Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)

May 8, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 1/2 Open-Label, Umbrella Platform Design Study to Evaluate the Safety and Efficacy of Investigational Agents in Combination With Standard of Care Treatments as the Second-Line Treatment of Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma: Substudy 06D

This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a substudy of the master protocol MK-3475-U06 (KEYMAKER-U06).

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59062-000
        • Recruiting
        • Liga Norte Riograndense Contra o Câncer ( Site 8303)
        • Contact:
          • Study Coordinator
          • Phone Number: +558440095595
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceição ( Site 8301)
        • Contact:
          • Study Coordinator
          • Phone Number: +5551993590437
    • São Paulo
      • São Paulo, São Paulo, Brazil, 03102-002
        • Recruiting
        • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 8304)
        • Contact:
          • Study Coordinator
          • Phone Number: 551144500300
  • Chile
      • Antofagasta, Chile, 1263521
        • Recruiting
        • Bradford Hill Norte ( Site 8407)
        • Contact:
          • Study Coordinator
          • Phone Number: 56442023631
    • Los Lagos Region
      • Port Montt, Los Lagos Region, Chile, 5500243
        • Recruiting
        • Clínica Puerto Montt ( Site 8409)
        • Contact:
          • Study Coordinator
          • Phone Number: +56652484800
    • Maule Region
      • Talca, Maule Region, Chile, 3481349
        • Recruiting
        • Centro de Investigación del Maule ( Site 8408)
        • Contact:
          • Study Coordinator
          • Phone Number: 56712981241
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 8400)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224205098
      • Santiago, Region M. de Santiago, Chile, 7560908
        • Recruiting
        • Centro de Oncología de Precisión-Oncology ( Site 8404)
        • Contact:
          • Study Coordinator
          • Phone Number: 56225189885
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Recruiting
        • Clínica UC San Carlos de Apoquindo ( Site 8405)
        • Contact:
          • Study Coordinator
          • Phone Number: 56934271024
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 8401)
        • Contact:
          • Study Coordinator
          • Phone Number: 56229490970
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer hospital-Digestive Oncology ( Site 7500)
        • Contact:
          • Study Coordinator
          • Phone Number: (010)88196317
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Recruiting
        • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 7501)
        • Contact:
          • Study Coordinator
          • Phone Number: 0591-22859606
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated hospital of Xiamen University ( Site 7503)
        • Contact:
          • Study Coordinator
          • Phone Number: 0592-2139767
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Cancer Hospital ( Site 7504)
        • Contact:
          • Study Coordinator
          • Phone Number: 400-0371-818
    • Jiangxi
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • The First Affiliated Hospital of Nanchang University ( Site 7514)
        • Contact:
          • Study Coordinator
          • Phone Number: 0791-86427234
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center ( Site 7513)
        • Contact:
          • Study Coordinator
          • Phone Number: （021）6417 5590
    • Xinjiang
      • Ürümqi, Xinjiang, China, 841100
        • Recruiting
        • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 7506)
        • Contact:
          • Study Coordinator
          • Phone Number: (+86) 0991-7819113
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 7510)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571 8609 0073
  • France
    • Finistere
      • Brest, Finistere, France, 29200
        • Recruiting
        • Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi ( Site 7104)
        • Contact:
          • Study Coordinator
          • Phone Number: 33298223428
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • CIC. ( Site 7100)
        • Contact:
          • Study Coordinator
          • Phone Number: +33320445461
    • Île-de-France Region
      • Paris, Île-de-France Region, France, 75013
        • Recruiting
        • Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 7102)
        • Contact:
          • Study Coordinator
          • Phone Number: +331 42 16 10 41
  • Germany
      • Hamburg, Germany, 20249
        • Recruiting
        • Facharztzentrum Eppendorf-Facharztzentrum Eppendorf ( Site 8807)
        • Contact:
          • Study Coordinator
          • Phone Number: +4940360352246
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Recruiting
        • NCT-Department of Medical Oncology ( Site 8809)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 62215637784
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Recruiting
        • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 8802)
        • Contact:
          • Study Coordinator
          • Phone Number: +492118108751
  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Oncologia Medica ( Site 7202)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226437615
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 7207)
        • Contact:
          • Study Coordinator
          • Phone Number: 0543739100
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 7200)
        • Contact:
          • Study Coordinator
          • Phone Number: 0223903807
    • Tuscany
      • Pisa, Tuscany, Italy, 56126
        • Recruiting
        • Azienda Ospedaliero Universitaria Pisana ( Site 7206)
        • Contact:
          • Study Coordinator
          • Phone Number: 050992454
  • Norway
      • Oslo, Norway, 0379
        • Recruiting
        • Oslo universitetssykehus, Radiumhospitalet ( Site 8501)
        • Contact:
          • Study Coordinator
          • Phone Number: 4723026600
  • South Korea
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center-Department of Oncology ( Site 7901)
        • Contact:
          • Study Coordinator
          • Phone Number: +82230103217
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 7900)
        • Contact:
          • Study Coordinator
          • Phone Number: 82234101795
  • Switzerland
    • Canton of Geneva
      • Geneva, Canton of Geneva, Switzerland, 1211
        • Recruiting
        • Hôpitaux Universitaires de Genève (HUG) ( Site 8701)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 22 372 29 01
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Switzerland, 7000
        • Recruiting
        • Kantonsspital Graubünden-Medizin ( Site 8700)
        • Contact:
          • Study Coordinator
          • Phone Number: +41 81 256 61 11
  • Taiwan
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital ( Site 8007)
        • Contact:
          • Study Coordinator
          • Phone Number: 886422052121x15057
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 8001)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535x4559
      • Taipei, Taiwan, 10048
        • Recruiting
        • National Taiwan University Hospital-Oncology ( Site 8000)
        • Contact:
          • Study Coordinator
          • Phone Number: +88623123456x267852
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital ( Site 8005)
        • Contact:
          • Study Coordinator
          • Phone Number: +88628717270x131
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927)
        • Contact:
          • Study Coordinator
          • Phone Number: 520-621-2449
    • California
      • Los Angeles, California, United States, 90404
        • Recruiting
        • UCLA Hematology/Oncology - Santa Monica ( Site 8905)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-570-1453
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Completed
        • Norton Cancer Institute - Downtown ( Site 8900)
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • The Cancer and Hematology Centers ( Site 8912)
        • Contact:
          • Study Coordinator
          • Phone Number: 616-975-3065
    • New York
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Hematology-Oncology Associates of Central NY, P.C. ( Site 8925)
        • Contact:
          • Study Coordinator
          • Phone Number: 315-472-7504
      • New York, New York, United States, 10032
        • Completed
        • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center-UPMC ( Site 8904)
        • Contact:
          • Study Coordinator
          • Phone Number: 816-898-9413
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center ( Site 8920)
        • Contact:
          • Study Coordinator
          • Phone Number: 833-589-0868

