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RECRUITING

NCT05319730

PHASE1/PHASE2

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

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

230

Start Date

2023-05-16

Completion Date

2029-04-10

Last Updated

2026-03-20

Healthy Volunteers

No

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

DRUG

Paclitaxel

80-100 mg/m\^2 IV infusion, administered on days 1, 8, and 15 of every 28-day cycle.

DRUG

Irinotecan

180 mg/m\^2 IV infusion, administered on day 1 of every 14-day cycle.

BIOLOGICAL

Pembrolizumab

200 mg IV infusion, administered every Q3W up to 35 infusions.

BIOLOGICAL

MK-4830

800 mg IV infusion, administered Q3W up to 35 infusions.

DRUG

Lenvatinib

20 mg oral administration every day.

BIOLOGICAL

Sacituzumab tirumotecan

4 mg/kg or 5 mg/kg IV infusion on Days 1, 15, and 29 of each 42-day cycle.

DRUG

Antihistamine

Administered per product label.

DRUG

H2 Receptor Antagonist

Administered per product label.

DRUG

Acetaminophen (or equivalent)

Administered per product label.

DRUG

Dexamethasone (or equivalent)

Administered per product label.

DRUG

Steroid Mouthwash (dexamethasone or equivalent)

Administered per product label.

DRUG

Supportive care measures

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.

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 (57)

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 South District ( Site 3501)

Hefei, Anhui, China

Beijing Cancer hospital-Digestive Oncology ( Site 3500)

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Xinxiang Medical University-Oncology ( Site 3510)

Xinxiang, 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

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

Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 4806)

Dresden, Saxony, Germany

Charité Campus Virchow-Klinikum-Klinik Hämatologie Onkologie Tumorimmunologie ( Site 4804)

Berlin, Germany

Facharztzentrum Eppendorf ( Site 4807)

Hamburg, 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 District, Taiwan

Chulalongkorn University ( Site 4104)

Bangkok, Bangkok, Thailand

Faculty of Medicine Siriraj Hospital ( Site 4102)

Bangkok, 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)