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Esophageal Squamous Cell CarcinomaPhase 1/2NCT06780111

Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)

A Phase 1/2 study testing Pembrolizumab, I-DXd and Leucovorin in people with Esophageal Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 50 sites in 16 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

Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. 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?
Pembrolizumab, I-DXd and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
298 participants
Where
50 sitesin 16 countries
Study dates
30 Jul 2025to 4 Jan 2032
Phase
Phase 1/2

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

  • The main inclusion criteria include but are not limited to the following:
  • Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting.
  • Has measurable disease per RECIST 1.1 as assessed by the local site. investigator or designee/radiology assessment and verified by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
  • Has had AEs due to previous anticancer therapies that have recovered to ≤Grade 1 or baseline. Endocrine-related AEs that are adequately treated with hormone replacement are elegible.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Has adequate organ function.

Who cannot join

  • The main exclusion criteria include but are not limited to the following:
  • Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer.
  • Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula.
  • Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
  • Has clinically significant corneal disease, history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
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  • Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.
  • Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • Has inadequate cardiac function assessed as by a corrected QT interval by Fredericia (QTcF) value ≥470 msec.
  • Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.
  • Has peripheral neuropathy ≥ Grade 2.
  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has had a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), has a current diagnosis of ILD, or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out.
  • Has active infection requiring systemic therapy.
  • Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder.

Trial locations and contacts

50 sites in 16 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

50 sites in 16 countries

Taiwan7 sites, 7 recruiting

  • Kaohsiung Chang Gung Memorial Hospital ( Site 1003)

    Kaohsiung City, 83301

    Study Coordinator, +88677317123x3679

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1009)

    Kaoshiung, Kaohsiung, 807

    Study Coordinator, +8867-3121101#7451

    Recruiting

  • China Medical University Hospital ( Site 1007)

    Taichung, 40707

    Study Coordinator, 886-4-22052121

    Recruiting

  • National Cheng Kung University Hospital ( Site 1001)

    Tainan, 704302

    Study Coordinator, +88662353535x4559

    Recruiting

  • National Taiwan University Hospital ( Site 1000)

    Taipei, 100225

    Study Coordinator, +886223123456x67680

    Recruiting

  • Taipei Veterans General Hospital ( Site 1005)

    Taipei, 11217

    Study Coordinator, +886228712121

    Recruiting

  • Chang Gung Memorial Hospital - Linkou Branch ( Site 1006)

    Taoyuan, 33305

    Study Coordinator, +88633281200 #8825

    Recruiting

Other trials in Taiwan

Chile6 sites, 6 recruiting

  • Bradford Hill Norte ( Site 1405)

    Antofagasta, 1263521

    Study Coordinator, +56442023631

    Recruiting

  • Clínica Puerto Montt ( Site 1406)

    Port Montt, Los Lagos Region, 5500243

    Study Coordinator, +56652484800

    Recruiting

  • Fundación Arturo López Pérez ( Site 1400)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, +56224205098

    Recruiting

  • Centro de Oncología de Precisión ( Site 1402)

    Santiago, Region M. de Santiago, 7560913

    Study Coordinator, +56972151681

    Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 1403)

    Santiago, Region M. de Santiago, 7620002

    Study Coordinator, +56223748924

    Recruiting

  • Bradfordhill ( Site 1401)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, +56220490970

    Recruiting

Other trials in Chile

China6 sites, 6 recruiting

  • Beijing Cancer Hospital ( Site 9500)

    Beijing, Beijing Municipality, 130021

    Study Coordinator, (010)88196317

    Recruiting

  • The Second Affiliated Hospital of Anhui Medical University ( Site 9511)

    Hefei, Anhui, 230601

    Study Coordinator, 0551-63839536

    Recruiting

  • The First Affiliated Hospital of Nanchang University ( Site 9505)

    Nanchang, Jiangxi, 330006

    Study Coordinator, 86079188692201

    Recruiting

  • The First Affiliated Hospital of Xiamen University ( Site 9503)

    Xiamen, Fujian, 361003

    Study Coordinator, 0592-2139767

    Recruiting

  • Xuzhou Central Hospital ( Site 9512)

    Xuzhou, Jiangsu, 221000

    Study Coordinator, 86051680812397

    Recruiting

  • Henan Cancer Hospital ( Site 9509)

    Zhengzhou, Henan, 450008

    Study Coordinator, 0371-65587625

    Recruiting

Other trials in China

Brazil4 sites, 4 recruiting

  • Liga Norte Riograndense Contra o Cancer ( Site 1301)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +55 84 4009-5595

