Substudy 06D: Combination Therapies in Second Line (2L) Gastroesophageal Adenocarcinoma (MK-3475-06D/Keymaker-U06)
Condition(s) studied
Investigational drug(s) / intervention(s)
Ramucirumab: 8 mg/kg IV Infusion
Paclitaxel: 80 mg/M\^2 IV infusion
Sacituzumab Tirumotecan: 3 mg/kg or 4 mg/kg IV Infusion
Rescue Medications: Participants receive rescue medications according to each approved drug's product label. Recommended rescue medications for the Sacituzumab Tirumotecan + Paclitaxel arm include antihistamines (histamine-1 and histamine-2 receptor antagonists), acetaminophen or equivalent, dexamethasone or equivalent infusion, and steroid mouth wash (dexamethasone or equivalent) and rescue medications for the HER3-DXd + ramucirumab arm include 5-HT3-receptor antagonist, NK-1 receptor antagonist, and corticosteroids.
HER3-DXd: IV Infusion
Study summary
This is a phase 1/2 multicenter, open-label umbrella platform study that will evaluate the safety and efficacy of sacituzumab tirumotecan (MK-2870) plus paclitaxel versus ramucirumab plus paclitaxel, and HER3-DXD plus ramucirumab versus ramucirumab plus paclitaxel for the treatment of participants with advanced or metastatic gastric adenocarcinoma, gastroesophageal junction (GEJ) adenocarcinoma, or esophageal adenocarcinoma who have failed 1 prior line of therapy. This is an estimation study, and no formal hypothesis testing will be performed.
Eligibility
Primary outcome measure(s)
- Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) During the Safety Lead-In Phase — Up to ~28 days
DLTs are defined as any drug-related adverse event (AE) according to the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle. The percentage of participants who experience at least one DLT will be presented. - Percentage of Particiapants who Experience an Adverse Event (AE) During the Safety Lead-In Phase — Up to ~60 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. The percentage of participants who discontinued study intervention due to an AE will be presented. - Percentage of Participants who Discontinue Study Intervention Due to an AE During the Safety Lead-In Phase — Up to ~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. The percentage of participants who discontinued study intervention due to an AE will be presented. - Objective Response Rate (ORR) — Up to ~28 months
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Arizona Cancer Center-University of Arizona Cancer Center ( Site 8927) | Tucson | Arizona | Recruiting |
| UCLA Hematology/Oncology - Santa Monica ( Site 8905) | Los Angeles | California | Recruiting |
| Norton Cancer Institute - Downtown ( Site 8900) | Louisville | Kentucky | Completed |
| The Cancer and Hematology Centers ( Site 8912) | Grand Rapids | Michigan | Recruiting |
| Hematology-Oncology Associates of Central NY, P.C. ( Site 8925) | East Syracuse | New York | Recruiting |
| Columbia University Irving Medical Center-CUIMC Herbert Irving Comprehensive Cancer Center Clinical ( Site 8907) | New York | New York | Completed |
| UPMC Hillman Cancer Center-UPMC ( Site 8904) | Pittsburgh | Pennsylvania | Recruiting |
| University of Texas MD Anderson Cancer Center ( Site 8920) | Houston | Texas | Recruiting |
| Liga Norte Riograndense Contra o Câncer ( Site 8303) | Natal | Rio Grande do Norte | Recruiting |
| Hospital Nossa Senhora da Conceição ( Site 8301) | Porto Alegre | Rio Grande do Sul | Recruiting |
| IBCC - Instituto Brasileiro de Controle do Câncer ( Site 8304) | São Paulo | São Paulo | Recruiting |
| ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 8300) | São Paulo | Brazil | Recruiting |
| Clínica Puerto Montt ( Site 8409) | Port Montt | Los Lagos Region | Recruiting |
| Centro de Investigación del Maule ( Site 8408) | Talca | Maule Region | Recruiting |
| FALP-UIDO ( Site 8400) | Santiago | Region M. de Santiago | Recruiting |
| Centro de Oncología de Precisión-Oncology ( Site 8404) | Santiago | Region M. de Santiago | Recruiting |
| Clínica UC San Carlos de Apoquindo ( Site 8405) | Santiago | Region M. de Santiago | Recruiting |
| Bradfordhill-Clinical Area ( Site 8401) | Santiago | Region M. de Santiago | Recruiting |
| Bradford Hill Norte ( Site 8407) | Antofagasta | Chile | Recruiting |
| Beijing Cancer hospital-Digestive Oncology ( Site 7500) | Beijing | Beijing Municipality | Recruiting |
| The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 7501) | Fuzhou | Fujian | Recruiting |
| The First Affiliated hospital of Xiamen University ( Site 7503) | Xiamen | Fujian | Recruiting |
| Henan Cancer Hospital ( Site 7504) | Zhengzhou | Henan | Recruiting |
| The First Affiliated Hospital of Nanchang University ( Site 7514) | Nanchang | Jiangxi | Recruiting |
| Fudan University Shanghai Cancer Center ( Site 7513) | Shanghai | Shanghai Municipality | Recruiting |
| Xinjiang Medical University Cancer Hospital - Urumqi ( Site 7506) | Ürümqi | Xinjiang | Recruiting |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 7510) | Hangzhou | Zhejiang | Recruiting |
| Centre Hospitalier Régional Universitaire de Brest - Hôpital-Institut de cancérologie et hématologi ( Site 7104) | Brest | Finistere | Recruiting |
| CIC. ( Site 7100) | Lille | Nord | Recruiting |
| Pitie Salpetriere University Hospital-Hepato-Gastro-Enterology ( Site 7102) | Paris | Île-de-France Region | Recruiting |
| NCT-Department of Medical Oncology ( Site 8809) | Heidelberg | Baden-Wurttemberg | Recruiting |
| HOPE Hamburg/Norddeutsches Studienzentrum fuer Innovative Onkologie ( Site 8807) | Erdgeschoss | Free and Hanseatic City of Hamburg | Recruiting |
| Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 8802) | Düsseldorf | North Rhine-Westphalia | Recruiting |
| IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"-Oncologia Medica ( Site 7207) | Meldola | Emilia-Romagna | Recruiting |
| Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 7200) | Milan | Lombardy | Recruiting |
| Azienda Ospedaliero Universitaria Pisana ( Site 7206) | Pisa | Tuscany | Recruiting |
| Ospedale San Raffaele-Oncologia Medica ( Site 7202) | Milan | Italy | Recruiting |
| Oslo universitetssykehus, Radiumhospitalet ( Site 8501) | Oslo | Norway | Recruiting |
| Asan Medical Center-Department of Oncology ( Site 7901) | Seoul | South Korea | Recruiting |
| Samsung Medical Center-Division of Hematology/Oncology ( Site 7900) | Seoul | South Korea | Recruiting |
+ 6 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06445972 on ClinicalTrials.gov ↗ ← All trials in the USA