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)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

230

Participants

Timeline

Start Date

May 16, 2023

Primary Completion Date

November 7, 2026

Study Completion Date

April 10, 2029

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.

Trial Locations (56)

112

RECRUITING

Taipei Veterans General Hospital ( Site 4005), Taipei

407

RECRUITING

Taichung Veterans General Hospital-Radiation Oncology ( Site 4008), Taichung

704

RECRUITING

National Cheng Kung University Hospital ( Site 4001), Tainan City

1211

RECRUITING

Hôpitaux Universitaires de Genève (HUG) ( Site 4702), Geneva

7000

RECRUITING

Kantonsspital Graubünden-Medizin ( Site 4700), Chur

10002

RECRUITING

National Taiwan University Hospital ( Site 4000), Taipei

10032

COMPLETED

Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907), New York

10330

RECRUITING

Chulalongkorn University ( Site 4104), Bangkok

10700

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 4102), Bangkok

13057

RECRUITING

Hematology-Oncology Associates of Central NY, P.C. ( Site 4925), East Syracuse

13353

COMPLETED

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

15232

RECRUITING

UPMC Hillman Cancer Center-UPMC ( Site 4904), Pittsburgh

20132

RECRUITING

Ospedale San Raffaele-Oncologia Medica ( Site 3202), Milan

20133

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 3200), Milan

20141

COMPLETED

Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative ( Site 3201), Milan

25070

RECRUITING

Atatürk Üniversitesi-onkoloji ( Site 3416), Erzurum

33305

RECRUITING

Chang Gung Medical Foundation-Linkou Branch ( Site 4006), Taoyuan District

34722

RECRUITING

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3403), Istanbul

35128

RECRUITING

Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 3203), Padua

35575

COMPLETED

I.E.U. Medical Point Hastanesi-Oncology ( Site 3406), Izmir

40225

COMPLETED

Universitaetsklinikum Duesseldorf ( Site 4802), Düsseldorf

47014

RECRUITING

"IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori-Oncologia Medica ( Site 3207)", Meldola

56126

RECRUITING

Azienda Ospedaliero Universitaria Pisana ( Site 3206), Pisa

60488

COMPLETED

Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801), Frankfurt am Main

83301

RECRUITING

Chang Gung Memorial Hospital at Kaohsiung ( Site 4003), Kaohsiung Niao Sung Dist

85719

RECRUITING

University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927), Tucson

90110

RECRUITING

Songklanagarind hospital ( Site 4105), Hat Yai

90404

RECRUITING

UCLA Hematology/Oncology - Santa Monica ( Site 4905), Los Angeles

100142

RECRUITING

Beijing Cancer hospital-Digestive Oncology ( Site 3500), Beijing

119074

RECRUITING

National University Hospital ( Site 3800), Singapore

200030

RECRUITING

Shanghai Chest Hospital-Esophageal surgery department ( Site 3513), Shanghai

223300

RECRUITING

First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 3506), Huai'an

230036

RECRUITING

Anhui Provincial Hospital South District ( Site 3501), Hefei

310022

RECRUITING

Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511), Hangzhou

404332

RECRUITING

China Medical University Hospital ( Site 4007), Taichung

453100

RECRUITING

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

3620806

RECRUITING

Saitama Prefectural Cancer Center ( Site 3703), Kitaadachi-gun

7500921

RECRUITING

FALP-UIDO ( Site 4400), Santiago

7560908

RECRUITING

Centro de Oncología de Precisión-Oncology ( Site 4404), Santiago

7591047

COMPLETED

Clínica las Condes ( Site 4403), Santiago

7620002

RECRUITING

Clínica UC San Carlos de Apoquindo ( Site 4405), Santiago

59062-000

RECRUITING

Liga Norte Riograndense Contra o Câncer ( Site 4303), Natal

91350-200

RECRUITING

Hospital Nossa Senhora da Conceição ( Site 4301), Porto Alegre

01246-000

RECRUITING

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300), São Paulo

01307

RECRUITING

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

464-8681

RECRUITING

Aichi Cancer Center ( Site 3702), Nagoya

277-8577

RECRUITING

National Cancer Center Hospital East ( Site 3701), Kashiwa

411-8777

RECRUITING

Shizuoka Cancer Center ( Site 3704), Nagaizumi-cho,Sunto-gun

104-0045

RECRUITING

National Cancer Center Hospital ( Site 3700), Chuo-ku

0379

RECRUITING

Oslo universitetssykehus, Radiumhospitalet ( Site 4501), Oslo

05505

RECRUITING

Asan Medical Center-Department of Oncology ( Site 3901), Seoul

06351

RECRUITING

Samsung Medical Center-Division of Hematology/Oncology ( Site 3900), Seoul

01140

RECRUITING

Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 3417), Adana

06230

COMPLETED

Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402), Ankara

06520

COMPLETED

Memorial Ankara Hastanesi-Medical Oncology ( Site 3408), Ankara

06800

RECRUITING

Ankara Bilkent City Hospital-Medical Oncology ( Site 3405), Ankara

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT05319730 - 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) | Biotech Hunter | Biotech Hunter