Phase
Condition
Neuroendocrine Carcinoma
Small Cell Lung Cancer
Treatment
MK-6070
HPN328
Atezolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Has a histologically or cytologically confirmed malignancy associated withexpression of Delta-like Canonical Notch Ligand 3 (DLL3)
Has small cell lung cancer (SCLC) which is relapsed/refractory following at least 1prior line of systemic therapy that included platinum-based chemotherapy
Has Neuroendocrine Prostate Cancer (NEPC; de novo or treatment-emergent) which isrelapsed/refractory to standard systemic therapy
Has high-grade neuroendocrine tumor types other than SCLC and NEPC, with at leastone of the following:
Disease that is relapsed/refractory to standard systemic therapy
Disease for which standard therapy does not exist
Disease for which standard therapy is not considered appropriate by theInvestigator
Must be able to provide archival tissue sample or fresh biopsy tissue sample
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Has untreated central nervous system (CNS) metastases
Has a glioma or other primary CNS malignancy
Has spinal cord compression or symptomatic/uncontrolled epidural disease
Has a history of intracranial hemorrhage or spinal cord hemorrhage
Has active neurologic paraneoplastic syndrome
Has uncontrolled pleural effusion, pericardial effusion, or ascites requiringrecurrent drainage procedures (e.g., biweekly or more frequently)
Has active or history of autoimmune disease or immune deficiency, including, but notlimited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupuserythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory boweldisease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren'ssyndrome, Guillain-Barré syndrome, or multiple sclerosis
Is ongoing treatment with immunosuppressive medications (including, but not limitedto, systemic corticosteroids [prednisone dose >10mg per day or equivalent],cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosisfactor [TNF] alpha agents) within 2 weeks prior to initiation of treatment, oranticipation of need for systemic immunosuppressive medication during studytreatment (except protocol-required pre-medications)
Has a history of clinically significant cardiovascular disease such as myocardialinfarction, symptomatic congestive heart failure (New York Heart Association > classII), and/or uncontrolled cardiac arrhythmia within 6 months of the first dose ofstudy drug
Has a history of arterial thrombosis (e.g., stroke or transient ischemic attack)within 6 months
Has active viral hepatitis, defined as hepatitis A (hepatitis A virus immunoglobulinM [IgM] positive), hepatitis B (hepatitis B virus surface antigen [HbsAg] positive),or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCVribonucleic acid). HCV with undetectable virus after treatment are eligible.Hepatitis B virus (HBV) with undetectable viral load by quantitative polymerasechain reaction (PCR) are eligible.
Has uncontrolled infection with Human Immunodeficiency Virus (HIV)-1 or HIV-2.Well-controlled HIV are eligible.
Has a history of allogeneic stem cell transplant or solid-organ transplant
Has had treatment with systemic immunostimulatory agents (including, but not limitedto, interferon and IL-2) within 4 weeks or 5 drug-elimination half-lives (whicheveris longer) prior to initiation of study treatment
Has a history of severe anaphylactic reactions to chimeric or humanized antibodiesor fusion proteins
Has a history of interstitial lung disease, idiopathic pulmonary fibrosis,organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, oridiopathic pneumonitis, or evidence of active pneumonitis on screening chestcomputed tomography (CT). History of radiation pneumonitis in the radiation field ispermitted
Has had treatment with other investigational drug within 3 weeks of scheduled dosing (or 5 half-lives of drug, whichever is shorter)
Study Design
Connect with a study center
Cedar-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California 90048
United StatesActive - Recruiting
University of California San Francisco
San Francisco, California 94143
United StatesActive - Recruiting
University of Colorado
Aurora, Colorado 80045
United StatesActive - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02467
United StatesActive - Recruiting
Karmanos Cancer Center
Detroit, Michigan 48201
United StatesActive - Recruiting
Washington University School of Medicine St. Louis
Saint Louis, Missouri 63110
United StatesSite Not Available
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
Providence
Portland, Oregon 97213
United StatesActive - Recruiting
Tennessee Oncology
Nashville, Tennessee 37203
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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