🏛️ Verified NIH Record • Updated 2026-08-21

Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06) (NCT06780111)

A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts. Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing. Researchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. The main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.

Who can join: Review the eligibility criteria below.

Location: UPMC Hillman Cancer Center ( Site 1904) — Pittsburgh, Pennsylvania

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (45 Sites)

Showing the first 25 of 45 sites.

  • UPMC Hillman Cancer Center ( Site 1904) — Pittsburgh, Pennsylvania
  • Liga Norte Riograndense Contra o Cancer ( Site 1301) — Natal, Rio Grande do Norte
  • Hospital Nossa Senhora da Conceicao ( Site 1300) — Porto Alegre, Rio Grande do Sul
  • IBCC - Instituto Brasileiro de Controle do Cancer ( Site 1303) — São Paulo, São Paulo
  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1302) — São Paulo,
  • Clínica Puerto Montt ( Site 1406) — Port Montt, Los Lagos Region
  • FALP ( Site 1400) — Santiago, Region M. de Santiago
  • Centro de Oncología de Precisión ( Site 1402) — Santiago, Region M. de Santiago
  • Clínica UC San Carlos de Apoquindo ( Site 1403) — Santiago, Region M. de Santiago
  • Bradfordhill ( Site 1401) — Santiago, Region M. de Santiago
  • Bradford Hill Norte ( Site 1405) — Antofagasta,
  • The Second Affiliated Hospital of Anhui Medical University ( Site 9511) — Hefei, Anhui
  • Beijing Cancer Hospital ( Site 9500) — Beijing, Beijing Municipality
  • The First Affiliated Hospital of Xiamen University ( Site 9503) — Xiamen, Fujian
  • Henan Cancer Hospital ( Site 9509) — Zhengzhou, Henan
  • Xuzhou Central Hospital ( Site 9512) — Xuzhou, Jiangsu
  • The First Affiliated Hospital of Nanchang University ( Site 9505) — Nanchang, Jiangxi
  • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000) — Brno, Brno-mesto
  • C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104) — Brest, Finistere
  • CHU Lille - Institut Coeur Poumon ( Site 9100) — Lille, Nord
  • Pitie Salpetriere University Hospital ( Site 9102) — Paris,
  • Universitaetsklinikum Duesseldorf ( Site 1808) — Düsseldorf, North Rhine-Westphalia
  • Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806) — Dresden, Saxony
  • Haematologisch-Onkologische Praxis Eppendorf Facharztzentrum Eppendorf - Hope ( Site 1807) — Hamburg,
  • Ospedale San Raffaele-Oncologia Medica ( Site 9201) — Milan, Lombardy

📞 Contact the Study Coordinator

Phone: (888) 577-8839

Email: Trialsites@msd.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