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Badanie cząstkowe 06C: Badanie dotyczące stosowania sacituzumabu tirumotekanu (MK-2870) z pembrolizumabem (MK-3475) i chemioterapii u pacjentów z miejscowo zaawansowanym, nieresekcyjnym/przerzutowym gruczolakorakiem żołądka pierwszego rzutu (MK-3475-06C/KEYMAKER-U06)

12 listopada 2026 zaktualizowane przez: Merck Sharp & Dohme LLC

Otwarte badanie fazy 1/2 z platformą parasolową dotyczące stosowania MK-2870 z pembrolizumabem (MK-3475) i chemioterapii u uczestników z miejscowo zaawansowanym, nieresekcyjnym/przerzutowym gruczolakorakiem żołądka o pojemności 1 l (gruczolakorak żołądka, gruczolakorak połączenia żołądkowo-przełykowego i gruczolakorak przełyku): Badanie dodatkowe 06C

This is a phase 1/2, multicenter, open-label umbrella platform study that will evaluate the safety and tolerability of investigational agents with pembrolizumab and fluoropyrimidine chemotherapy for the first-line (1L) treatment of participants with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric, gastroesophageal junction, or esophageal adenocarcinoma.

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to evaluate the safety and tolerability, and to establish a recommended Phase 2 dose (RP2D) for investigational agents in combination with chemotherapy and immunotherapy. There is no formal hypothesis in this study.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

The master protocol is MK-3475-U06.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

