Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06)
A legfontosabb adatok
- Ki végzi
- Merck Sharp & Dohme LLC
- Hol
- Kaohsiung City, Kaoshiung, Taichung, Tainan, Taipei és Taoyuan (Tajvan)Mind a 8 helyszín megnézéseMég 15 másik országban, 46 helyszínen
- Azonosító
- NCT06780111
- EU 2024-514273-22-00
- JRCT2041240166
- U1111-1307-6484
- Állapot
- Toboroz
- Fázis
- 1/2. fázis
- Résztvevők
- 298 fő, tervezett
- Kezdés
- 2025. júl. 30.
- Várható befejezés
- 2032. jan. 4.
- A vizsgálat típusa
- Beavatkozással járó, 5 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Pembrolizumab
- I-DXd
- Leucovorin
- Levoleucovorin
- 5-Fluorouracil (5-FU)
- Oxaliplatin
- Sacituzumab tirumotecan
- Rescue Medication
- A regiszteradat frissítve
- 2026. november 13.
Ki vehet részt
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan felnőtteket keres, akiknek a nyelőcső laphámrákja műtéttel nem eltávolítható vagy áttétes, és erre még nem kaptak kezelést.
- Életkor
- 18 éves vagy idősebb
- Nem
- Nemtől függetlenül bárki részt vehet.
- A betegség stádiuma
- Nyelőcső laphámrákja, amely helyileg előrehaladott és műtéttel nem eltávolítható, vagy áttétes, az első vonalbeli kezelés időszakában. A betegségnek a képalkotó vizsgálatokon mérhetőnek kell lennie (RECIST 1.1).
- Korábbi kezelés
- Nem kaphatott korábban rákellenes kezelést az előrehaladott vagy áttétes nyelőcsőrákra. Nem kaphatott korábban anti-PD-1, anti-PD-L1 vagy anti-PD-L2 kezelést. A korábbi kezelések mellékhatásainak 1-es fokozatra vagy a kiindulási állapotra kell javulniuk.
A részvétel fő kizáró okai
- Korábbi szisztémás rákellenes kezelés az előrehaladott vagy áttétes nyelőcsőrákra
- Korábbi anti-PD-1, anti-PD-L1 vagy anti-PD-L2 kezelés
- Aktív központi idegrendszeri áttét vagy carcinomás agyhártyagyulladás
- Korábbi intersticiális tüdőbetegség vagy tüdőgyulladás (kivéve a szteroidot nem igénylő sugárkezelés okozta tüdőgyulladást)
- Aktív autoimmun betegség, amely az elmúlt 2 évben szisztémás kezelést igényelt
A regiszter feltételei, szó szerint
Mind a 27 feltétel megnézéseKevesebb
Ki vehet részt
- The main inclusion criteria include but are not limited to the following:
- Has histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic squamous cell carcinoma of the esophagus in first-line (1L) setting
- Has measurable disease per RECIST 1.1 as assessed by the local site. investigator or designee/radiology assessment and verified by BICR. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions
- Has had AEs due to previous anticancer therapies that have recovered to ≤Grade 1 or baseline. Endocrine-related AEs that are adequately treated with hormone replacement are elegible
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
- Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Has adequate organ function
Ki nem vehet részt
- Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor
- Has received prior systemic anticancer therapy including investigational agents 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 diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
- Has had systemic anticancer therapy for locally advanced unresectable or metastatic esophageal cancer
- Has tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula
- Has clinically significant corneal disease, history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has clinically significant cardiovascular disease within 6 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Has had a history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use (except for a history of radiation pneumonitis that did not require steroids), has a current diagnosis of ILD, or has clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out
- Has active infection requiring systemic therapy
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses, including, but not limited to, any underlying pulmonary disorder
- Has inadequate cardiac function assessed as by a corrected QT interval by Fredericia (QTcF) value ≥470 msec
- The main exclusion criteria include but are not limited to the following:
- Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
- Has peripheral neuropathy ≥ Grade 2
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Helyszínek itt: Tajvan
Még 15 másik országban, 46 helyszínen
- Kaohsiung Chang Gung Memorial Hospital (Site 1003)Kaohsiung City, TajvanContact: Study CoordinatorRésztvevőt keres
- Kaohsiung Medical University Chung-Ho Memorial Hospital (Site 1009)Kaoshiung, TajvanContact: Study CoordinatorRésztvevőt keres
- China Medical University Hospital (Site 1007)Taichung, TajvanContact: Study CoordinatorRésztvevőt keres
- National Cheng Kung University Hospital (Site 1001)Tainan, TajvanContact: Study CoordinatorRésztvevőt keres
- National Taiwan University Cancer Center (Site 1010)Taipei, TajvanContact: Study CoordinatorRésztvevőt keres
- National Taiwan University Hospital (Site 1000)Taipei, TajvanContact: Study CoordinatorRésztvevőt keres
- Taipei Veterans General Hospital (Site 1005)Taipei, TajvanContact: Study CoordinatorRésztvevőt keres
- Chang Gung Memorial Hospital - Linkou Branch (Site 1006)Taoyuan, TajvanContact: Study CoordinatorRésztvevőt keres
A vizsgálatról
Mit akar kideríteni a vizsgálat
Researchers are looking for new ways to treat esophageal squamous cell carcinoma (ESCC). ESCC is a type of cancer that starts in certain cells that line the esophagus. The esophagus is the tube that connects the throat to the stomach. This study will look at ESCC that is either locally advanced unresectable, which means it has spread into tissue near where it started and cannot be completely removed by surgery, or metastatic, which means it has spread to other body parts.
A teljes eredeti leírásKevesebb
Available treatments for these types of ESCC include pembrolizumab and chemotherapy. Pembrolizumab is an immunotherapy, which is a treatment that helps the immune system fight cancer. Chemotherapy is medicine that destroys cancer cells or stops them from growing.
Researchers want to learn about giving pembrolizumab and investigational agents, with or without chemotherapy to treat ESCC. Ifinatamab deruxtecan (I-DXd), is an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.
The main goal of this study is to learn about the safety of investigational agents and pembrolizumab with or without chemotherapy and if people tolerate them. Researchers also want to learn how cancer responds (gets smaller or goes away) to the study treatments.
A vizsgálat 5 csoportja
- Pembrolizumab + ChemotherapyMár használt kezelés, összehasonlításként
Participants will receive 400 mg of pembrolizumab via intravenous (IV) infusion every six weeks (Q6W) on Day 1 of each 42-day cycle up to 18 cycles (up to approximately 2 years), and mFOLFOX6 chemotherapy: oxaliplatin 85 mg/m\^2 via IV infusion every 2 weeks (Q2W), until progressive disease (PD) or toxicity; leucovorin 400 mg/m\^2 OR levoleucovorin 200 mg/m\^2 via IV infusion Q2W, until PD or toxicity; 5-fluorouracil (5-FU) 400 mg/m\^2 bolus IV infusion followed by 2400 mg/m\^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity.
Kezelés: Pembrolizumab, Leucovorin, Levoleucovorin, 5-Fluorouracil (5-FU) és Oxaliplatin
- Pembrolizumab + I-DXdA vizsgált kezelés
Participants will receive 200 mg of pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle for up to 35 cycles (up to approximately 2 years). Participants will also receive up to 12 mg/kg I-XDd Q3W via IV infusion, until PD or toxicity.
Kezelés: Pembrolizumab, I-DXd és Rescue Medication
- Pembrolizumab + I-DXd + 5-FU IV + Leucovorin or LevoleucovorinA vizsgált kezelés
Participants will receive 200 mg pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle up to 35 cycles (up to approximately 2 years). Participants will also receive I-DXd up to 12 mg/kg via IV infusion Q3W, until PD or toxicity; 5-FU 400 mg/m\^2 bolus IV infusion followed by 2400 mg/m\^2 continuous 46-48 hour IV infusion Q2W, OR 2400 mg/m\^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m\^2 OR levoleucovorin 200 mg/m\^2 via IV infusion Q2W, until PD or toxicity.
Kezelés: Pembrolizumab, I-DXd, Leucovorin, Levoleucovorin, 5-Fluorouracil (5-FU) és Rescue Medication
- Pembrolizumab + I-DXd + 5-FU IV + Leucovorin or Levoleucovorin + OxaliplatinA vizsgált kezelés
Participants will receive 200 mg of pembrolizumab via IV infusion Q3W on Day 1 of each 21-day cycle up to 35 cycles (up to approximately 2 years). Participants will also receive up to 12 mg/kg I-DXd via IV infusion q3w, until PD or toxicity; 5-FU 2400 mg/m\^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; 60mg/m\^2 oxaliplatin via IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m\^2 OR levoleucovorin 200 mg/m\^2 via IV infusion Q2W, until PD or toxicity.
Kezelés: Pembrolizumab, I-DXd, Leucovorin, Levoleucovorin, 5-Fluorouracil (5-FU), Oxaliplatin és Rescue Medication
- Pembrolizumab + Sacituzumab tirumotecan + 5-FU IV + Leucovorin or LevoleucovorinA vizsgált kezelés
Participants will receive 400 mg pembrolizumab via IV infusion Q6W on Day 1 of each 42-day cycle up to 18 cycles (up to approximately 2 years). Participants will also receive sacituzumab tirumotecan 4 mg/kg via IV infusion Days 1, 15, and 29 every 42-day cycle, until PD or toxicity; 5-FU 400 mg/m\^2 bolus IV infusion followed by 2400 mg/m\^2 continuous 46-48 hour IV infusion Q2W, OR 2400 mg/m\^2 continuous 46-48 hour IV infusion Q2W, until PD or toxicity; and leucovorin 400 mg/m\^2 OR levoleucovorin 200 mg/m\^2 via IV infusion Q2W, until PD or toxicity.
Kezelés: Pembrolizumab, Leucovorin, Levoleucovorin, 5-Fluorouracil (5-FU), Sacituzumab tirumotecan és Rescue Medication
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakAdatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on és az EU hivatalos vizsgálati nyilvántartásában (CTIS).
- Hivatalos cím
- A Phase 1/2 Open-Label, Umbrella Platform Design Study of Investigational Agents in Combination With Pembrolizumab (MK-3475) With or Without Chemotherapy in Participants With 1L Locally Advanced Unresectable/Metastatic Esophageal Cancer: KEYMAKER-U06 Substudy 06E
- MI-összefoglaló
- A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
- A regiszteradat frissítve
- 2026. november 13.