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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 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

RecruitingPhase 1, Phase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Esophageal Squamous Cell Carcinoma

Interventions: Paclitaxel, Irinotecan, Pembrolizumab, MK-4830, Lenvatinib

Countries: United States, Brazil, Chile, China, Germany, Italy, Japan, Norway

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
Locations (59)
  • Tucson, Arizona, United States
  • Los Angeles, California, United States
  • East Syracuse, New York, United States
  • New York, New York, United States
  • Pittsburgh, Pennsylvania, United States
  • Natal, Rio Grande do Norte, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • São Paulo, Brazil
  • Santiago, Region M. de Santiago, Chile
  • Santiago, Region M. de Santiago, Chile
  • Santiago, Region M. de Santiago, Chile
  • Santiago, Region M. de Santiago, Chile
  • Hefei, Anhui, China
  • Beijing, Beijing Municipality, China
  • Xiamen, Fujian, China
  • Xinxiang, Henan, China
  • Zhengzhou, Henan, China
  • Huai'an, Jiangsu, China
  • Shanghai, Shanghai Municipality, China
  • Hangzhou, Zhejiang, China
  • Frankfurt am Main, Hesse, Germany
  • Düsseldorf, North Rhine-Westphalia, Germany
  • Dresden, Saxony, Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Meldola, Emilia-Romagna, Italy
  • Milan, Lombardy, Italy
  • Pisa, Tuscany, Italy
  • Padova, Veneto, Italy
  • Milan, Italy
  • + 29 more on CT.gov