• Known additional malignancy that is progressing or has required active treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ that has undergone potentially curative therapy
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
• Participants with human immunodeficiency virus (HIV) with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• History of allogenic tissue/solid organ transplant
• Clinically significant cardiovascular disease within 12 months from first dose of study intervention
• Has risk for significant gastrointestinal (GI) bleeding such as a serious nonhealing wound, peptic ulcer, or bone fracture within 28 days prior to allocation/randomization, significant bleeding disorders, vasculitis, or has had a significant bleeding episode from the GI tract within 12 weeks prior to allocation/randomization

Where it is running

• Azienda Ospedaliero Universitaria Pisana ( Site 3206) — Pisa, Tuscany, Italy (enrolling)
• Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203) — Padova, Veneto, Italy (enrolling)
• UCLA Hematology/Oncology - Santa Monica ( Site 4905) — Los Angeles, California, United States (enrolling)
• Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200) — Milan, Lombardy, Italy (enrolling)
• Hematology-Oncology Associates of Central NY, P.C. ( Site 4925) — East Syracuse, New York, United States (enrolling)
• Hospital Nossa Senhora da Conceição ( Site 4301) — Porto Alegre, Rio Grande do Sul, Brazil (enrolling)
• ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300) — São Paulo, Brazil (enrolling)
• FALP-UIDO ( Site 4400) — Santiago, Region M. de Santiago, Chile (enrolling)
• University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927) — Tucson, Arizona, United States (enrolling)
• IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 3207) — Meldola, Emilia-Romagna, Italy (enrolling)
• Liga Norte Riograndense Contra o Câncer ( Site 4303) — Natal, Rio Grande do Norte, Brazil (enrolling)
• Anhui Provincial Hospital ( Site 3501) — Hefei, Anhui, China (enrolling)
• Beijing Cancer hospital-Digestive Oncology ( Site 3500) — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Xiamen University ( Site 3516) — Xiamen, Fujian, China (enrolling)
• The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510) — Xinxiang, Henan, China (enrolling)
• Henan Cancer Hospital ( Site 3518) — Zhengzhou, Henan, China (enrolling)
• First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506) — Huai'an, Jiangsu, China (enrolling)
• Shanghai Chest Hospital-Esophageal surgery department ( Site 3513) — Shanghai, Shanghai Municipality, China (enrolling)
• Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511) — Hangzhou, Zhejiang, China (enrolling)
• Centro de Oncología de Precisión-Oncology ( Site 4404) — Santiago, Region M. de Santiago, Chile (enrolling)
• UPMC Hillman Cancer Center-UPMC ( Site 4904) — Pittsburgh, Pennsylvania, United States (enrolling)
• Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 4806) — Dresden, Saxony, Germany (enrolling)
• Clínica UC San Carlos de Apoquindo ( Site 4405) — Santiago, Region M. de Santiago, Chile (enrolling)
• Facharztzentrum Eppendorf ( Site 4807) — Hamburg, Germany (enrolling)
• Ospedale San Raffaele-Oncologia Medica ( Site 3202) — Milan, Italy (enrolling)

Full record on ClinicalTrials.gov

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