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Набира участници Фаза 1/2 NCT06780137

A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002)

Фаза 1/2 – комбинирано ранно изпитване
Заболявания: Small Cell Lung Cancer

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
Researchers are looking for new ways to treat people with extensive-stage small cell lung cancer (SCLC) that has relapsed or is refractory. Gocatamig is a new type of immunotherapy that uses a person's immune system to find and destroy cancer cells. Ifinatamab deruxtecan (also known as I-DXd) is a drug which binds to a specific target on cancer cells and delivers treatment to destroy those cells. Durvalumab is a different type of immunotherapy that also destroys cancer cells. Researchers want to know if giving gocatamig, I-DXd, and gocatamig with I-DXd or durvalumab can treat SCLC that did not respond or stopped responding to a prior treatment. The goals of this study are to learn: * If gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab are safe and well tolerated * If people who receive gocatamig alone, I-DXd alone, and gocatamig with I-DXd or durvalumab have their SCLC get smaller or go away
Описание
This study will consist of two parts. Part 1 will assess the safety, tolerability, and efficacy of gocatamig and I-DXd at doses determined in study MK-6070-001 (NCT: NCT04471727). Part 2 will assess the safety and tolerability of gocatamig in participants in Japan and China. Part 3 will assess the safety, tolerability, and efficacy of gocatamig with durvalumab.
Кой може да участва
Inclusion Criteria: * Has histologically or cytologically confirmed SCLC that is extensive stage (defined as Stage IV (T any, N any, M1a/b/c) following at least 1 prior line of systemic therapy that included platinum-based chemotherapy * Must be able to provide archival tumor tissue sample or fresh biopsy tissue sample * Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART) Exclusion Criteria: * Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure * History of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use or has current or suspected pneumonitis/ILD that cannot be ruled out by imaging at screening * Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * Active or history of immune deficiency with the exception of HIV-infected participants with well controlled HIV on ART * History within 6 months before the first dose of study intervention of coronary/peripheral artery bypass graft and/or any coronary/peripheral angioplasty or clinically significant cardiovascular disease such as myocardial infarction, symptomatic congestive heart failure (CHF) (New York Heart Association \> class II), and/or uncontrolled cardiac arrhythmia * History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention * Active clinically significant infection requiring systemic therapy * History of allogeneic tissue/solid organ transplant * History of leptomeningeal disease * Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of chronic immunosuppressive therapy within 7 days prior to the first dose of study intervention * Known additional malignancy that is progressing or has required active treatment within the past 3 years * Untreated or symptomatic brain metastases * Active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulin M \[IgM\] positive in the setting of associated signs/symptoms), hepatitis B (hepatitis B virus surface antigen \[HbsAg\] positive and/or detectable hepatitis B virus \[HBV\] deoxyribonucleic acid \[DNA\]), or hepatitis C (hepatitis C virus \[HCV\] antibody positive and detectable HCV ribonucleic acid). Participants with HBV with undetectable viral load after treatment are eligible. Participants with HCV with undetectable virus after treatment are eligible. * Part 1 only: Radiation therapy to the lung \>30 Gy within 6 months before the start of study intervention * Part 1 only: Abdominal radiation within 4 weeks before start of study intervention * Part 1 only: Anticancer hormonal treatment (except luteinizing hormone-releasing hormone \[LHRH\]) within 2 weeks before start of study intervention * Part 1 only: Systemic anticancer therapy (except antibody-based anticancer therapy) or investigational agents within 3 weeks or 5 half-lives, whichever is longer * Part 1 only: Antibody-based cancer therapy within 3 weeks before start of study intervention * Part 1 only: Chloroquine/hydroxychloroquine within 2 weeks before start of study intervention * Part 1 only: Clinically significant corneal disease * Part 1 only: Has other uncontrolled or significant protocol-specified cardiovascular disease
