Delstudie 06C: En studie av Sacituzumab Tirumotecan (MK-2870) med Pembrolizumab (MK-3475) og kjemoterapi hos deltakere med førstelinjes lokalt avansert ikke-opererbart/metastatisk gastroøsofagealt adenokarsinom (MK-3475-06C/06C)
En fase 1/2 Open-Label, paraplyplattformdesignstudie av MK-2870 med Pembrolizumab (MK-3475) og kjemoterapi hos deltakere med 1L lokalt avansert ikke-opererbart/metastatisk gastroøsofagealt adenokarsinom (gastrisk adenokarsinom, gastroøsofagealt adenokarcinom og esophagealt øsofagealcinom): Delstudie 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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The master protocol is MK-3475-U06.
Studietype
Registrering (Antatt)
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Toll Free Number
- Telefonnummer: 1-888-577-8839
- E-post: Trialsites@msd.com
Studiesteder
-
-
-
São Paulo, Brasil, 03102-006
- Rekruttering
- IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 551144500300
-
São Paulo, Brasil, 01246-000
- Rekruttering
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 551138932000
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brasil, 59062-000
- Rekruttering
- Liga Norte Riograndense Contra o Câncer ( Site 6303)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +558440095595
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil, 91350-200
- Rekruttering
- Hospital Nossa Senhora da Conceição ( Site 6301)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +5551993590437
-
-
-
-
-
Antofagasta, Chile, 1263521
- Rekruttering
- Bradford Hill Norte ( Site 6407)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 56442023631
-
-
Los Lagos Region
-
Port Montt, Los Lagos Region, Chile, 5500243
- Rekruttering
- Clínica Puerto Montt ( Site 6409)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 56961687093
-
-
Maule Region
-
Talca, Maule Region, Chile, 3481349
- Fullført
- Centro de Investigación del Maule ( Site 6408)
-
-
Region M. de Santiago
-
Santiago, Region M. de Santiago, Chile, 7500921
- Rekruttering
- FALP-UIDO ( Site 6400)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 56224205098
-
Santiago, Region M. de Santiago, Chile, 7560908
- Rekruttering
- Centro de Oncología de Precisión-Oncology ( Site 6404)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 56225189885
-
Santiago, Region M. de Santiago, Chile, 7620002
- Rekruttering
- Clínica UC San Carlos de Apoquindo ( Site 6405)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 56934271024
-
Santiago, Region M. de Santiago, Chile, 8420383
- Rekruttering
- Bradfordhill-Clinical Area ( Site 6401)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 56229490970
-
-
-
-
Arizona
-
Tucson, Arizona, Forente stater, 85719
- Rekruttering
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 520-621-2449
-
-
California
-
Los Angeles, California, Forente stater, 90404
- Rekruttering
- UCLA Hematology/Oncology - Santa Monica ( Site 6905)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 310-570-1453
-
-
Kentucky
-
Louisville, Kentucky, Forente stater, 40202
- Fullført
- Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)
-
-
Michigan
-
Grand Rapids, Michigan, Forente stater, 49503
- Rekruttering
- The Cancer and Hematology Centers ( Site 6912)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 616-975-3065
-
-
New York
-
East Syracuse, New York, Forente stater, 13057
- Rekruttering
- Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 315-472-7504
-
New York, New York, Forente stater, 10032
- Fullført
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forente stater, 15232
- Rekruttering
- UPMC Hillman Cancer Center-UPMC ( Site 6904)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 816-898-9413
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- Rekruttering
- University of Texas MD Anderson Cancer Center ( Site 6920)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 833-589-0868
-
-
-
-
Finistere
-
Brest, Finistere, Frankrike, 29200
- Rekruttering
- CHU-BREST Cavale Blanche ( Site 5104)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 33298223428
-
-
Nord
-
Lille, Nord, Frankrike, 59037
- Rekruttering
- CIC. ( Site 5100)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +33320445461
-
-
Île-de-France Region
-
Paris, Île-de-France Region, Frankrike, 75013
- Rekruttering
- Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +331 42 16 10 41
-
-
-
-
-
Milan, Italia, 20132
- Rekruttering
- Ospedale San Raffaele-Oncologia Medica ( Site 5202)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +390226437615
-
-
Emilia-Romagna
-
Meldola, Emilia-Romagna, Italia, 47014
- Rekruttering
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 5207)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0543739100
-
-
Lombardy
-
Milan, Lombardy, Italia, 20133
- Rekruttering
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0223903807
-
-
Tuscany
-
Pisa, Tuscany, Italia, 56126
- Rekruttering
- Azienda Ospedaliero Universitaria Pisana ( Site 5206)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 050992454
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer hospital-Digestive Oncology ( Site 5500)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: (010)88196317
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350025
- Rekruttering
- The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0591-22859606
-
Xiamen, Fujian, Kina, 361003
- Rekruttering
- The First Affiliated hospital of Xiamen University ( Site 5503)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0592-2139767
-
-
Henan
-
Zhengzhou, Henan, Kina, 450008
- Rekruttering
- Henan Cancer Hospital ( Site 5504)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 400-0371-818
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330000
- Rekruttering
- The First Affiliated Hospital of Nanchang University ( Site 5514)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0791-86427234
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200032
- Aktiv, ikke rekrutterende
- Fudan University Shanghai Cancer Center ( Site 5513)
-
-
Xinjiang
-
Ürümqi, Xinjiang, Kina, 841100
- Aktiv, ikke rekrutterende
- Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310016
- Rekruttering
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 0571 8609 0073
-
-
-
-
-
Oslo, Norge, 0379
- Rekruttering
- Oslo universitetssykehus, Radiumhospitalet ( Site 6501)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 4723026600
-
-
-
-
Canton of Geneva
-
Geneva, Canton of Geneva, Sveits, 1211
- Rekruttering
- Hôpitaux Universitaires de Genève (HUG) ( Site 6701)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41 22 372 29 01
-
-
Kanton Graubünden
-
Chur, Kanton Graubünden, Sveits, 7000
- Rekruttering
- Kantonsspital Graubünden-Medizin ( Site 6700)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +41 81 256 61 11
-
-
-
-
-
Seoul, Sør -Korea, 05505
- Rekruttering
- Asan Medical Center-Department of Oncology ( Site 5901)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +82230103217
-
Seoul, Sør -Korea, 06351
- Rekruttering
- Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 82234101795
-
-
-
-
-
Taichung, Taiwan, 404
- Rekruttering
- China Medical University Hospital ( Site 6007)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 886422052121x15057
-
Tainan, Taiwan, 704
- Rekruttering
- National Cheng Kung University Hospital ( Site 6001)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88662353535x4559
-
Taipei, Taiwan, 10048
- Rekruttering
- National Taiwan University Hospital-Oncology ( Site 6000)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88623123456x267852
-
Taipei, Taiwan, 112
- Rekruttering
- Taipei Veterans General Hospital ( Site 6005)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +88628717270x131
-
-
-
-
Bangkok
-
Bangkoknoi, Bangkok, Thailand, 10700
- Rekruttering
- Faculty of Medicine Siriraj Hospital ( Site 6102)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6624194489
-
Pathumwan, Bangkok, Thailand, 10330
- Rekruttering
- Chulalongkorn Hospital ( Site 6104)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 022564533
-
Ratchathewi, Bangkok, Thailand, 10400
- Rekruttering
- Ramathibodi Hospital ( Site 6103)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: 022011671
-
-
Changwat Songkhla
-
Hat Yai, Changwat Songkhla, Thailand, 90110
- Rekruttering
- Songklanagarind hospital ( Site 6101)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +6674451469
-
-
-
-
Baden-Wurttemberg
-
Heidelberg, Baden-Wurttemberg, Tyskland, 69120
- Rekruttering
- NCT-Department of Medical Oncology ( Site 6809)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: +49 62215637784
-
-
Free and Hanseatic City of Hamburg
-
Erdgeschoss, Free and Hanseatic City of Hamburg, Tyskland, 22297
- Rekruttering
- HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 6807)
-
Ta kontakt med:
- Study Coordinator
- Telefonnummer: + 4940360352246
-
-
North Rhine-Westphalia
-
Düsseldorf, North Rhine-Westphalia, Tyskland, 40225
- Fullført
- Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv 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). |
Administered via intravenous (IV) infusion.
Andre navn:
Administered via oral tablet.
Andre navn:
Administered via IV infusion.
Andre navn:
Administered via IV infusion.
Andre navn:
Administered via IV infusion
Andre navn:
Administered via IV infusion |
|
Eksperimentell: 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. |
Administered via intravenous (IV) infusion.
Andre navn:
Administered via oral tablet.
Andre navn:
Administered via IV infusion.
Andre navn:
Administered via IV infusion.
Andre navn:
Administered via IV infusion
Andre navn:
Administered via IV infusion.
Andre navn:
|
|
Eksperimentell: 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. |
Administered via intravenous (IV) infusion.
Andre navn:
Administered via oral tablet.
Andre navn:
Administered via IV infusion.
Andre navn:
Administered via IV infusion.
Andre navn:
Administered via IV infusion
Andre navn:
Administered via IV infusion
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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))
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Medical Director, Merck Sharp & Dohme LLC
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i hode og nakke
- Esophageal sykdommer
- Neoplasmer i spiserøret
- Parkinsons sykdom 4, autosomal dominerende lewy kropp
- Organiske kjemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ringen
- Nukleinsyrer, nukleotider og nukleosider
- Enzymer og koenzymer
- Koordinasjonskomplekser
- Deoxycytidine
- Cytidin
- Pyrimidin -nukleosider
- Pyrimidiner
- Nukleosider
- Formyltetrahydrofolater
- Tetrahydrofolater
- Folsyre
- Pteriner
- Pteridiner
- Uracil
- Pyrimidinoner
- Koenzymer
- Deoxyribonucleosides
- Capecitabin
- Oksaliplatin
- Fluorouracil
- Leucovorin
- Levoleucovorin
- pembrolizumab
- Patritumab Deruxtecan
Andre studie-ID-numre
- 3475-06C
- MK-3475-06C (Annen identifikator: MSD)
- KEYMAKER-06C (Annen identifikator: MSD)
- U1111-1299-8084 (Registeridentifikator: UTN)
- 2023-509307-33-00 (Registeridentifikator: EU CT)
- 2023 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .