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Esophageal Squamous Cell CarcinomaPhase 1/2NCT05319730

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 study testing Paclitaxel, Irinotecan and Pembrolizumab in people with Esophageal Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 58 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Paclitaxel, Irinotecan and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
230 participants
Where
58 sitesin 14 countries
Study dates
16 May 2023to 10 Apr 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

58 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

58 sites in 14 countries

China8 sites, 8 recruiting

  • Beijing Cancer hospital-Digestive Oncology ( Site 3500)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, 010-88121122

    Recruiting

  • Zhejiang Cancer Hospital-Thoracic oncology ( Site 3511)

    Hangzhou, Zhejiang, 310022

    Study Coordinator, 86 13858182310

    Recruiting

  • Anhui Provincial Hospital ( Site 3501)

    Hefei, Anhui, 230001

    Study Coordinator, +8613955195511

    Recruiting

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

    Huai'an, Jiangsu, 223300

    Study Coordinator, 0517-84992012

    Recruiting

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

    Shanghai, Shanghai Municipality, 200030

    Study Coordinator, +86 21 22200000

    Recruiting

  • The First Affiliated Hospital of Xiamen University ( Site 3516)

    Xiamen, Fujian, 361003

    Study Coordinator, +865922139767

    Recruiting

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

    Xinxiang, Henan, 453100

    Study Coordinator, 8613663030446

    Recruiting

  • Henan Cancer Hospital ( Site 3518)

    Zhengzhou, Henan, 450008

    Study Coordinator, +8637165587625

    Recruiting

Other trials in China

Taiwan7 sites, 6 recruiting

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 4003)

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

    Study Coordinator, +88677317123x3267

    Recruiting

  • China Medical University Hospital ( Site 4007)

    Taichung, 404332

    Study Coordinator, +886975680932

    Recruiting

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

    Taichung, 407

    Study Coordinator, +886423592525

    Recruiting

  • National Cheng Kung University Hospital ( Site 4001)

    Tainan, 704

    Completed

  • National Taiwan University Hospital ( Site 4000)

    Taipei, 10002

    Study Coordinator, +886223123456

    Recruiting

  • Taipei Veterans General Hospital ( Site 4005)

    Taipei, 112

    Study Coordinator, +8862287121212573

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch ( Site 4006)

    Taoyuan, 33305

    Study Coordinator, +88633281200

    Recruiting

Other trials in Taiwan

Turkey (Türkiye)7 sites, 4 recruiting

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

    Adana, 01140

    Study Coordinator, 00902124444484

    Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 3402)

    Ankara, 06230

    Completed

  • Memorial Ankara Hastanesi-Medical Oncology ( Site 3408)

    Ankara, 06520

    Completed

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

    Ankara, 06800

    Study Coordinator, 90 312 552 60 00

    Recruiting

  • Atatürk Üniversitesi-onkoloji ( Site 3416)

    Erzurum, 25070

    Study Coordinator, +904423447232

    Recruiting

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

    Istanbul, 34722

    Study Coordinator, 00902166065200

    Recruiting

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

    Izmir, 35575

    Completed

Other trials in Turkey (Türkiye)

Italy6 sites, 5 recruiting

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

    Meldola, Emilia-Romagna, 47014

    Study Coordinator, 0543739100

    Recruiting

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

    Milan, Lombardy, 20133

    Study Coordinator, 390223903835

    Recruiting

  • Ospedale San Raffaele-Oncologia Medica ( Site 3202)

    Milan, 20132

    Study Coordinator, +390226437615

    Recruiting

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

    Milan, 20141

    Completed

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

    Padova, Veneto, 35128

    Study Coordinator, 390498215910

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana ( Site 3206)

    Pisa, Tuscany, 56126

    Study Coordinator, +39050992454

    Recruiting

Other trials in Italy

United States5 sites, 4 recruiting

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

    East Syracuse, New York, 13057

    Study Coordinator, 315-472-7504

    Recruiting

  • UCLA Hematology/Oncology - Santa Monica ( Site 4905)

    Los Angeles, California, 90404

    Study Coordinator, 310-570-1453

    Recruiting

  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 4907)

    New York, New York, 10032

    Completed

  • UPMC Hillman Cancer Center-UPMC ( Site 4904)

    Pittsburgh, Pennsylvania, 15232

    Study Coordinator, 816-898-9413

    Recruiting

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 4927)

    Tucson, Arizona, 85719

    Study Coordinator, 520-621-2449

    Recruiting

Other trials in United States

Japan5 sites, 5 recruiting

  • National Cancer Center Hospital ( Site 3700)

