Patient Preference for Route of Administration with Intravenous Infusion Switch to Subcutaneous I-O Regimens in Melanoma
- Conditions
- MelanomaMedDRA version: 21.1Level: LLTClassification code: 10053571Term: Melanoma Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-504515-33-00
- Lead Sponsor
- Bristol-Myers Squibb Services Unlimited Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 151
The study population will be made up of men and women (who are not pregnant or breastfeeding) 18 years of age or older that have either metastatic melanoma and have not had previous treatment for their cancer, or resected melanoma and have had the cancer removed fully with surgery no later than 12 weeks before the start of treatment and confirmed free of disease. Participants must have a low level of disability and cancer that is considered advanced for metastatic melanoma and at risk for becoming advanced (intermediate) or advanced for resected melanoma.
Participants must not have any brain cancer/disease treated with radiation, any cancer in the eyes or mucous membranes (cells that cover inside surface of parts of the body and keep it moist), any autoimmune disease, or any condition that is being treated with steroids for inflammation (corticosteroids) or medication to decrease the body’s immune system response (immunosuppressive drugs).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective in both groups is to see if participants prefer their drug to be given to them one way (SC) or the other way (IV).;Secondary Objective: The secondary objective in both groups is to test the safety of the drug in participants when they switch the treatment given in the vein (IV) to under the skin (SC).;Primary end point(s): The main endpoint in both groups is the percentage of participants who prefer having the treatment given as SC more than as IV.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):The secondary endpoint in both groups is to see the side effects and abnormal laboratory tests during the study.