Интервенции
Gocatamig
BIOLOGICAL
Ifinatamab Deruxtecan (I-DXd)
BIOLOGICAL
Durvalumab
BIOLOGICAL
Места на провеждане 48
Argentina (2)
Hospital Universitario Austral ( Site 2204)
Pilar , Buenos Aires
Study Coordinator
Sanatorio Parque ( Site 2203)
Rosario , Santa Fe Province
Study Coordinator
Австралия (2)
Monash Health ( Site 5301)
Clayton , Victoria
Study Coordinator
Princess Alexandra Hospital ( Site 5300)
Woolloongabba , Queensland
Study Coordinator
Chile (3)
FALP ( Site 2100)
Santiago , Region M. de Santiago
Study Coordinator
Pontificia Universidad Catolica de Chile ( Site 2102)
Santiago , Region M. de Santiago
Study Coordinator
Bradfordhill ( Site 2101)
Santiago , Region M. de Santiago
Study Coordinator
Китай (7)
Beijing Cancer Hospital ( Site 5401)
Beijing , Beijing Municipality
Study Coordinator
West China Hospital of Sichuan University ( Site 5416)
Chengdu , Sichuan
Study Coordinator
Fujian Cancer Hospital ( Site 5413)
Fuzhou , Fujian
Study Coordinator
The First Affiliated Hospital, Zhejiang University ( Site 5404)
Hangzhou , Zhejiang
Study Coordinator
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Oncology ( Site 5403)
Nanjing , Jiangsu
Study Coordinator
Shanghai Chest Hospital ( Site 5400)
Shanghai , Shanghai Municipality
Study Coordinator
Shanghai Pulmonary Hospital ( Site 5405)
Shanghai , Shanghai Municipality
Study Coordinator
Израел (4)
Rambam Health Care Campus ( Site 3202)
Haifa
ACTIVE_NOT_RECRUITING
Shaare Zedek Medical Center ( Site 3200)
Jerusalem
Study Coordinator
Rabin Medical Center ( Site 3203)
Petah Tikva
Study Coordinator
Sheba Medical Center ( Site 3201)
Ramat Gan
Study Coordinator
Япония (4)
Kansai Medical University Hospital ( Site 5004)
Hirakata , Osaka
Study Coordinator
National Cancer Center Hospital East ( Site 5001)
Kashiwa , Chiba
Study Coordinator
Cancer Institute Hospital of JFCR ( Site 5002)
Koto , Tokyo
Study Coordinator
Aichi Cancer Center ( Site 5000)
Nagoya , Aichi-ken
Study Coordinator
Южна Корея (3)
Seoul National University Hospital ( Site 5100)
Seoul
Study Coordinator
Severance Hospital, Yonsei University Health System ( Site 5102)
Seoul
Study Coordinator
Samsung Medical Center ( Site 5101)
Seoul
Study Coordinator
Испания (7)
Hospital Universitari Vall d'Hebron ( Site 3311)
Barcelona
Study Coordinator
HOSPITAL CLÍNIC DE BARCELONA ( Site 3310)
Eixample , Barcelona
Study Coordinator
Institut Català d'Oncologia - L'Hospitalet ( Site 3317)
L'Hospitalet de Llobregat , Barcelona
Study Coordinator
Hospital Clinico San Carlos... ( Site 3316)
Madrid , Madrid, Comunidad de
Study Coordinator
Hospital Universitario Fundación Jiménez Díaz-START Madrid-FJD ( Site 3315)
Madrid
Study Coordinator
Hospital Universitario HM Sanchinarro ( Site 3313)
Madrid
Study Coordinator
Hospital Universitario Virgen de la Victoria ( Site 3312)
Málaga
Study Coordinator
Taiwan (2)
National Cheng Kung University Hospital ( Site 5202)
Tainan
Study Coordinator
Taipei Medical University Hospital ( Site 5201)
Taipei
Study Coordinator
Турция (2)
Hacettepe Universite Hastaneleri ( Site 3410)
Ankara
Study Coordinator
Ankara Bilkent Sehir Hastanesi ( Site 3412)
Ankara
Study Coordinator
Великобритания (3)
The Clatterbridge Cancer Centre ( Site 3903)
Liverpool
Study Coordinator
National Institute for Health Research UCLH Clinical Research Facility ( Site 3902)
London , London, City of
Study Coordinator
The Christie NHS Foundation Trust ( Site 3901)
Manchester
Study Coordinator
САЩ (9)
University of Colorado Anschutz Medical Campus ( Site 1110)
Aurora , Colorado
Study Coordinator
Dana Farber Cancer Institute ( Site 1105)
Boston , Massachusetts
Study Coordinator
Roswell Park Cancer Institute ( Site 1107)
Buffalo , New York
Study Coordinator
University of Chicago ( Site 1108)
Chicago , Illinois
Study Coordinator
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1103)
Hackensack , New Jersey
Study Coordinator
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1111)
Miami , Florida
Study Coordinator
Medical College of Wisconsin ( Site 1112)
Milwaukee , Wisconsin
Study Coordinator
Sarah Cannon Research Institute ( Site 7001)
Nashville , Tennessee
Study Coordinator
Providence Portland Medical Center ( Site 1101)
Portland , Oregon
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 1/2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
27.02.2025
Крайна дата
17.01.2030
Регистрационен номер
NCT06780137
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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