    Chuo-ku, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • National Cancer Center Hospital East ( Site 3701)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • Saitama Prefectural Cancer Center ( Site 3703)

    Kitaadachi-gun, Saitama, 3620806

    Study Coordinator, +81-48-722-1111

    Recruiting

  • Shizuoka Cancer Center ( Site 3704)

    Nagaizumi-cho,Sunto-gun, Shizuoka, 411-8777

    Study Coordinator, +81-55-989-5222

    Recruiting

  • Aichi Cancer Center ( Site 3702)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

Other trials in Japan

Chile4 sites, 3 recruiting

  • FALP-UIDO ( Site 4400)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Centro de Oncología de Precisión-Oncology ( Site 4404)

    Santiago, Region M. de Santiago, 7560908

    Study Coordinator, +56225189885

    Recruiting

  • Clínica las Condes ( Site 4403)

    Santiago, Region M. de Santiago, 7591047

    Completed

  • Clínica UC San Carlos de Apoquindo ( Site 4405)

    Santiago, Region M. de Santiago, 7620002

    Study Coordinator, +56934271024

    Recruiting

Other trials in Chile

Germany4 sites, 1 recruiting

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

    Berlin, 13353

    Completed

  • Universitaetsklinikum Duesseldorf ( Site 4802)

    Düsseldorf, North Rhine-Westphalia, 40225

    Completed

  • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 4807)

    Erdgeschoss, Free and Hanseatic City of Hamburg, 22297

    Study Coordinator, + 4940360352246

    Recruiting

  • Institut für Klinisch Onkologische Forschung-Klink für Onkologie und Hämatologie ( Site 4801)

    Frankfurt am Main, Hesse, 60488

    Completed

Other trials in Germany

Brazil3 sites, 3 recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 4303)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +55 84 4009-5595

    Recruiting

  • Hospital Nossa Senhora da Conceição ( Site 4301)

    Porto Alegre, Rio Grande do Sul, 91350-200

    Study Coordinator, +5551985833768

    Recruiting

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 4300)

    São Paulo, 01246-000

    Study Coordinator, +551138934656

    Recruiting

Other trials in Brazil

Thailand3 sites, 3 recruiting

  • Faculty of Medicine Siriraj Hospital ( Site 4102)

    Bangkoknoi, Bangkok, 10700

    Study Coordinator, +6624194488

    Recruiting

  • Songklanagarind hospital ( Site 4105)

    Hat Yai, Changwat Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

  • Chulalongkorn University ( Site 4104)

    Pathumwan, Bangkok, 10330

    Study Coordinator, +ุ6622564533

    Recruiting

Other trials in Thailand

South Korea2 sites, 2 recruiting

  • Asan Medical Center-Department of Oncology ( Site 3901)

    Seoul, 05505

    Study Coordinator, +82230107179

    Recruiting

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

    Seoul, 06351

    Study Coordinator, +82234106518

    Recruiting

Other trials in South Korea

Switzerland2 sites, 2 recruiting

  • Kantonsspital Graubünden-Medizin ( Site 4700)

    Chur, Kanton Graubünden, 7000

    Study Coordinator, +41 81 256 61 11

    Recruiting

  • Hôpitaux Universitaires de Genève (HUG) ( Site 4702)

    Geneva, Canton of Geneva, 1211

    Study Coordinator, +41 22 372 29 01

    Recruiting

Other trials in Switzerland

Norway1 site, 1 recruiting

  • Oslo universitetssykehus, Radiumhospitalet ( Site 4501)

    Oslo, 0379

    Study Coordinator, 4723026600

    Recruiting

Other trials in Norway

Singapore1 site, 1 recruiting

  • National University Hospital ( Site 3800)

    Singapore, South West, 119074

    Study Coordinator, +65 6908 2222

    Recruiting

Other trials in Singapore

About this study

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

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.

Read the detailed description

The master protocol is MK-3475-U06.

As of Protocol Amendment 5, the Pembrolizumab Plus MK-4830 Plus Paclitaxel/Irinotecan arm and the Pembrolizumab Plus MK-4830 Plus Lenvatinib arm are no longer actively enrolling participants.

Keywords
Esophageal cancer, Programmed Cell Death 1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1 (PDL-1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL-2, PD-L2)
Medical subject headings
Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

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

  • IrinotecanDrug

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

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

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

  • MK-4830Biological

    Also called anti-immunoglobulin-like transcript 4 (anti-ILT4)

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

  • LenvatinibDrug

    Also called MK-7902, LENVIMA®

    20 mg oral administration every day.

