Last updated 43 days ago
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)
327 patients around the world
Available in Chile, Argentina
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.
Merck Sharp & Dohme LLC
6Research sites
327Patients around the world
This study is for people with
Lung cancer
Small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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 tissue sample or fresh biopsy tissue sample.Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART).
- Pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedure.Any history of interstitial lung disease (ILD)/pneumonitis irrespective of steroid use except for a history of radiation pneumonitis that did not require steroidsCurrent history of ILD or clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled outHas clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.History of clinically significant intracranial bleeding or spinal cord bleeding.Active neurologic paraneoplastic syndrome.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.Has other uncontrolled or significant protocol-specified cardiovascular disease.History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6 months before the first dose of study intervention.Chronic liver disease, including liver cirrhosis of Child-Pugh class B or C.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.Ongoing treatment with immunosuppressive medications, with protocol-specified exceptions.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: Other anticancer therapy, including cytotoxic agents, targeted agents, immunotherapies, antibody, retinoid, transplant, or anticancer hormonal treatment (except luteinizing hormone-releasing hormone [LHRH]) within 2 weeks before start of study intervention.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.
Sites
Sanatorio Parque - Rosario
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana
Recruiting
Instituto Oncológico FALP (Fundación Arturo López Pérez)
Recruiting
StudyMK-6070-002
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06780137