160

Faza

  • Faza 2
  • Faza 1

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Brazylia
      • São Paulo, Brazylia, 03102-006
        • Rekrutacyjny
        • IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 551144500300
      • São Paulo, Brazylia, 01246-000
        • Rekrutacyjny
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 551138932000
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazylia, 59062-000
        • Rekrutacyjny
        • Liga Norte Riograndense Contra o Câncer ( Site 6303)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +558440095595
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazylia, 91350-200
        • Rekrutacyjny
        • Hospital Nossa Senhora da Conceição ( Site 6301)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +5551993590437
  • Chile
      • Antofagasta, Chile, 1263521
        • Rekrutacyjny
        • Bradford Hill Norte ( Site 6407)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 56442023631
    • Los Lagos Region
      • Port Montt, Los Lagos Region, Chile, 5500243
        • Rekrutacyjny
        • Clínica Puerto Montt ( Site 6409)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 56961687093
    • Maule Region
      • Talca, Maule Region, Chile, 3481349
        • Zakończony
        • Centro de Investigación del Maule ( Site 6408)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • Rekrutacyjny
        • FALP-UIDO ( Site 6400)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 56224205098
      • Santiago, Region M. de Santiago, Chile, 7560908
        • Rekrutacyjny
        • Centro de Oncología de Precisión-Oncology ( Site 6404)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 56225189885
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Rekrutacyjny
        • Clínica UC San Carlos de Apoquindo ( Site 6405)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 56934271024
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Rekrutacyjny
        • Bradfordhill-Clinical Area ( Site 6401)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 56229490970
  • Chiny
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny, 100142
        • Rekrutacyjny
        • Beijing Cancer hospital-Digestive Oncology ( Site 5500)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: (010)88196317
    • Fujian
      • Fuzhou, Fujian, Chiny, 350025
        • Rekrutacyjny
        • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 0591-22859606
      • Xiamen, Fujian, Chiny, 361003
        • Rekrutacyjny
        • The First Affiliated hospital of Xiamen University ( Site 5503)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 0592-2139767
    • Henan
      • Zhengzhou, Henan, Chiny, 450008
        • Rekrutacyjny
        • Henan Cancer Hospital ( Site 5504)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 400-0371-818
    • Jiangxi
      • Nanchang, Jiangxi, Chiny, 330000
        • Rekrutacyjny
        • The First Affiliated Hospital of Nanchang University ( Site 5514)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 0791-86427234
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chiny, 200032
        • Aktywny, nie rekrutujący
        • Fudan University Shanghai Cancer Center ( Site 5513)
    • Xinjiang
      • Ürümqi, Xinjiang, Chiny, 841100
        • Aktywny, nie rekrutujący
        • Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)
    • Zhejiang
      • Hangzhou, Zhejiang, Chiny, 310016
        • Rekrutacyjny
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 0571 8609 0073
  • Francja
    • Finistere
      • Brest, Finistere, Francja, 29200
        • Rekrutacyjny
        • CHU-BREST Cavale Blanche ( Site 5104)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 33298223428
    • Nord
      • Lille, Nord, Francja, 59037
        • Rekrutacyjny
        • CIC. ( Site 5100)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +33320445461
    • Île-de-France Region
      • Paris, Île-de-France Region, Francja, 75013
        • Rekrutacyjny
        • Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +331 42 16 10 41
  • Korea Południowa
      • Seoul, Korea Południowa, 05505
        • Rekrutacyjny
        • Asan Medical Center-Department of Oncology ( Site 5901)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +82230103217
      • Seoul, Korea Południowa, 06351
        • Rekrutacyjny
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 82234101795
  • Niemcy
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Niemcy, 69120
        • Rekrutacyjny
        • NCT-Department of Medical Oncology ( Site 6809)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +49 62215637784
    • Free and Hanseatic City of Hamburg
      • Erdgeschoss, Free and Hanseatic City of Hamburg, Niemcy, 22297
        • Rekrutacyjny
        • HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 6807)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: + 4940360352246
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Niemcy, 40225
        • Zakończony
        • Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)
  • Norwegia
      • Oslo, Norwegia, 0379
        • Rekrutacyjny
        • Oslo universitetssykehus, Radiumhospitalet ( Site 6501)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 4723026600
  • Stany Zjednoczone
    • Arizona
      • Tucson, Arizona, Stany Zjednoczone, 85719
        • Rekrutacyjny
        • University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 520-621-2449
    • California
      • Los Angeles, California, Stany Zjednoczone, 90404
        • Rekrutacyjny
        • UCLA Hematology/Oncology - Santa Monica ( Site 6905)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 310-570-1453
    • Kentucky
      • Louisville, Kentucky, Stany Zjednoczone, 40202
        • Zakończony
        • Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)
    • Michigan
      • Grand Rapids, Michigan, Stany Zjednoczone, 49503
        • Rekrutacyjny
        • The Cancer and Hematology Centers ( Site 6912)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 616-975-3065
    • New York
      • East Syracuse, New York, Stany Zjednoczone, 13057
        • Rekrutacyjny
        • Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 315-472-7504
      • New York, New York, Stany Zjednoczone, 10032
        • Zakończony
        • Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stany Zjednoczone, 15232
        • Rekrutacyjny
        • UPMC Hillman Cancer Center-UPMC ( Site 6904)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 816-898-9413
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77030
        • Rekrutacyjny
        • University of Texas MD Anderson Cancer Center ( Site 6920)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 833-589-0868
  • Szwajcaria
    • Canton of Geneva
      • Geneva, Canton of Geneva, Szwajcaria, 1211
        • Rekrutacyjny
        • Hôpitaux Universitaires de Genève (HUG) ( Site 6701)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +41 22 372 29 01
    • Kanton Graubünden
      • Chur, Kanton Graubünden, Szwajcaria, 7000
        • Rekrutacyjny
        • Kantonsspital Graubünden-Medizin ( Site 6700)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +41 81 256 61 11
  • Tajlandia
    • Bangkok
      • Bangkoknoi, Bangkok, Tajlandia, 10700
        • Rekrutacyjny
        • Faculty of Medicine Siriraj Hospital ( Site 6102)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +6624194489
      • Pathumwan, Bangkok, Tajlandia, 10330
        • Rekrutacyjny
        • Chulalongkorn Hospital ( Site 6104)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 022564533
      • Ratchathewi, Bangkok, Tajlandia, 10400
        • Rekrutacyjny
        • Ramathibodi Hospital ( Site 6103)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 022011671
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Tajlandia, 90110
        • Rekrutacyjny
        • Songklanagarind hospital ( Site 6101)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +6674451469
  • Tajwan
      • Taichung, Tajwan, 404
        • Rekrutacyjny
        • China Medical University Hospital ( Site 6007)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 886422052121x15057
      • Tainan, Tajwan, 704
        • Rekrutacyjny
        • National Cheng Kung University Hospital ( Site 6001)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +88662353535x4559
      • Taipei, Tajwan, 10048
        • Rekrutacyjny
        • National Taiwan University Hospital-Oncology ( Site 6000)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +88623123456x267852
      • Taipei, Tajwan, 112
        • Rekrutacyjny
        • Taipei Veterans General Hospital ( Site 6005)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +88628717270x131
  • Włochy
      • Milan, Włochy, 20132
        • Rekrutacyjny
        • Ospedale San Raffaele-Oncologia Medica ( Site 5202)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: +390226437615
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Włochy, 47014
        • Rekrutacyjny
        • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 5207)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 0543739100
    • Lombardy
      • Milan, Lombardy, Włochy, 20133
        • Rekrutacyjny
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 0223903807
    • Tuscany
      • Pisa, Tuscany, Włochy, 56126
        • Rekrutacyjny
        • Azienda Ospedaliero Universitaria Pisana ( Site 5206)
        • Kontakt:
          • Study Coordinator
          • Numer telefonu: 050992454

