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 range18 Years
SexALL
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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
✕. 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.
What they're measuring
1
Objective Response Rate
Timeframe: 5 years
Trial details
NCT IDNCT03521830
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins