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.
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
Medical Conditions
Pregnant or nursing women
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.
Crossover
Nivolumab
Drug480mg IV every 4 weeks
Ipilimumab
Drug1mg/kg IV every 4 weeks for 4 doses
Relatlimab
Drug480 mg IV q4wks
Objective Response Rate
Objective response rate per the revised Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
progression-free survival
duration of time from start of treatment to time of progression or Basal Cell Carcinoma specific death, whichever occurs first
duration of response
duration of time that measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented
overall survival
measured from the time of enrollment until death
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead sponsor
Bristol-Myers Squibb
Collaborator
