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)
A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents With or Without Pembrolizumab (MK-3475) and/or Chemotherapy in Participants With Advanced Esophageal Cancer Previously Exposed to PD-1/PD-L1 Treatment (KEYMAKER-U06): Substudy 06B
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927) — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
- Paclitaxel (DRUG)
- Irinotecan (DRUG)
- Pembrolizumab (BIOLOGICAL)
- MK-4830 (BIOLOGICAL)
- Lenvatinib (DRUG)
- Sacituzumab tirumotecan (BIOLOGICAL)
- Antihistamine (DRUG)
- H2 Receptor Antagonist (DRUG)
- Acetaminophen (or equivalent) (DRUG)
- Dexamethasone (or equivalent) (DRUG)
- Steroid Mouthwash (dexamethasone or equivalent) (DRUG)
- Supportive care measures (DRUG)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (59 Sites)
Showing the first 25 of 59 sites.
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927) — Tucson, Arizona
- UCLA Hematology/Oncology - Santa Monica ( Site 4905) — Los Angeles, California
- Hematology-Oncology Associates of Central NY, P.C. ( Site 4925) — East Syracuse, New York
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907) — New York, New York
- UPMC Hillman Cancer Center-UPMC ( Site 4904) — Pittsburgh, Pennsylvania
- Liga Norte Riograndense Contra o Câncer ( Site 4303) — Natal, Rio Grande do Norte
- Hospital Nossa Senhora da Conceição ( Site 4301) — Porto Alegre, Rio Grande do Sul
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300) — São Paulo,
- FALP-UIDO ( Site 4400) — Santiago, Region M. de Santiago
- Centro de Oncología de Precisión-Oncology ( Site 4404) — Santiago, Region M. de Santiago
- Clínica las Condes ( Site 4403) — Santiago, Region M. de Santiago
- Clínica UC San Carlos de Apoquindo ( Site 4405) — Santiago, Region M. de Santiago
- Anhui Provincial Hospital ( Site 3501) — Hefei, Anhui
- Beijing Cancer hospital-Digestive Oncology ( Site 3500) — Beijing, Beijing Municipality
- The First Affiliated Hospital of Xiamen University ( Site 3516) — Xiamen, Fujian
- The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510) — Xinxiang, Henan
- Henan Cancer Hospital ( Site 3518) — Zhengzhou, Henan
- First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506) — Huai'an, Jiangsu
- Shanghai Chest Hospital-Esophageal surgery department ( Site 3513) — Shanghai, Shanghai Municipality
- Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511) — Hangzhou, Zhejiang
- Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801) — Frankfurt am Main, Hesse
- Universitaetsklinikum Duesseldorf ( Site 4802) — Düsseldorf, North Rhine-Westphalia
- Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 4806) — Dresden, Saxony
- Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804) — Berlin,
- Facharztzentrum Eppendorf ( Site 4807) — Hamburg,
📞 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.
More studies in Esophageal Squamous Cell Carcinoma
- A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy — Fort Myers, Florida
- Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC — Atlanta, Georgia
- Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06) — Pittsburgh, Pennsylvania
- Chemoradiotherapy Followed by Planned Surgery or by Surveillance and Surgery Only When Needed for Oesophageal Cancer — Montreal, Quebec
- A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types — Denver, Colorado
Explore by condition: All Esophageal Squamous Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.