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has histologically and/or cytologically confirmed diagnosis of previously treated, second line (2L) (received first line (1L) treatment) gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, or esophageal adenocarcinoma
  • Has metastatic disease or locally advanced, unresectable disease
  • Has experienced documented objective radiographic or clinical disease progression during or after 1L therapy containing any platinum/fluoropyrimidine doublet with or without immunotherapy
  • Tumor tissue must be confirmed as negative for HER2 expression (IHC 0/1+ or IHC2+/in situ hybridization negative) as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines
  • Can provide a core/excisional biopsy of a tumor lesion not previously irradiated (collected from a biopsy performed after the most recent systemic anticancer therapy regimen)
  • AEs due to previous anticancer therapies must be ≤Grade 1 or baseline (except alopecia and vitiligo). Endocrine-related AEs adequately treated with hormone replacement are acceptable
  • Has Eastern Cooperative Oncology Group performance status of 0 or 1
  • Has a life expectancy of at least 3 months
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to allocation/randomization
  • Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Human Immunodeficiency Virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has squamous cell or undifferentiated gastroesophageal cancer
  • Has experienced weight loss >20% over 3 months before the first dose of study intervention
  • 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 Grade ≥2 peripheral neuropathy
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
  • Has a serious or nonhealing wound or peptic ulcer or bone fracture within 28 days prior to allocation/randomization
  • Has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea)
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
  • Has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to allocation/randomization
  • Has uncontrolled arterial hypertension ≥150/≥90 mm mercury (Hg)
  • Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
  • Has undergone major surgery within 28 days prior to allocation/randomization, or central venous access device placement within 7 days prior to allocation/randomization or planned major surgery following initiation of study treatment
  • Is receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin or similar agents
  • Is receiving chronic therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents
  • Has a history of deep vein thrombosis, pulmonary embolism, or any other significant thromboembolism during the 3 months prior to allocation/randomization
  • Has significant bleeding disorders, vasculitis, or had a significant bleeding episode from the gastrointestinal (GI) tract within 3 months prior to study entry
  • Has history of GI perforation and/or fistulae within 6 months prior to allocation/randomization
  • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)- or HER3-targeted agent, topoisomerase 1 inhibitor-based ADC and/or a topoisomerase 1 inhibitor-based chemotherapy, or any previous systemic therapy targeting vascular endothelial growth factor (VEGF) or the vascular endothelial growth factor receptor (VEGFR) signaling pathways
  • Has received prior systemic anticancer therapy 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 received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has known additional malignancy that is progressing or has required active treatment within the past 3 years. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded
  • Has known active central nervous system metastases and/or carcinomatous meningitis
  • Has an active infection requiring systemic therapy
  • Has concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid) and Hepatitis C virus (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid) infection
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, or where suspected ILD or pneumonitis cannot be ruled out by imaging at screening
  • Has severe hypersensitivity (Grade ≥3) to MK-2870, or HER3-DXd, any of their excipients, and/or to another biologic therapy
  • Has not adequately recovered from major surgery or have ongoing surgical complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ramucirumab + Paclitaxel
Participants receive ramucirumab at 8mg/kg via intravenous (IV) infusion on days 1 and 15 of each 4-week cycle for up to ~60 weeks plus paclitaxel at 80 mg/M^2 via IV infusion on Days 1, 8, and 15 of each 4-week cycle (3 weeks on and 1 week off) until discontinuation.
Biological: Ramucirumab
8 mg/kg IV Infusion
Drug: Paclitaxel
80 mg/M^2 IV infusion
