Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable … (NCT03521830) | Clinical Trial Compass
RecruitingPhase 2
Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
United States57 participantsStarted 2018-11-27
Plain-language summary
This is a phase 2 trial assessing the efficacy of nivolumab, alone or in combination with relatlimab or ipilimumab in treating patients with locally-advanced unresectable or metastatic basal cell carcinoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Signed Written Informed Consent
. Subjects must have signed and dated an Institutional Review Board (IRB)-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related procedures that are not part of normal subject care.
. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
. Type of Participant and Target Disease Characteristics
. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
. Participants with histologically confirmed Basal Cell Carcinoma with disease that is considered by the investigator to be unresectable or metastatic.
. Laboratory Testing Requirements
. White Blood Cells greater than or equal to 2000/μL
Exclusion criteria
. Medical Conditions
. Pregnant or nursing women
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate
Timeframe: 5 years
Trial details
NCT IDNCT03521830
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
. Central nervous system metastases, unless stable for at least 4 weeks and no longer requiring steroid therapy.
. Patients with an autoimmune disease or with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications may be permitted to enroll only after discussion with the study P.I.
. Participants with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
. Viral hepatitis.
. Allergies and Adverse Drug Reaction
. History of severe allergy or hypersensitivity to study drug components.