Sottostudio 06C: studio su sacituzumab tirumotecan (MK-2870) con pembrolizumab (MK-3475) e chemioterapia in partecipanti con adenocarcinoma gastroesofageo non resecabile/metastatico localmente avanzato di prima linea (MK-3475-06C/KEYMAKER-U06)
Uno studio di fase 1/2 in aperto, con piattaforma a ombrello, di MK-2870 con pembrolizumab (MK-3475) e chemioterapia in partecipanti con 1 litro di adenocarcinoma gastroesofageo localmente avanzato non resecabile/metastatico (adenocarcinoma gastrico, adenocarcinoma della giunzione gastroesofagea e adenocarcinoma esofageo): Sottostudio 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The master protocol is MK-3475-U06.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Toll Free Number
- Numero di telefono: 1-888-577-8839
- Email: Trialsites@msd.com
Luoghi di studio
-
-
-
São Paulo, Brasile, 03102-006
- Reclutamento
- IBCC - Instituto Brasileiro de Controle do Câncer ( Site 6304)
-
Contatto:
- Study Coordinator
- Numero di telefono: 551144500300
-
São Paulo, Brasile, 01246-000
- Reclutamento
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 6300)
-
Contatto:
- Study Coordinator
- Numero di telefono: 551138932000
-
-
Rio Grande do Norte
-
Natal, Rio Grande do Norte, Brasile, 59062-000
- Reclutamento
- Liga Norte Riograndense Contra o Câncer ( Site 6303)
-
Contatto:
- Study Coordinator
- Numero di telefono: +558440095595
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasile, 91350-200
- Reclutamento
- Hospital Nossa Senhora da Conceição ( Site 6301)
-
Contatto:
- Study Coordinator
- Numero di telefono: +5551993590437
-
-
-
-
-
Antofagasta, Chile, 1263521
- Reclutamento
- Bradford Hill Norte ( Site 6407)
-
Contatto:
- Study Coordinator
- Numero di telefono: 56442023631
-
-
Los Lagos Region
-
Port Montt, Los Lagos Region, Chile, 5500243
- Reclutamento
- Clínica Puerto Montt ( Site 6409)
-
Contatto:
- Study Coordinator
- Numero di telefono: 56961687093
-
-
Maule Region
-
Talca, Maule Region, Chile, 3481349
- Completato
- Centro de Investigación del Maule ( Site 6408)
-
-
Region M. de Santiago
-
Santiago, Region M. de Santiago, Chile, 7500921
- Reclutamento
- FALP-UIDO ( Site 6400)
-
Contatto:
- Study Coordinator
- Numero di telefono: 56224205098
-
Santiago, Region M. de Santiago, Chile, 7560908
- Reclutamento
- Centro de Oncología de Precisión-Oncology ( Site 6404)
-
Contatto:
- Study Coordinator
- Numero di telefono: 56225189885
-
Santiago, Region M. de Santiago, Chile, 7620002
- Reclutamento
- Clínica UC San Carlos de Apoquindo ( Site 6405)
-
Contatto:
- Study Coordinator
- Numero di telefono: 56934271024
-
Santiago, Region M. de Santiago, Chile, 8420383
- Reclutamento
- Bradfordhill-Clinical Area ( Site 6401)
-
Contatto:
- Study Coordinator
- Numero di telefono: 56229490970
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Cina, 100142
- Reclutamento
- Beijing Cancer hospital-Digestive Oncology ( Site 5500)
-
Contatto:
- Study Coordinator
- Numero di telefono: (010)88196317
-
-
Fujian
-
Fuzhou, Fujian, Cina, 350025
- Reclutamento
- The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 5501)
-
Contatto:
- Study Coordinator
- Numero di telefono: 0591-22859606
-
Xiamen, Fujian, Cina, 361003
- Reclutamento
- The First Affiliated hospital of Xiamen University ( Site 5503)
-
Contatto:
- Study Coordinator
- Numero di telefono: 0592-2139767
-
-
Henan
-
Zhengzhou, Henan, Cina, 450008
- Reclutamento
- Henan Cancer Hospital ( Site 5504)
-
Contatto:
- Study Coordinator
- Numero di telefono: 400-0371-818
-
-
Jiangxi
-
Nanchang, Jiangxi, Cina, 330000
- Reclutamento
- The First Affiliated Hospital of Nanchang University ( Site 5514)
-
Contatto:
- Study Coordinator
- Numero di telefono: 0791-86427234
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Cina, 200032
- Attivo, non reclutante
- Fudan University Shanghai Cancer Center ( Site 5513)
-
-
Xinjiang
-
Ürümqi, Xinjiang, Cina, 841100
- Attivo, non reclutante
- Xinjiang Medical University Cancer Hospital - Urumqi ( Site 5506)
-
-
Zhejiang
-
Hangzhou, Zhejiang, Cina, 310016