Experimental: Sacituzumab Tirumotecan + Paclitaxel
Following a 28-day run-in with sacituzumab tirumotecan at 3 mg/kg and 4 mg/kg IV infusion on Days 1 and 15 of a 6-week cycle plus paclitaxel at 80 mg/M^2 IV infusion on days 1, 8 and 15 of a 4-week cycle, participants receive paclitaxel at 80 mg/M^2 IV infusion on days 1, 8, 15 of each 4-week cycle (3 weeks on and 1 week off) plus sacituzumab tirumotecan at selected dose IV infusion on days 1, 15, 29 of every 6-week cycle until discontinuation.
Drug: Paclitaxel
80 mg/M^2 IV infusion
Biological: Sacituzumab Tirumotecan
3 mg/kg or 4 mg/kg IV Infusion
Other Names:
  • SKB264
  • MK-2870
  • sac-TMT
Drug: Rescue Medications
Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications for the Sacituzumab Tirumotecan + Paclitaxel arm include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent) and rescue medications for the HER3-DXd + ramucirumab arm include 5-HT3-receptor antagonist, NK-1 receptor antagonist, and corticosteroids.
Experimental: HER3-DXd + Ramucirumab
Participants receive HER3-DXd via IV infusion on days 1 and 22 of each 6-week cycle plus ramucirumab at 8mg/kg via IV infusion on days 1 and 15 and 29 of each 6-week cycle until discontinuation.
Biological: Ramucirumab
8 mg/kg IV Infusion
Biological: HER3-DXd
IV Infusion
Other Names:
  • U3-1402
  • MK-1022
  • patritumab deruxtecan
Drug: Rescue Medications
Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications for the Sacituzumab Tirumotecan + Paclitaxel arm include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent) and rescue medications for the HER3-DXd + ramucirumab arm include 5-HT3-receptor antagonist, NK-1 receptor antagonist, and corticosteroids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase
Time Frame: Up to ~28 days
DLTs are defined as any drug-related adverse event (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. The percentage of participants who experience at least one DLT will be presented.
Up to ~28 days
Percentage of Particiapants who Experience an Adverse Event (AE) During the Safety Lead-In Phase
Time Frame: Up to ~60 days
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 discontinued study intervention due to an AE will be presented.
Up to ~60 days
Percentage of Participants who Discontinue Study Intervention Due to an AE During the Safety Lead-In Phase
Time Frame: Up to ~28 days
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 discontinued study intervention due to an AE will be presented.
Up to ~28 days
Objective Response Rate (ORR)
Time Frame: Up to ~28 months
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.
Up to ~28 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to ~50 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by RECIST 1.1. 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.
Up to ~50 months
Duration of Response (DOR)
Time Frame: Up to ~50 months
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.
Up to ~50 months
Overall Survival (OS)
Time Frame: Up to ~50 months
OS is defined as the time from the date of randomization to the date of death from any cause. OS will be presented.
Up to ~50 months
Percentage of Particiapants who Experience an AE During the Efficacy Phase
Time Frame: Up to ~50 months
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 discontinued study intervention due to an AE will be presented.
Up to ~50 months
Percentage of Participants who Discontinue Study Intervention Due to an AE During the Efficacy Phase
Time Frame: Up to ~50 months
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 discontinued study intervention due to an AE will be presented.
Up to ~50 months
Incidence of sacituzumab tirumotecan anti-drug antibody (ADA)
Time Frame: Up to ~50 months
In participants treated with sacituzumab tirumotecan the immunogenicity of sacituzumab tirumotecan ADA response will be evaluated with validated immunogenicity assays.
Up to ~50 months
Incidence of HER3-DXd ADA
Time Frame: Up to ~50 months
In participants treated with HER3-DXd, the immunogenicity of HER3-DXd ADA response will be evaluated with validated immunogenicity assays.
Up to ~50 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Daiichi Sankyo

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2024

Primary Completion (Estimated)

May 9, 2028

Study Completion (Estimated)

August 8, 2030

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

May 31, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-06D
  • U1111-1299-8160 (Registry Identifier: UTN)
  • MK-3475-06D (Other Identifier: MSD)
  • 2023-509306-29-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Cancer

Clinical Trials on Ramucirumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uruguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe