Phase
Condition
Melanoma
Skin Cancer
Bladder Cancer
Treatment
ONM-501
Cemiplimab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Ability to understand and willingness to sign written informed consent beforeperformance of any study procedures
Age ≥ 18 years
Participants with solid tumors or lymphomas, confirmed by available histopathologyrecords or current biopsy, that are advanced, nonresectable, or recurrent andprogressing since last antitumor therapy, and for which no alternative standardtherapy exists.
Participants must have a minimum of one injectable and measurable lesion.
Participants with prior Hepatitis B or C are eligible if they have adequate liverfunction
Participants with human immunodeficiency virus (HIV) are eligible if on establishedHAART for a minimum of 4 weeks prior to enrollment, have an HIV viral load <400copies/mL, and have CD4+ T-cell (CD4+) counts ≥ 350 cells/uL
Adequate bone marrow function:
Adequate liver function
Exclusion
Exclusion Criteria: Patients will be excluded from this study if they meet any of the following criteria (Part 1a and Part 1b).
Other malignancy active within the previous 2 years except for basal or squamouscell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix orbreast that has completed curative therapy.
Major surgery within 4 weeks before the first dose of study drug.
Brain metastases that are untreated or in the posterior fossa or involve themeninges. Participants with stable or previously treated progressing brainmetastases (except in the posterior fossa or involving the meninges) may bepermitted in a case-by-case basis at the Sponsor's discretion.
Prolongation of corrected QT (QTc) interval to >470 millisecond (ms) for males andfemales when electrolytes balance is normal.
Females who are breastfeeding or pregnant at screening or baseline
Females of childbearing potential that refuse to use a highly effective method ofcontraception.
Has uncontrolled or poorly controlled hypertension as defined by a sustained BP > 9.Has received prior investigational therapy within 5 half-lives of the agent or 4weeks before the first administration of study drug, whichever is shorter.
Has had any major cardiovascular event within 6 months prior to study drug 10. Hasknown hypersensitivity to any component in the formulation of ONM-501
Has an active infection requiring systemic treatment
Is participating in another therapeutic clinical trial
Additional Exclusion Criteria for ONM-501 in Combination with cemiplimab (Part 1b)
Has known hypersensitivity to any component in the formulation of cemiplimab
Has any active or recent history of a known or suspected autoimmune disease orrecent history of a syndrome that required systemic corticosteroids (>10 mg dailyprednisone equivalent)
Has a condition requiring systemic treatment with corticosteroids
Study Design
Study Description
Connect with a study center
St Vincent's Hospital
Darlinghurst, New South Wales 2010
AustraliaActive - Recruiting
Cancer Care Wollongong
Wollongong, New South Wales 2500
AustraliaActive - Recruiting
University of the Sunshine Coast Clinical Trials
Buderim, Queensland 4556
AustraliaActive - Recruiting
Tasman Oncology Research
Southport, Queensland 4215
AustraliaActive - Recruiting
Southern Oncology Clinical Research Unit
Bedford Park, South Australia
AustraliaActive - Recruiting
St John of God Subiaco Hospital
Subiaco, Western Australia 6008
AustraliaSite Not Available
California Research Institute
Los Angeles, California 90027
United StatesActive - Recruiting
BRCR Global
Tamarac, Florida 33321
United StatesSite Not Available
Gabrail Cancer Center Research
Canton, Ohio 44718
United StatesActive - Recruiting
Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
Allegheny Health Network
Pittsburg, Pennsylvania 15224
United StatesSite Not Available
Allegheny Health Network
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 75390
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United StatesActive - Recruiting
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