- Reclutamento
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5510)
-
Contatto:
- Study Coordinator
- Numero di telefono: 0571 8609 0073
-
-
-
-
-
Seoul, Corea del Sud, 05505
- Reclutamento
- Asan Medical Center-Department of Oncology ( Site 5901)
-
Contatto:
- Study Coordinator
- Numero di telefono: +82230103217
-
Seoul, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center-Division of Hematology/Oncology ( Site 5900)
-
Contatto:
- Study Coordinator
- Numero di telefono: 82234101795
-
-
-
-
Finistere
-
Brest, Finistere, Francia, 29200
- Reclutamento
- CHU-BREST Cavale Blanche ( Site 5104)
-
Contatto:
- Study Coordinator
- Numero di telefono: 33298223428
-
-
Nord
-
Lille, Nord, Francia, 59037
- Reclutamento
- CIC. ( Site 5100)
-
Contatto:
- Study Coordinator
- Numero di telefono: +33320445461
-
-
Île-de-France Region
-
Paris, Île-de-France Region, Francia, 75013
- Reclutamento
- Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 5102)
-
Contatto:
- Study Coordinator
- Numero di telefono: +331 42 16 10 41
-
-
-
-
Baden-Wurttemberg
-
Heidelberg, Baden-Wurttemberg, Germania, 69120
- Reclutamento
- NCT-Department of Medical Oncology ( Site 6809)
-
Contatto:
- Study Coordinator
- Numero di telefono: +49 62215637784
-
-
Free and Hanseatic City of Hamburg
-
Erdgeschoss, Free and Hanseatic City of Hamburg, Germania, 22297
- Reclutamento
- HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 6807)
-
Contatto:
- Study Coordinator
- Numero di telefono: + 4940360352246
-
-
North Rhine-Westphalia
-
Düsseldorf, North Rhine-Westphalia, Germania, 40225
- Completato
- Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 6802)
-
-
-
-
-
Milan, Italia, 20132
- Reclutamento
- Ospedale San Raffaele-Oncologia Medica ( Site 5202)
-
Contatto:
- Study Coordinator
- Numero di telefono: +390226437615
-
-
Emilia-Romagna
-
Meldola, Emilia-Romagna, Italia, 47014
- Reclutamento
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 5207)
-
Contatto:
- Study Coordinator
- Numero di telefono: 0543739100
-
-
Lombardy
-
Milan, Lombardy, Italia, 20133
- Reclutamento
- Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 5200)
-
Contatto:
- Study Coordinator
- Numero di telefono: 0223903807
-
-
Tuscany
-
Pisa, Tuscany, Italia, 56126
- Reclutamento
- Azienda Ospedaliero Universitaria Pisana ( Site 5206)
-
Contatto:
- Study Coordinator
- Numero di telefono: 050992454
-
-
-
-
-
Oslo, Norvegia, 0379
- Reclutamento
- Oslo universitetssykehus, Radiumhospitalet ( Site 6501)
-
Contatto:
- Study Coordinator
- Numero di telefono: 4723026600
-
-
-
-
Arizona
-
Tucson, Arizona, Stati Uniti, 85719
- Reclutamento
- University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 6927)
-
Contatto:
- Study Coordinator
- Numero di telefono: 520-621-2449
-
-
California
-
Los Angeles, California, Stati Uniti, 90404
- Reclutamento
- UCLA Hematology/Oncology - Santa Monica ( Site 6905)
-
Contatto:
- Study Coordinator
- Numero di telefono: 310-570-1453
-
-
Kentucky
-
Louisville, Kentucky, Stati Uniti, 40202
- Completato
- Norton Hospital-Norton Cancer Institute - Downtown ( Site 6900)
-
-
Michigan
-
Grand Rapids, Michigan, Stati Uniti, 49503
- Reclutamento
- The Cancer and Hematology Centers ( Site 6912)
-
Contatto:
- Study Coordinator
- Numero di telefono: 616-975-3065
-
-
New York
-
East Syracuse, New York, Stati Uniti, 13057
- Reclutamento
- Hematology-Oncology Associates of Central NY, P.C. ( Site 6925)
-
Contatto:
- Study Coordinator
- Numero di telefono: 315-472-7504
-
New York, New York, Stati Uniti, 10032
- Completato
- Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 6907)
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Stati Uniti, 15232
- Reclutamento
- UPMC Hillman Cancer Center-UPMC ( Site 6904)
-
Contatto:
- Study Coordinator
- Numero di telefono: 816-898-9413
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Reclutamento
- University of Texas MD Anderson Cancer Center ( Site 6920)
-
Contatto:
- Study Coordinator
- Numero di telefono: 833-589-0868
-
-
-
-
Canton of Geneva
-
Geneva, Canton of Geneva, Svizzera, 1211
- Reclutamento
- Hôpitaux Universitaires de Genève (HUG) ( Site 6701)
-
Contatto:
- Study Coordinator
- Numero di telefono: +41 22 372 29 01
-
-
Kanton Graubünden
-
Chur, Kanton Graubünden, Svizzera, 7000
- Reclutamento
- Kantonsspital Graubünden-Medizin ( Site 6700)
-
Contatto:
- Study Coordinator
- Numero di telefono: +41 81 256 61 11
-
-
-
-
Bangkok
-
Bangkoknoi, Bangkok, Tailandia, 10700
- Reclutamento
- Faculty of Medicine Siriraj Hospital ( Site 6102)
-
Contatto:
- Study Coordinator
- Numero di telefono: +6624194489
-
Pathumwan, Bangkok, Tailandia, 10330
- Reclutamento
- Chulalongkorn Hospital ( Site 6104)
-
Contatto:
- Study Coordinator
- Numero di telefono: 022564533
-
Ratchathewi, Bangkok, Tailandia, 10400
- Reclutamento
- Ramathibodi Hospital ( Site 6103)
-
Contatto:
- Study Coordinator
- Numero di telefono: 022011671
-
-
Changwat Songkhla
-
Hat Yai, Changwat Songkhla, Tailandia, 90110
- Reclutamento
- Songklanagarind hospital ( Site 6101)
-
Contatto:
- Study Coordinator
- Numero di telefono: +6674451469
-
-
-
-
-
Taichung, Taiwan, 404
- Reclutamento
- China Medical University Hospital ( Site 6007)
-
Contatto:
- Study Coordinator
- Numero di telefono: 886422052121x15057
-
Tainan, Taiwan, 704
- Reclutamento
- National Cheng Kung University Hospital ( Site 6001)
-
Contatto:
- Study Coordinator
- Numero di telefono: +88662353535x4559
-
Taipei, Taiwan, 10048
- Reclutamento
- National Taiwan University Hospital-Oncology ( Site 6000)
-
Contatto:
- Study Coordinator
- Numero di telefono: +88623123456x267852
-
Taipei, Taiwan, 112
- Reclutamento
- Taipei Veterans General Hospital ( Site 6005)
-
Contatto:
- Study Coordinator
- Numero di telefono: +88628717270x131
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
Altri nomi:
Administered via oral tablet.
Altri nomi:
Administered via IV infusion.
Altri nomi:
Administered via IV infusion.
Altri nomi:
Administered via IV infusion
Altri nomi:
Administered via IV infusion |
|
Sperimentale: 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.
Altri nomi:
Administered via oral tablet.
Altri nomi:
Administered via IV infusion.
Altri nomi:
Administered via IV infusion.
Altri nomi:
Administered via IV infusion
Altri nomi:
Administered via IV infusion.
Altri nomi:
|
|
Sperimentale: 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.
Altri nomi:
Administered via oral tablet.
Altri nomi:
Administered via IV infusion.
Altri nomi:
Administered via IV infusion.
Altri nomi:
Administered via IV infusion
Altri nomi:
Administered via IV infusion
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Safety Lead-in Phase: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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))
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Medical Director, Merck Sharp & Dohme LLC
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Neoplasie per sede
- Neoplasie
- Neoplasie gastrointestinali
- Neoplasie dell'apparato digerente
- Malattie dell'apparato digerente
- Malattie gastrointestinali
- Neoplasie della testa e del collo
- Malattie esofagee
- Neoplasie esofagee
- Malattia di Parkinson 4, corpo di Lewy autosomico dominante
- Prodotti chimici organici
- Composti eterociclici, 1-anello
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Acidi nucleici, nucleotidi e nucleosidi
- Enzimi e coenzimi
- Complessi di coordinamento
- Deossictidina
- Citidina
- Nucleosidi di pirimidina
- Pirimidine
- Nucleosidi
- Formyltetraidrofolates
- Tetraidrofolati
- Acido folico
- Pterins
- Pteridine
- Uracile
- Pirimidinoni
- Coenzimi
- Deossiribonucleosidi
- Capecitabina
- Oxaliplatino
- Fluorouracile
- Leucovorina
- Levoleucovorin
- pembrolizumab
- Patritumab Deruxtecan
Altri numeri di identificazione dello studio
- 3475-06C
- MK-3475-06C (Altro identificatore: MSD)
- KEYMAKER-06C (Altro identificatore: MSD)
- U1111-1299-8084 (Identificatore di registro: UTN)
- 2023-509307-33-00 (Identificatore di registro: EU CT)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .