N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT05319730

Registry updated: 2026-10-07
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

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.

Interventions

  • Paclitaxel (Drug)
    80-100 mg/m\^2 IV infusion, administered on days 1, 8, and 15 of every 28-day cycle.
  • Irinotecan (Drug)
    180 mg/m\^2 IV infusion, administered on day 1 of every 14-day cycle.
  • Pembrolizumab (Biological)
    200 mg IV infusion, administered every Q3W up to 35 infusions.
  • MK-4830 (Biological)
    800 mg IV infusion, administered Q3W up to 35 infusions.
  • Lenvatinib (Drug)
    20 mg oral administration every day.
  • Sacituzumab tirumotecan (Biological)
    4 mg/kg or 5 mg/kg IV infusion on Days 1, 15, and 29 of each 42-day cycle.
  • Antihistamine (Drug)
    Administered per product label.
  • H2 Receptor Antagonist (Drug)
    Administered per product label.
  • Acetaminophen (or equivalent) (Drug)
    Administered per product label.
  • Dexamethasone (or equivalent) (Drug)
    Administered per product label.
  • Steroid Mouthwash (dexamethasone or equivalent) (Drug)
    Administered per product label.
  • Supportive care measures (Drug)
    Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Artificial tear drops or ointment may be given as a supportive care for Ocular Surface Toxicity.

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

Conditions

Esophageal Squamous Cell Carcinoma

Locations

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927) — Tucson, Arizona, United States
  • UCLA Hematology/Oncology - Santa Monica ( Site 4905) — Los Angeles, California, United States
  • Hematology-Oncology Associates of Central NY, P.C. ( Site 4925) — East Syracuse, New York, United States
  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907) — New York, New York, United States
  • UPMC Hillman Cancer Center-UPMC ( Site 4904) — Pittsburgh, Pennsylvania, United States
  • Liga Norte Riograndense Contra o Câncer ( Site 4303) — Natal, Rio Grande do Norte, Brazil
  • Hospital Nossa Senhora da Conceição ( Site 4301) — Porto Alegre, Rio Grande do Sul, Brazil
  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300) — São Paulo, Brazil
  • FALP-UIDO ( Site 4400) — Santiago, Region M. de Santiago, Chile
  • Centro de Oncología de Precisión-Oncology ( Site 4404) — Santiago, Region M. de Santiago, Chile
  • Clínica las Condes ( Site 4403) — Santiago, Region M. de Santiago, Chile
  • Clínica UC San Carlos de Apoquindo ( Site 4405) — Santiago, Region M. de Santiago, Chile
  • Anhui Provincial Hospital ( Site 3501) — Hefei, Anhui, China
  • Beijing Cancer hospital-Digestive Oncology ( Site 3500) — Beijing, Beijing Municipality, China
  • The First Affiliated Hospital of Xiamen University ( Site 3516) — Xiamen, Fujian, China
  • The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510) — Xinxiang, Henan, China
  • Henan Cancer Hospital ( Site 3518) — Zhengzhou, Henan, China
  • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506) — Huai'an, Jiangsu, China
  • Shanghai Chest Hospital-Esophageal surgery department ( Site 3513) — Shanghai, Shanghai Municipality, China
  • Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511) — Hangzhou, Zhejiang, China
  • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 4807) — Erdgeschoss, Free and Hanseatic City of Hamburg, Germany
  • Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801) — Frankfurt am Main, Hesse, Germany
  • Universitaetsklinikum Duesseldorf ( Site 4802) — Düsseldorf, North Rhine-Westphalia, Germany
  • Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804) — Berlin, Germany
  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 3207) — Meldola, Emilia-Romagna, Italy
  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200) — Milan, Lombardy, Italy
  • Azienda Ospedaliero Universitaria Pisana ( Site 3206) — Pisa, Tuscany, Italy
  • Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203) — Padova, Veneto, Italy
  • Ospedale San Raffaele-Oncologia Medica ( Site 3202) — Milan, Italy
  • Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Site 3201) — Milan, Italy
  • Aichi Cancer Center ( Site 3702) — Nagoya, Aichi-ken, Japan
  • National Cancer Center Hospital East ( Site 3701) — Kashiwa, Chiba, Japan
  • Saitama Prefectural Cancer Center ( Site 3703) — Kitaadachi-gun, Saitama, Japan
  • Shizuoka Cancer Center ( Site 3704) — Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
  • National Cancer Center Hospital ( Site 3700) — Chuo-ku, Tokyo, Japan
  • Oslo universitetssykehus, Radiumhospitalet ( Site 4501) — Oslo, Norway
  • National University Hospital ( Site 3800) — Singapore, South West, Singapore
  • Asan Medical Center-Department of Oncology ( Site 3901) — Seoul, South Korea
  • Samsung Medical Center-Division of Hematology/Oncology ( Site 3900) — Seoul, South Korea
  • Hôpitaux Universitaires de Genève (HUG) ( Site 4702) — Geneva, Canton of Geneva, Switzerland
  • Kantonsspital Graubünden-Medizin ( Site 4700) — Chur, Kanton Graubünden, Switzerland
  • Chang Gung Memorial Hospital at Kaohsiung ( Site 4003) — Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
  • China Medical University Hospital ( Site 4007) — Taichung, Taiwan
  • Taichung Veterans General Hospital-Radiation Oncology ( Site 4008) — Taichung, Taiwan
  • National Cheng Kung University Hospital ( Site 4001) — Tainan, Taiwan
  • National Taiwan University Hospital ( Site 4000) — Taipei, Taiwan
  • Taipei Veterans General Hospital ( Site 4005) — Taipei, Taiwan
  • Chang Gung Medical Foundation-Linkou Branch ( Site 4006) — Taoyuan, Taiwan
  • Faculty of Medicine Siriraj Hospital ( Site 4102) — Bangkoknoi, Bangkok, Thailand
  • Chulalongkorn University ( Site 4104) — Pathumwan, Bangkok, Thailand
  • Songklanagarind hospital ( Site 4105) — Hat Yai, Changwat Songkhla, Thailand
  • Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3417) — Adana, Turkey (Türkiye)
  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402) — Ankara, Turkey (Türkiye)
  • Memorial Ankara Hastanesi-Medical Oncology ( Site 3408) — Ankara, Turkey (Türkiye)
  • Ankara Bilkent City Hospital-Medical Oncology ( Site 3405) — Ankara, Turkey (Türkiye)
  • Atatürk Üniversitesi-onkoloji ( Site 3416) — Erzurum, Turkey (Türkiye)
  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403) — Istanbul, Turkey (Türkiye)
  • I.E.U. Medical Point Hastanesi-Oncology ( Site 3406) — Izmir, Turkey (Türkiye)
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record