NCT03521830 Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma
| NCT ID | NCT03521830 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| Condition | Basal Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2018-11-27 |
| Primary Completion | 2027-07 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Signed Written Informed Consent 1. 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. 2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study. 2. Type of Participant and Target Disease Characteristics 1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 2. Participants with histologically confirmed Basal Cell Carcinoma with disease that is considered by the investigator to be unresectable or metastatic. i) COHORT A: Patients with advanced BCC who are treatment-naïve (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 (nivolumab) alone. ii) COHORT B: • Patients with advanced BCC w