    Recruiting

  • Hospital Nossa Senhora da Conceicao ( Site 1300)

    Porto Alegre, Rio Grande do Sul, 91010-004

    Study Coordinator, +555133572092

    Recruiting

  • IBCC - Instituto Brasileiro de Controle do Cancer ( Site 1303)

    São Paulo, São Paulo, 03102-002

    Study Coordinator, 551144500300

    Recruiting

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1302)

    São Paulo, 01246-000

    Study Coordinator, 551138932000

    Recruiting

Other trials in Brazil

Germany4 sites, 4 recruiting

  • Universitätsklinikum Carl Gustav Carus - Medical Oncology ( Site 1806)

    Dresden, Saxony, 01307

    Study Coordinator, +493514583016

    Recruiting

  • Universitaetsklinikum Duesseldorf ( Site 1808)

    Düsseldorf, North Rhine-Westphalia, 40225

    Study Coordinator, +492118108751

    Recruiting

  • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 1807)

    Erdgeschoss, Free and Hanseatic City of Hamburg, 22297

    Study Coordinator, +4940360352246

    Recruiting

  • NCT-Department of Medical Oncology ( Site 1809)

    Heidelberg, Baden-Wurttemberg, 69120

    Study Coordinator, +49 62215637784

    Recruiting

Other trials in Germany

Turkey (Türkiye)4 sites, 4 recruiting

  • Hacettepe Universite Hastaneleri ( Site 9401)

    Ankara, 06230

    Study Coordinator, +905333319240

    Recruiting

  • Memorial Ankara Hastanesi ( Site 9406)

    Ankara, 06520

    Study Coordinator, +905456177189

    Recruiting

  • Ankara Bilkent Şehir Hastanesi ( Site 9403)

    Ankara, 06800

    Study Coordinator, +90 312 552 60 00

    Recruiting

  • Atatürk Üniversitesi ( Site 9405)

    Erzurum, 25070

    Study Coordinator, +905543701653

    Recruiting

Other trials in Turkey (Türkiye)

France3 sites, 3 recruiting

  • C.H.R.U. de Brest - Hopital Cavale Blanche ( Site 9104)

    Brest, Finistere, 29609

    Study Coordinator, 33298223428

    Recruiting

  • CHU Lille - Institut Coeur Poumon ( Site 9100)

    Lille, Nord, 59037

    Study Coordinator, +33320445461

    Recruiting

  • Pitie Salpetriere University Hospital ( Site 9102)

    Paris, 75013

    Study Coordinator, +331 42 16 10 41

    Recruiting

Other trials in France

Japan3 sites, 3 recruiting

  • National Cancer Center Hospital ( Site 9700)

    Chūō, Tokyo, 104-0045

    Study Coordinator, +81-3-3542-2511

    Recruiting

  • National Cancer Center Hospital East ( Site 9701)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • Aichi Cancer Center ( Site 9702)

    Nagoya, Aichi-ken, 464-8681

    Study Coordinator, +81-52-762-6111

    Recruiting

Other trials in Japan

South Korea3 sites, 3 recruiting

  • National Cancer Center ( Site 9902)

    Goyang-si, Kyonggi-do, 10408

    Study Coordinator, +82319201694

    Recruiting

  • Asan Medical Center ( Site 9901)

    Seoul, 05505

    Study Coordinator, +82230107179

    Recruiting

  • Samsung Medical Center ( Site 9900)

    Seoul, 06351

    Study Coordinator, +82234106518

    Recruiting

Other trials in South Korea

Italy2 sites, 2 recruiting

  • Ospedale San Raffaele-Oncologia Medica ( Site 9201)

    Milan, Lombardy, 20132

    Study Coordinator, +390226437615

    Recruiting

  • Istituto Oncologico Veneto IRCCS ( Site 9202)

    Padova, Veneto, 35128

    Study Coordinator, 390498215910

    Recruiting

Other trials in Italy

Switzerland2 sites, 2 recruiting

  • Kantonsspital Graubuenden ( Site 1700)

    Chur, Kanton Graubünden, 7000

    Study Coordinator, +41 81 256 61 11

    Recruiting

  • Hopitaux Universitaires de Geneve HUG. ( Site 1701)

    Geneva, 1211

    Study Coordinator, +41 (0)22 372 95 77

    Recruiting

Other trials in Switzerland

Thailand2 sites, 2 recruiting

  • Songklanagarind hospital ( Site 1101)