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

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

  • Has histologically and/or cytologically confirmed diagnosis of previously untreated locally advanced unresectable or metastatic first-line (1L) gastroesophageal adenocarcinoma
  • Is not expected to require tumor resection during the treatment course
  • Tumor tissue must be confirmed as negative for human epidermal growth factor receptor 2 (HER2) expression as classified by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines
  • Core/excisional biopsy of a tumor lesion not previously irradiated has been provided
  • 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 therapy are eligible
  • Has adequate organ function
  • Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as determined by the local site investigator/radiology assessment and verified by blinded independent central review (BICR)
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 3 days prior to the first dose of study intervention
  • Has a life expectancy of at least 6 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 had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ)/esophageal adenocarcinoma
  • Has experienced weight loss >20% over 3 months before the first dose of study intervention
  • Has a 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 uncontrolled, significant cardiovascular disease or cerebrovascular disease within 6 months preceding study intervention
  • Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment
  • Has history of human immunodeficiency virus (HIV) infection with Kaposi's sarcoma and/or Multicentric Castleman's Disease
  • Has received prior treatment with a trophoblast antigen 2 (TROP2)-targeted or anti-human epidermal growth factor receptor 3 (HER3) targeted agents
  • Has received prior treatment with a topoisomerase I inhibitor-based antibody-drug conjugate (ADC) and/or a topoisomerase I inhibitor-based chemotherapy
  • Has received prior systemic anticancer therapy within 4 weeks before the first dose of study intervention
  • Has received prior therapy with an anti-Programmed Cell Death Protein 1 (PD-1), anti-Programmed Cell Death-Ligand 1 (PD-L1), anti-Programmed Cell Death-Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (TCR)
  • 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
  • Has received a strong inducer/inhibitor of CYP3A4 that cannot be discontinued
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy 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 Severe hypersensitivity (≥Grade 3) to pembrolizumab, sacituzumab tirumotecan, patritumab deruxtecan, or other biologic therapy, chemotherapy (ie, oxaliplatin, fluorouracil, capecitabine), leucovorin, levoleucovorin, or any of their excipients
  • Has active autoimmune disease that has required systemic treatment in the past 2 years
  • Has history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening
  • Has an active infection requiring systemic therapy
  • Has concurrent active hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive and/or detectable HBV DNA) and hepatitis C virus (defined as anti-hepatitis C virus [HCV] Ab positive and detectable HCV ribonucleic acid [RNA] infection or a known history of hepatitis B and/or C infection
  • Has history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study
  • Has gastrointestinal (GI) obstruction, poor oral intake, or difficulty in taking oral medication
  • Has poorly controlled diarrhea
  • Has had a major surgery or significant traumatic injury within 4 weeks before the first dose of study intervention
  • Has history of allogeneic tissue/solid organ transplant
  • Has not adequately recovered from major surgery or has ongoing surgical complications

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Pembrolizumab plus Chemotherapy

Participants will receive pembrolizumab 400 mg via intravenous (IV) injection on day 1 of every 6 week cycle (Q6W) for up to 18 cycles (up to ~2 years) AND investigator's choice of CAPOX chemotherapy (capecitabine 1000 mg/m^2 orally twice daily for 14 days every 3 weeks (Q3W) and oxaliplatin 130 mg/m^2 via IV infusion Q3W) OR mFOLFOX6 chemotherapy (oxaliplatin 85 mg/m^2 via IV infusion Q3W; 5-Fluorouracil (5-FU) 400 mg/^2 via bolus IV plus 2400 mg/m^2 continuous IV once every 2 weeks (Q2W); and leucovorin 400 mg/m^2 via IV infusion Q2W OR levoleucovorin 200 mg/m^2 Q2W).
Biologiczny: Pembrolizumab

Administered via intravenous (IV) infusion.

Inne nazwy:
  • MK-3475
  • Keytruda®
Lek: Capecitabine

Administered via oral tablet.

Inne nazwy:
  • XELODA
Lek: Leucovorin

Administered via IV infusion.

Inne nazwy:
  • kwas folinowy
  • WELLCOVORIN®
  • folinian wapnia
Lek: Levoleucovorin

Administered via IV infusion.

Inne nazwy:
  • FUSILEV®
  • lewofolinian wapnia
  • kwas lewofolinowy
Lek: 5-Fluorouracil (5-FU)

Administered via IV infusion

Inne nazwy:
  • ADRUCIL®
Lek: Oxaliplatin

Administered via IV infusion
Eksperymentalny: Pembrolizumab plus Sacituzumab Tirumotecan plus Chemotherapy

Participants will receive sacituzumab tirumotecan via IV infusion on Days 1, 15, and 29 Q6W until discontinuation, pembrolizumab 400 mg via IV injection on day 1 Q6W for up to 18 cycles (up to ~2 years) AND investigator's choice of capecitabine 1000 mg/m^2 orally twice daily for 14 days Q3W OR 5-FU 2400 mg/m^2 IV once Q2W AND leucovorin 400 mg/m^2 via IV infusion Q2W OR levoleucovorin 200 mg/m^2 Q2W.
Biologiczny: Pembrolizumab

Administered via intravenous (IV) infusion.

Inne nazwy:
  • MK-3475
  • Keytruda®
Lek: Capecitabine

Administered via oral tablet.

Inne nazwy:
  • XELODA
Lek: Leucovorin

Administered via IV infusion.

Inne nazwy:
  • kwas folinowy
  • WELLCOVORIN®
  • folinian wapnia
Lek: Levoleucovorin

Administered via IV infusion.

Inne nazwy:
  • FUSILEV®
  • lewofolinian wapnia
  • kwas lewofolinowy
Lek: 5-Fluorouracil (5-FU)

Administered via IV infusion

Inne nazwy:
  • ADRUCIL®
Biologiczny: Sacituzumab Tirumotecan (sac-TMT)

Administered via IV infusion.

