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Gastroesophageal JunctionPhase 1/2NCT06445972

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

A Phase 1/2 study testing Ramucirumab, Paclitaxel and Sacituzumab Tirumotecan in people with Gastroesophageal Junction and Gastroesophageal Adenocarcinoma, run by Merck Sharp & Dohme LLC at 46 sites in 11 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, 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ramucirumab, Paclitaxel and Sacituzumab Tirumotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
46 sitesin 11 countries
Study dates
7 Aug 2024to 8 Aug 2030
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

  • 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)
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 31Show fewer
  • 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

Trial locations and contacts

46 sites in 11 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

46 sites in 11 countries

United States8 sites, 6 recruiting

  • Hematology-Oncology Associates of Central NY, P.C. ( Site 8925)

    East Syracuse, New York, 13057

    Study Coordinator, 315-472-7504

    Recruiting

  • The Cancer and Hematology Centers ( Site 8912)

    Grand Rapids, Michigan, 49503

    Study Coordinator, 616-975-3065

    Recruiting

  • University of Texas MD Anderson Cancer Center ( Site 8920)

    Houston, Texas, 77030

    Study Coordinator, 833-589-0868

    Recruiting

  • UCLA Hematology/Oncology - Santa Monica ( Site 8905)

    Los Angeles, California, 90404

    Study Coordinator, 310-570-1453

    Recruiting

  • Norton Cancer Institute - Downtown ( Site 8900)

    Louisville, Kentucky, 40202

    Completed

  • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907)

    New York, New York, 10032

    Completed

  • UPMC Hillman Cancer Center-UPMC ( Site 8904)

    Pittsburgh, Pennsylvania, 15232

    Study Coordinator, 816-898-9413

    Recruiting

  • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927)

    Tucson, Arizona, 85719

    Study Coordinator, 520-621-2449

    Recruiting

Other trials in United States

China8 sites, 8 recruiting

  • Beijing Cancer hospital-Digestive Oncology ( Site 7500)

    Beijing, Beijing Municipality, 100142

    Study Coordinator, (010)88196317

    Recruiting

  • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 7501)

    Fuzhou, Fujian, 350025

    Study Coordinator, 0591-22859606

    Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 7510)

    Hangzhou, Zhejiang, 310016

    Study Coordinator, 0571 8609 0073

    Recruiting

  • The First Affiliated Hospital of Nanchang University ( Site 7514)

    Nanchang, Jiangxi, 330000

    Study Coordinator, 0791-86427234

    Recruiting

  • Fudan University Shanghai Cancer Center ( Site 7513)

    Shanghai, Shanghai Municipality, 200032

    Study Coordinator, （021）6417 5590

    Recruiting

  • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 7506)

    Ürümqi, Xinjiang, 841100

    Study Coordinator, (+86) 0991-7819113

    Recruiting

  • The First Affiliated hospital of Xiamen University ( Site 7503)

    Xiamen, Fujian, 361003

    Study Coordinator, 0592-2139767

    Recruiting

  • Henan Cancer Hospital ( Site 7504)

    Zhengzhou, Henan, 450000

    Study Coordinator, 400-0371-818

    Recruiting

Other trials in China

Chile7 sites, 7 recruiting

  • Bradford Hill Norte ( Site 8407)

    Antofagasta, 1263521

    Study Coordinator, 56442023631

    Recruiting

  • Clínica Puerto Montt ( Site 8409)

    Port Montt, Los Lagos Region, 5500243

    Study Coordinator, +56652484800

    Recruiting

  • FALP-UIDO ( Site 8400)

    Santiago, Region M. de Santiago, 7500921

    Study Coordinator, 56224205098

    Recruiting

  • Centro de Oncología de Precisión-Oncology ( Site 8404)

    Santiago, Region M. de Santiago, 7560908

    Study Coordinator, 56225189885

    Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 8405)

    Santiago, Region M. de Santiago, 7620002

    Study Coordinator, 56934271024

    Recruiting

  • Bradfordhill-Clinical Area ( Site 8401)

    Santiago, Region M. de Santiago, 8420383

    Study Coordinator, 56229490970

    Recruiting

  • Centro de Investigación del Maule ( Site 8408)

    Talca, Maule Region, 3481349

    Study Coordinator, 56712981241

    Recruiting

Other trials in Chile

Brazil4 sites, 4 recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 8303)

    Natal, Rio Grande do Norte, 59062-000

    Study Coordinator, +558440095595

    Recruiting

  • Hospital Nossa Senhora da Conceição ( Site 8301)

    Porto Alegre, Rio Grande do Sul, 91350-200

    Study Coordinator, +5551993590437

    Recruiting

  • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 8304)

    São Paulo, São Paulo, 03102-002

    Study Coordinator, 551144500300

    Recruiting

  • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 8300)

    São Paulo, 01246-000

    Study Coordinator, 551138932000

    Recruiting

Other trials in Brazil

Italy4 sites, 4 recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 7207)

    Meldola, Emilia-Romagna, 47014

    Study Coordinator, 0543739100

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 7200)

    Milan, Lombardy, 20133

    Study Coordinator, 0223903807

    Recruiting

  • Ospedale San Raffaele-Oncologia Medica ( Site 7202)

    Milan, 20132

    Study Coordinator, +390226437615

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana ( Site 7206)

    Pisa, Tuscany, 56126

    Study Coordinator, 050992454

    Recruiting

Other trials in Italy

Taiwan4 sites, 4 recruiting

  • China Medical University Hospital ( Site 8007)

    Taichung, 404332

    Study Coordinator, 886422052121x15057

    Recruiting

  • National Cheng Kung University Hospital ( Site 8001)

    Tainan, 704

    Study Coordinator, +88662353535x4559

    Recruiting

  • National Taiwan University Hospital-Oncology ( Site 8000)

    Taipei, 10048

    Study Coordinator, +88623123456x267852

    Recruiting

  • Taipei Veterans General Hospital ( Site 8005)

    Taipei, 112

    Study Coordinator, +88628717270x131

    Recruiting

Other trials in Taiwan

France3 sites, 3 recruiting

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi ( Site 7104)

    Brest, Finistere, 29200

    Study Coordinator, 33298223428

    Recruiting

  • CIC. ( Site 7100)

    Lille, Nord, 59037

    Study Coordinator, +33320445461

    Recruiting

  • Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 7102)

    Paris, Île-de-France Region, 75013

    Study Coordinator, +331 42 16 10 41

    Recruiting

Other trials in France

Germany3 sites, 3 recruiting

  • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 8802)

    Düsseldorf, North Rhine-Westphalia, 40225

    Study Coordinator, +492118108751

    Recruiting

  • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 8807)

    Erdgeschoss, Free and Hanseatic City of Hamburg, 22297

    Study Coordinator, +4940360352246

    Recruiting

  • NCT-Department of Medical Oncology ( Site 8809)

    Heidelberg, Baden-Wurttemberg, 69120

    Study Coordinator, +49 62215637784

    Recruiting

Other trials in Germany

South Korea2 sites, 2 recruiting

  • Asan Medical Center-Department of Oncology ( Site 7901)

    Seoul, 05505

    Study Coordinator, +82230103217

    Recruiting

  • Samsung Medical Center-Division of Hematology/Oncology ( Site 7900)

    Seoul, 06351

    Study Coordinator, 82234101795

    Recruiting

Other trials in South Korea

Switzerland2 sites, 2 recruiting

  • Kantonsspital Graubünden-Medizin ( Site 8700)

    Chur, Kanton Graubünden, 7000

    Study Coordinator, +41 81 256 61 11

    Recruiting

  • Hôpitaux Universitaires de Genève (HUG) ( Site 8701)

    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 8501)

    Oslo, 0379

    Study Coordinator, 4723026600

    Recruiting

Other trials in Norway

About this study

Official title: 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.

Read the detailed description

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

Being tested
Ramucirumab, Paclitaxel, Sacituzumab Tirumotecan, Rescue Medications, HER3-DXd
Keywords
Programmed Cell Death 1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Medical subject headings
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.

  • RamucirumabBiological

    8 mg/kg IV Infusion

  • PaclitaxelDrug

    80 mg/M^2 IV infusion

  • Sacituzumab TirumotecanBiological

    Also called MK-2870, SKB264, sac-TMT

    3 mg/kg or 4 mg/kg IV Infusion

  • Rescue MedicationsDrug

    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.

  • HER3-DXdBiological

    Also called patritumab deruxtecan, MK-1022, U3-1402

    IV Infusion

Study groups in NCT06445972
Study groupRoleWhat they receive
Ramucirumab + PaclitaxelActive comparatorParticipants 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.
Receives: Biological: Ramucirumab; Drug: Paclitaxel
Sacituzumab Tirumotecan + PaclitaxelExperimentalFollowing 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.
Receives: Drug: Paclitaxel; Biological: Sacituzumab Tirumotecan; Drug: Rescue Medications
HER3-DXd + RamucirumabExperimentalParticipants 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.
Receives: Biological: Ramucirumab; Drug: Rescue Medications; Biological: HER3-DXd

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

    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.

    Measured: Up to ~28 days

  2. Percentage of Particiapants who Experience an Adverse Event (AE) During the 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. The percentage of participants who discontinued study intervention due to an AE will be presented.

    Measured: Up to ~60 days

  3. Percentage of Participants who Discontinue Study Intervention Due to an AE During the 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. The percentage of participants who discontinued study intervention due to an AE will be presented.

    Measured: Up to ~28 days

  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 ~28 months

Secondary outcomes (7)

  1. Progression Free Survival (PFS)

    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.

    Measured: Up to ~50 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 ~50 months

  3. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death from any cause. OS will be presented.

    Measured: Up to ~50 months

  4. Percentage of Particiapants who Experience 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. The percentage of participants who discontinued study intervention due to an AE will be presented.

    Measured: Up to ~50 months

  5. Percentage of Participants who Discontinue Study Intervention 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. The percentage of participants who discontinued study intervention due to an AE will be presented.

    Measured: Up to ~50 months

  6. Incidence of sacituzumab tirumotecan anti-drug antibody (ADA)

    In participants treated with sacituzumab tirumotecan the immunogenicity of sacituzumab tirumotecan ADA response will be evaluated with validated immunogenicity assays.

    Measured: Up to ~50 months

  7. Incidence of HER3-DXd ADA

    In participants treated with HER3-DXd, the immunogenicity of HER3-DXd ADA response will be evaluated with validated immunogenicity assays.

    Measured: Up to ~50 months

Timeline

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

  1. First posted6 Jun 2024
  2. Study start7 Aug 2024
  3. Primary completion9 May 2028 (estimated)
  4. Study completion8 Aug 2030 (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
Single blind
Who is masked
Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06445972
Sponsor's protocol ID
3475-06D
Other IDs
2023-509306-29-00, U1111-1299-8160, MK-3475-06D, 2023
Status last verified
Sep 2026
First submitted
31 May 2024
Last updated
3 Sep 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 Ramucirumab, Paclitaxel and Sacituzumab Tirumotecan in people with Gastroesophageal Junction and Gastroesophageal Adenocarcinoma, run by Merck Sharp & Dohme LLC at 46 sites in 11 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 12 inclusion and 31 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, China, Chile, Brazil, Italy and 6 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?

Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase (time frame: Up to ~28 days). 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 NCT06445972.

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 3 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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