    Hat Yai, Changwat Songkhla, 90110

    Study Coordinator, +6674451469

    Recruiting

  • Ramathibodi Hospital ( Site 1103)

    Ratchathewi, Bangkok, 10400

    Study Coordinator, +6622004029

    Recruiting

Other trials in Thailand

United States1 site, 1 recruiting

  • UPMC Hillman Cancer Center ( Site 1904)

    Pittsburgh, Pennsylvania, 15232

    Study Coordinator, 412-623-8974

    Recruiting

Other trials in United States

Czechia1 site, 1 recruiting

  • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 9000)

    Brno, Brno-mesto, 656 53

    Study Coordinator, +420543136812

    Recruiting

Other trials in Czechia

Norway1 site, 1 recruiting

  • Oslo Universitetssykehus Radiumhospitalet ( Site 1501)

    Oslo, 0379

    Study Coordinator, +4723026600

    Recruiting

Other trials in Norway

Singapore1 site, 1 recruiting

  • National University Hospital ( Site 9800)

    Singapore, Central Singapore, 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 in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E

Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts.

Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing.

Read more

Researchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.

The main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.

Read the detailed description

The master protocol is MK-3475-U06.

Being tested
Pembrolizumab, I-DXd, Leucovorin, Levoleucovorin, 5-Fluorouracil (5-FU)
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    IV infusion

  • I-DXdBiological

    Also called Ifinatamab deruxtecan, MK-2400, DS-7300a

    IV infusion

  • LeucovorinDrug

    IV infusion

  • LevoleucovorinDrug

    IV infusion

  • 5-Fluorouracil (5-FU)Drug

    IV Infusion

  • OxaliplatinDrug

    IV infusion

  • Sacituzumab tirumotecanBiological

    Also called MK-2870, SKB264

    IV infusion

  • Rescue MedicationDrug

    Includes 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid for Arms 2, 3, and 4, and H1 receptor antagonist, H2 receptor antagonist, acetaminophen, dexamethasone, and steroid mouthwash for Arm 5, administered per approved product label

Study groups in NCT06780111
Study groupRoleWhat they receive
Pembrolizumab + ChemotherapyActive comparatorParticipants will receive 400 mg of pembrolizumab via intravenous (IV) infusion every six weeks (Q6W) on Day 1 of each 42-day cycle up to 18 cycles (up to approximately 2 years), and mFOLFOX6 chemotherapy: oxaliplatin 85 mg/m^2 via IV infusion every 2 weeks (Q2W), until progressive disease (PD) or toxicity; leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity; 5-fluorouracil (5-FU) 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity.
Receives: Biological: Pembrolizumab; Drug: Leucovorin; Drug: Levoleucovorin; Drug: 5-Fluorouracil (5-FU); Drug: Oxaliplatin
Pembrolizumab + I-DXdExperimentalParticipants will receive 200 mg of pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Participants will also receive up to 12 mg/kg I-XDd Q3W via IV infusion, until PD or toxicity.
Receives: Biological: Pembrolizumab; Biological: I-DXd; Drug: Rescue Medication
Pembrolizumab + I-DXd + 5-FU IV + Leucovorin or LevoleucovorinExperimentalParticipants will receive 200 mg pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle up to 35 cycles (up to approximately 2 years). Participants will also receive I-DXd up to 12 mg/kg via IV infusion Q3W, until PD or toxicity; 5-FU 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, OR 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity.
Receives: Biological: Pembrolizumab; Biological: I-DXd; Drug: Leucovorin; Drug: Levoleucovorin; Drug: 5-Fluorouracil (5-FU); Drug: Rescue Medication
Pembrolizumab + I-DXd + 5-FU IV + Leucovorin or Levoleucovorin + OxaliplatinExperimentalParticipants will receive 200 mg of pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle up to 35 cycles (up to approximately 2 years). Participants will also receive up to 12 mg/kg I-DXd via IV infusion q3w, until PD or toxicity; 5-FU 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; 60mg/m^2 oxaliplatin via IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity.
Receives: Biological: Pembrolizumab; Biological: I-DXd; Drug: Leucovorin; Drug: Levoleucovorin; Drug: 5-Fluorouracil (5-FU); Drug: Oxaliplatin; Drug: Rescue Medication
Pembrolizumab + Sacituzumab tirumotecan + 5-FU IV + Leucovorin or LevoleucovorinExperimentalParticipants will receive 400 mg pembrolizumab via IV infusion Q6W on Day 1 of each 42-day cycle up to 18 cycles (up to approximately 2 years). Participants will also receive sacituzumab tirumotecan 4 mg/kg via IV infusion Days 1, 15, and 29 every 42-day cycle, until PD or toxicity; 5-FU 400 mg/m^2 bolus IV infusion followed by 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, OR 2400 mg/m^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 via IV infusion Q2W, until PD or toxicity.
Receives: Biological: Pembrolizumab; Drug: Leucovorin; Drug: Levoleucovorin; Drug: 5-Fluorouracil (5-FU); Biological: Sacituzumab tirumotecan; Drug: Rescue Medication

What is being measured

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

  1. Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase

    Percentage of participants experiencing toxicities that are possibly, probably, or definitely related to study intervention; that meet pre-defined severity criteria; and result in a change in the given dose.

    Measured: Up to approximately 28 days

  2. Percentage of Participants who Experience an Adverse Event (AE)

    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. The percentage of participants who experience an AE will be reported.

    Measured: Up to approximately 77 months

  3. Objective Response Rate (ORR)

    ORR is defined as a confirmed complete response (CR: the 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 (RECIST) 1.1 as assessed by blinded independent central review (BICR). The percentage of participants who experience CR or PR as assessed by BICR will be presented.

    Measured: Up to approximately 77 months

Secondary outcomes (10)

  1. 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 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 77 months

  2. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death from any cause, whichever occurs first. 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. PFS as assessed by BICR will be presented.

    Measured: Up to approximately 77 months

  3. Overall Survival (OS)

    OS is defined as the time from allocation/randomization to death due to any cause.

    Measured: Up to approximately 77 months

  4. Disease Control Rate (DCR)

    DCR is defined as a confirmed complete response (CR) or partial response (PR), or stable disease (SD) with at least 6 months PFS per RECIST 1.1 as assessed by BICR.

    Measured: Up to approximately 77 months

  5. Maximum Plasma Concentration (Cmax) of I-DXd

    Cmax is defined as the peak level I-DXd reaches in the blood plasma. Blood samples collected predose and at multiple timepoints postdose will be used to determine the Cmax of I-DXd when co-administered with other investigational agents.

    Measured: At designated time points up to approximately 65 months

  6. Time to Maximum Plasma Concentration (Tmax) of I-DXd

    Tmax is defined as the time it took I-DXd to reach its peak level in blood plasma. Blood samples collected predose and at designated timepoints postdose will be used to determine the Tmax of I-DXd when co-administered with other investigational agents.

    Measured: At designated time points up to approximately 65 months

  7. Area Under the Concentration-Time Curve from Time 0 to Last Measurable Plasma Concentration (AUClast) of I-DXd

    AUClast is defined as the area under the concentration-time curve from time 0 to the last measurable concentration of I-DXd in the blood plasma. Blood samples collected at predose and at designated timepoints postdose will be used to determine the AUClast of I-DXd in combination with other agents.

    Measured: At designated time points up to approximately 65 months

  8. Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Period (AUCtau) of I-DXd

    AUCtau is defined as the area under the concentration-time curve from time zero to the end of the dosing period. Blood samples collected at predose and at designated timepoints postdose will be used to determine the AUCtau of I-DXd in combination with other agents.

    Measured: At designated time points up to approximately 65 months

  9. The Percentage of Participants with Antidrug Antibodies (ADA) Against I-DXd

    Blood samples collected at designated timepoints will be used to determine the ADA response to I-DXd. The percentage of participants with ADA will be reported.

    Measured: Up to approximately 65 months

  10. The Percentage of Participants with Treatment-Emergent ADA Against I-DXd

    Blood samples collected at designated timepoints will be used to determine the treatment-emergent ADA response to I-DXd. The percentage of participants who have treatment-emergent I-DXd ADA will be reported.

    Measured: Up to approximately 65 months

Timeline

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

  1. First posted17 Jan 2025
  2. Study start30 Jul 2025
  3. Primary completion4 Jan 2032 (estimated)
  4. Study completion4 Jan 2032 (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
298 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06780111
Sponsor's protocol ID
3475-06E
Other IDs
MK-3475-06E, 2024-514273-22-00, U1111-1307-6484, jRCT2041240166
Status last verified
Oct 2026
First submitted
13 Jan 2025
Last updated
16 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

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