Inne nazwy:
  • SKB264
  • MK-2870
Eksperymentalny: Pembrolizumab plus Patritumab Deruxtecan plus Chemotherapy

Participants will receive patritumab deruxtecan via IV infusion on Days 1 and 22 Q6W until discontinuation, pembrolizumab 400 mg via IV injection on day 1 Q6W for up to 18 cycles (up to ~2 years) AND investigator's choice of capecitabine 1000 mg/m^2 orally twice daily for 14 days Q3W OR 5-FU 2400 mg/m^2 IV once Q2W AND leucovorin 400 mg/m^2 via IV infusion Q2W OR levoleucovorin 200 mg/m^2 Q2W.
Biologiczny: Pembrolizumab

Administered via intravenous (IV) infusion.

Inne nazwy:
  • MK-3475
  • Keytruda®
Lek: Capecitabine

Administered via oral tablet.

Inne nazwy:
  • XELODA
Lek: Leucovorin

Administered via IV infusion.

Inne nazwy:
  • kwas folinowy
  • WELLCOVORIN®
  • folinian wapnia
Lek: Levoleucovorin

Administered via IV infusion.

Inne nazwy:
  • FUSILEV®
  • lewofolinian wapnia
  • kwas lewofolinowy
Lek: 5-Fluorouracil (5-FU)

Administered via IV infusion

Inne nazwy:
  • ADRUCIL®
Biologiczny: Patritumab Deruxtecan

Administered via IV infusion

Inne nazwy:
  • U3-1402
  • HER3-DXd
  • MK-1022

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Ramy czasowe: Up to approximately 28 days

DLTs are defined as any treatment-emergent adverse events (TEAEs) not attributable to disease or disease-related processes that occur during the DLT evaluation period and are a Grade 3 or higher according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0. The percentage of participants who experience at least one DLT will be reported.
Up to approximately 28 days
Safety Lead-in Phase: Number of Participants Who Experienced an Adverse Event (AE)
Ramy czasowe: Up to approximately 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. 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.
Up to approximately 28 days
Safety Lead-in Phase: Number of Participants Who Discontinued Study Intervention Due to an AE
Ramy czasowe: Up to approximately 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. 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.
Up to approximately 28 days
Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)
Ramy czasowe: Up to approximately 28 months

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR will be presented.
Up to approximately 28 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Ramy czasowe: Up to approximately 55 months

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.
Up to approximately 55 months
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Ramy czasowe: Up to approximately 55 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 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 approximately 55 months
Overall Survival (OS)
Ramy czasowe: Up to approximately 55 months

OS is defined as the time from randomization to the date of death from any cause.
Up to approximately 55 months
Number of Participants Who Experience an Adverse Event (AE)
Ramy czasowe: Up to approximately 55 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. 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.
Up to approximately 55 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Ramy czasowe: Up to approximately 55 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. 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.
Up to approximately 55 months
Incidence of Antidrug Antibodies (ADA) to investigational agents - (sacituzumab tirumotecan (sac-TMT, MK-2870) and patritumab deruxtecan (HER3-DXd))
Ramy czasowe: At designated timepoints up to approximately 55 months

Blood samples collected at designated timepoints will be used to determine the ADA response to investigational agents. The incidence of ADAs over time will be presented.
At designated timepoints up to approximately 55 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Merck Sharp & Dohme LLC

Śledczy

  • Dyrektor Studium: Medical Director, Merck Sharp & Dohme LLC

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 września 2024

Zakończenie podstawowe (Szacowany)

12 września 2029

Ukończenie studiów (Szacowany)

12 września 2029

Daty rejestracji na studia

Pierwszy przesłany

17 czerwca 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 czerwca 2024

Pierwszy wysłany (Rzeczywisty)

24 czerwca 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 3475-06C
  • MK-3475-06C (Inny identyfikator: MSD)
  • KEYMAKER-06C (Inny identyfikator: MSD)
  • U1111-1299-8084 (Identyfikator rejestru: UTN)
  • 2023-509307-33-00 (Identyfikator rejestru: EU CT)
  • 2023 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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