  • Sacituzumab tirumotecanBiological

    Also called SKB264, MK-2870, sac-TMT

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

  • AntihistamineDrug

    Administered per product label.

  • H2 Receptor AntagonistDrug

    Administered per product label.

  • Acetaminophen (or equivalent)Drug

    Administered per product label.

  • Dexamethasone (or equivalent)Drug

    Administered per product label.

  • Steroid Mouthwash (dexamethasone or equivalent)Drug

    Administered per product label.

  • Supportive care measuresDrug

    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.

Study groups in NCT05319730
Study groupRoleWhat they receive
Paclitaxel or irinotecanActive comparatorParticipants receive paclitaxel 80-100 mg/m^2 intravenously (IV) on Days 1, 8, and 15 every 28-day cycle until progressive disease (PD) or discontinuation, or irinotecan 180 mg/m^2 IV on day 1 of every 14-day cycle until PD or discontinuation.
Receives: Drug: Paclitaxel; Drug: Irinotecan
Pembrolizumab + MK-4830 + paclitaxel or irinotecanExperimentalParticipants receive pembrolizumab 200 mg IV once every 3 weeks (Q3W) for up to 35 cycles (cycle=21 days) or until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + paclitaxel 80-100 mg/m^2 IV on Days 1, 8, and 15 every 28-day cycle until PD or discontinuation or irinotecan 180 mg/m^2 180 mg/m^2 on day 1 every 14-day cycle until PD or discontinuation.
Receives: Drug: Paclitaxel; Drug: Irinotecan; Biological: Pembrolizumab; Biological: MK-4830
Pembrolizumab + MK-4830 + lenvatinibExperimentalParticipants receive pembrolizumab 200 mg IV Q3W up to 35 cycles (cycle=21 days) until PD or discontinuation + MK-4830 800 mg IV Q3W up to 35 infusions + lenvatinib 20 mg oral administration every day until PD or discontinuation.
Receives: Biological: Pembrolizumab; Biological: MK-4830; Drug: Lenvatinib
Sacituzumab tirumotecan 4 mg/kgExperimentalParticipants will receive 4 mg/kg of sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 of each 42-day cycle until discontinuation.
Receives: Biological: Sacituzumab tirumotecan; Drug: Antihistamine; Drug: H2 Receptor Antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid Mouthwash (dexamethasone or equivalent); Drug: Supportive care measures
Sacituzumab tirumotecan 5 mg/kgExperimentalParticipants will receive 5 mg/kg of sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 of each 42-day cycle until discontinuation.
Receives: Biological: Sacituzumab tirumotecan; Drug: Antihistamine; Drug: H2 Receptor Antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Steroid Mouthwash (dexamethasone or equivalent); Drug: Supportive care measures

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) During Safety Lead-in Phase

    A DLT is defined as any drug-related AE according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.

    Measured: Up to approximately 3 weeks

  2. Number of Participants Who Experienced an Adverse Event (AE) During Safety Lead-in Phase

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

    Measured: Up to approximately 3 weeks

  3. Number of Participants Who Discontinue Study Treatment Due to an AE During Safety Lead-in Phase

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.

    Measured: Up to approximately 3 weeks

  4. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.

    Measured: Up to approximately 48 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from allocation to the first documented progressive disease (PD) as assessed by RECIST 1.1 or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.

    Measured: Up to approximately 70 months

  2. Duration of Response (DOR)

    For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.

    Measured: Up to approximately 70 months

  3. Overall Survival (OS)

    OS is defined as the time from the date of allocation to death from any cause.

    Measured: Up to approximately 70 months

  4. Number of Participants Experiencing at Least One Adverse Event (AE) During the Efficacy Phase

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 70 months

  5. Number of Participants Who Discontinue Study Treatment Due to An AE During the Efficacy Phase

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 70 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start16 May 2023
  3. Primary completion11 Jun 2027 (estimated)
  4. Study completion10 Apr 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
230 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05319730
Sponsor's protocol ID
3475-06B
Other IDs
jRCT2031220582, 2023-505189-26-00, U1111-1291-1987, MK-3475-06B, KEYMAKER-U06B, 2021-005443-76, 2023
Status last verified
Oct 2026
First submitted
1 Apr 2022
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Paclitaxel, Irinotecan and Pembrolizumab in people with Esophageal Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 58 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in China, Taiwan, Turkey (Türkiye), Italy, United States and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) During Safety Lead-in Phase (time frame: Up to approximately 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05319730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.

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