NCT05319730RecruitingPhase 1/2
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 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
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 230 (estimated)
- First submitted
- 1 Apr 2022
- Start date
- 16 May 2023
- Primary completion date
- 11 Jun 2027
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05319730
- EU CT number
- 2023-505189-26-00
- EudraCT number
- 2021-005443-76
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 230
- From 16 May 2023 to the primary completion date, 11 Jun 2027
- 58 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has experienced weight loss \>10% over approximately 2 months prior to first dose of study therapy
- 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
- 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
Other illness
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- 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
- 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
Other
- Direct invasion into adjacent organs such as the aorta or trachea
- Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Who the study is looking for
- 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
Criteria the registry did not label
- The main inclusion and exclusion criteria include but are not limited to the following:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (58)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Liga Norte Riograndense Contra o Câncer ( Site 4303) Coordinator of this site? Confirm its status | Natal | Brazil | Recruiting |
| Hospital Nossa Senhora da Conceição ( Site 4301) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Kantonsspital Graubünden-Medizin ( Site 4700) Coordinator of this site? Confirm its status | Chur | Switzerland | Recruiting |
| Hôpitaux Universitaires de Genève (HUG) ( Site 4702) Coordinator of this site? Confirm its status | Geneva | Switzerland | Recruiting |
| Clínica UC San Carlos de Apoquindo ( Site 4405) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Clínica las Condes ( Site 4403) Coordinator of this site? Confirm its status | Santiago | Chile | Completed |
| FALP-UIDO ( Site 4400) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Centro de Oncología de Precisión-Oncology ( Site 4404) Coordinator of this site? Confirm its status | Santiago | Chile | Recruiting |
| Beijing Cancer hospital-Digestive Oncology ( Site 3500) Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511) Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Anhui Provincial Hospital ( Site 3501) Coordinator of this site? Confirm its status | Hefei | China | Recruiting |
| First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506) Coordinator of this site? Confirm its status | Huai'an | China | Recruiting |
| Shanghai Chest Hospital-Esophageal surgery department ( Site 3513) Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| The First Affiliated Hospital of Xiamen University ( Site 3516) Coordinator of this site? Confirm its status | Xiamen | China | Recruiting |
| The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510) Coordinator of this site? Confirm its status | Xinxiang | China | Recruiting |
| Henan Cancer Hospital ( Site 3518) Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804) Coordinator of this site? Confirm its status | Berlin | Germany | Completed |
| Universitaetsklinikum Duesseldorf ( Site 4802) Coordinator of this site? Confirm its status | Düsseldorf | Germany | Completed |
| HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 4807) Coordinator of this site? Confirm its status | Erdgeschoss | Germany | Recruiting |
| Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801) Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Completed |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 3207) Coordinator of this site? Confirm its status | Meldola | Italy | Recruiting |
| Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Site 3201) Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200) Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele-Oncologia Medica ( Site 3202) Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203) Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana ( Site 3206) Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| National Cancer Center Hospital ( Site 3700) Coordinator of this site? Confirm its status | Chuo-ku | Japan | Recruiting |
| National Cancer Center Hospital East ( Site 3701) Coordinator of this site? Confirm its status | Kashiwa | Japan | Recruiting |
| Saitama Prefectural Cancer Center ( Site 3703) Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Recruiting |
| Shizuoka Cancer Center ( Site 3704) Coordinator of this site? Confirm its status | Nagaizumi-cho,Sunto-gun | Japan | Recruiting |
| Aichi Cancer Center ( Site 3702) Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Asan Medical Center-Department of Oncology ( Site 3901) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center-Division of Hematology/Oncology ( Site 3900) Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Oslo universitetssykehus, Radiumhospitalet ( Site 4501) Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| National University Hospital ( Site 3800) Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| Faculty of Medicine Siriraj Hospital ( Site 4102) Coordinator of this site? Confirm its status | Bangkoknoi | Thailand | Recruiting |
| Songklanagarind hospital ( Site 4105) Coordinator of this site? Confirm its status | Hat Yai | Thailand | Recruiting |
| Chulalongkorn University ( Site 4104) Coordinator of this site? Confirm its status | Pathumwan | Thailand | Recruiting |
| Chang Gung Memorial Hospital at Kaohsiung ( Site 4003) Coordinator of this site? Confirm its status | Kaohsiung Niao Sung Dist | Taiwan | Recruiting |
| Taichung Veterans General Hospital-Radiation Oncology ( Site 4008) Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| China Medical University Hospital ( Site 4007) Coordinator of this site? Confirm its status | Taichung | Taiwan | Recruiting |
| National Cheng Kung University Hospital ( Site 4001) Coordinator of this site? Confirm its status | Tainan | Taiwan | Completed |
| National Taiwan University Hospital ( Site 4000) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Taipei Veterans General Hospital ( Site 4005) Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| Chang Gung Medical Foundation-Linkou Branch ( Site 4006) Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Recruiting |
| Hematology-Oncology Associates of Central NY, P.C. ( Site 4925) Coordinator of this site? Confirm its status | East Syracuse | United States | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 4905) Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907) Coordinator of this site? Confirm its status | New York | United States | Completed |
| UPMC Hillman Cancer Center-UPMC ( Site 4904) Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927) Coordinator of this site? Confirm its status | Tucson | United States | Recruiting |
| Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3417) Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Recruiting |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Completed |
| Ankara Bilkent City Hospital-Medical Oncology ( Site 3405) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Memorial Ankara Hastanesi-Medical Oncology ( Site 3408) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Completed |
| Atatürk Üniversitesi-onkoloji ( Site 3416) Coordinator of this site? Confirm its status | Erzurum | Turkey (Türkiye) | Recruiting |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Recruiting |
| I.E.U. Medical Point Hastanesi-Oncology ( Site 3406) Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.